Trial Outcomes & Findings for Pharmacokinetic and Pharmacodynamic (PK and PD) Study of Fluticasone Propionate and Salmeterol Combination Product Delivered in a Capsule-based Inhaler and in a Multi-dose Dry Powder Inhaler in Moderate Asthma Patients and Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Patients. (NCT NCT01494610)
NCT ID: NCT01494610
Last Updated: 2019-02-26
Results Overview
Blood samples of participants (par.) with asthma and chronic obstructive pulmonary disease (COPD) were collected and analyzed for AUC(0-tau), a measure of the amount of drug available at target tissue (in plasma) for a fixed dosing interval (12 hours). Asthma is a disorder that causes the airways of the lungs to swell and narrow, leading to difficulty in breathing. COPD is a chronic lung disease with structural changes in lungs, leading to difficulty in breathing.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
60 participants
Primary outcome timeframe
At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively
Results posted on
2019-02-26
Participant Flow
Participant milestones
| Measure |
FP/Salmeterol 250/50 mcg: Sequence ABBA
Participants received fluticasone propionate (FP)/salmeterol 250/50 micrograms (mcg) twice daily via a capsule-based inhaler for two 10-day periods and via a multi-dose dry powder (MDPI) inhaler for two 10-day periods in a replicate crossover design. Participants were dosed approximately every 12 hours. Treatment was given in the sequence of ABBA in Periods 1, 2, 3, and 4 (with no washouts between periods), respectively. A, FP/salmeterol from an MDPI; B, FP/salmeterol from a capsule-based inhaler.
|
FP/Salmeterol 250/50 mcg: Sequence BAAB
Participants received fluticasone propionate (FP)/salmeterol 250/50 micrograms (mcg) twice daily via a capsule-based inhaler for two 10-day periods and via a multi-dose dry powder (MDPI) inhaler for two 10-day periods in a replicate crossover design. Participants were dosed approximately every 12 hours. Treatment was given in the sequence of BAAB in Periods 1, 2, 3, and 4 (with no washouts between periods), respectively. A, FP/salmeterol from an MDPI; B, FP/salmeterol from a capsule-based inhaler.
|
|---|---|---|
|
Period 1
STARTED
|
31
|
29
|
|
Period 1
COMPLETED
|
30
|
28
|
|
Period 1
NOT COMPLETED
|
1
|
1
|
|
Period 2
STARTED
|
30
|
28
|
|
Period 2
COMPLETED
|
30
|
28
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
|
Period 3
STARTED
|
30
|
28
|
|
Period 3
COMPLETED
|
28
|
28
|
|
Period 3
NOT COMPLETED
|
2
|
0
|
|
Period 4
STARTED
|
28
|
28
|
|
Period 4
COMPLETED
|
27
|
28
|
|
Period 4
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
FP/Salmeterol 250/50 mcg: Sequence ABBA
Participants received fluticasone propionate (FP)/salmeterol 250/50 micrograms (mcg) twice daily via a capsule-based inhaler for two 10-day periods and via a multi-dose dry powder (MDPI) inhaler for two 10-day periods in a replicate crossover design. Participants were dosed approximately every 12 hours. Treatment was given in the sequence of ABBA in Periods 1, 2, 3, and 4 (with no washouts between periods), respectively. A, FP/salmeterol from an MDPI; B, FP/salmeterol from a capsule-based inhaler.
|
FP/Salmeterol 250/50 mcg: Sequence BAAB
Participants received fluticasone propionate (FP)/salmeterol 250/50 micrograms (mcg) twice daily via a capsule-based inhaler for two 10-day periods and via a multi-dose dry powder (MDPI) inhaler for two 10-day periods in a replicate crossover design. Participants were dosed approximately every 12 hours. Treatment was given in the sequence of BAAB in Periods 1, 2, 3, and 4 (with no washouts between periods), respectively. A, FP/salmeterol from an MDPI; B, FP/salmeterol from a capsule-based inhaler.
|
|---|---|---|
|
Period 1
Withdrawal by Subject
|
1
|
1
|
|
Period 3
Adverse Event
|
1
|
0
|
|
Period 3
Withdrawal by Subject
|
1
|
0
|
|
Period 4
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Pharmacokinetic and Pharmacodynamic (PK and PD) Study of Fluticasone Propionate and Salmeterol Combination Product Delivered in a Capsule-based Inhaler and in a Multi-dose Dry Powder Inhaler in Moderate Asthma Patients and Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Patients.
Baseline characteristics by cohort
| Measure |
FP/Salmeterol 250/50 mcg
n=60 Participants
Participants received fluticasone propionate (FP)/salmeterol 250/50 micrograms (mcg) twice daily via a capsule-based inhaler for two 10-day periods and via a multi-dose dry powder (MDPI) inhaler for two 10-day periods in a replicate crossover design. Participants were dosed approximately every 12 hours. Treatment was given in one of two sequences in Periods 1, 2, 3, and 4 (with no washouts between periods), respectively: ABBA, BAAB. A, FP/salmeterol from an MDPI; B, FP/salmeterol from a capsule-based inhaler.
|
|---|---|
|
Age, Continuous
Years
|
51.1 Years
STANDARD_DEVIATION 18.19 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White-White/Caucasian/European Heritage
|
56 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-Central/South Asian Heritage
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectivelyPopulation: Pharmacokinetic/pharmacodynamic (PK/PD) Population: all participants who received at least one dose of study medication, except for one who was identified as a full protocol violator. Participants with at least one non-missing value in the replicate observations were included.
Blood samples of participants (par.) with asthma and chronic obstructive pulmonary disease (COPD) were collected and analyzed for AUC(0-tau), a measure of the amount of drug available at target tissue (in plasma) for a fixed dosing interval (12 hours). Asthma is a disorder that causes the airways of the lungs to swell and narrow, leading to difficulty in breathing. COPD is a chronic lung disease with structural changes in lungs, leading to difficulty in breathing.
Outcome measures
| Measure |
FP/Salmeterol From MDPI
n=57 Participants
Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
|
FP/Salmeterol From Capsule-based Inhaler
n=57 Participants
Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
|
|---|---|---|
|
Mean Area Under the Concentration Time Curve Over the Dosing Period (AUC[0-tau]) for FP
Asthma + COPD; n=57, 57
|
376.9 Picogram hours per milliliter (pg*h/mL)
Interval 337.0 to 421.6
|
573.1 Picogram hours per milliliter (pg*h/mL)
Interval 519.3 to 632.5
|
|
Mean Area Under the Concentration Time Curve Over the Dosing Period (AUC[0-tau]) for FP
Asthma; n=33, 33
|
350.5 Picogram hours per milliliter (pg*h/mL)
Interval 296.5 to 414.4
|
559.1 Picogram hours per milliliter (pg*h/mL)
Interval 490.1 to 637.7
|
|
Mean Area Under the Concentration Time Curve Over the Dosing Period (AUC[0-tau]) for FP
COPD; n=24, 24
|
416.4 Picogram hours per milliliter (pg*h/mL)
Interval 363.1 to 477.6
|
593.0 Picogram hours per milliliter (pg*h/mL)
Interval 505.7 to 695.4
|
PRIMARY outcome
Timeframe: At pre-morning dose; 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectivelyPopulation: PK/PD Population
Participants' blood samples were collected and analyzed for SC levels. Weighted mean SC levels are evaluted as a measure of the degree of cortisol suppression, allowing for the determination of whether differences in systemic exposure to the inhaled steroid component of two devices can be significant enough to result in the differences in the body's ability to release cortisol. Weighted means were derived by calculating the AUC over the 0-12 hour period, using the linear trapezoidal rule (statistical technique used for numerical analysis) and then dividing it by the actual time interval.
Outcome measures
| Measure |
FP/Salmeterol From MDPI
n=57 Participants
Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
|
FP/Salmeterol From Capsule-based Inhaler
n=57 Participants
Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
|
|---|---|---|
|
Weighted Mean Serum Cortisol (SC) Over 0 to 12 Hours Post Dose
Asthma + COPD;n=57, 57
|
193.5 Nanomoles per liter (nmol/L)
Interval 178.7 to 209.6
|
178.3 Nanomoles per liter (nmol/L)
Interval 164.2 to 193.5
|
|
Weighted Mean Serum Cortisol (SC) Over 0 to 12 Hours Post Dose
Asthma; n=33, 33
|
187.3 Nanomoles per liter (nmol/L)
Interval 169.1 to 207.6
|
166.6 Nanomoles per liter (nmol/L)
Interval 150.4 to 184.7
|
|
Weighted Mean Serum Cortisol (SC) Over 0 to 12 Hours Post Dose
COPD; n=24, 24
|
202.4 Nanomoles per liter (nmol/L)
Interval 177.0 to 231.4
|
195.6 Nanomoles per liter (nmol/L)
Interval 171.1 to 223.7
|
SECONDARY outcome
Timeframe: At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectivelyPopulation: PK/PD Population
Blood samples of participants with asthma and COPD were collected and analyzed for AUC(0-tau) and AUC(0-tlast). AUC(0-tau) is a measure of the amount of drug available at target tissue (in plasma) for a fixed dosing interval (12 hours). AUC(0-tlast) is a measure of the plasma drug concentration from pre-dose to the last measurable concentration.
Outcome measures
| Measure |
FP/Salmeterol From MDPI
n=57 Participants
Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
|
FP/Salmeterol From Capsule-based Inhaler
n=57 Participants
Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
|
|---|---|---|
|
Mean Plasma AUC(0-tau) and Plasma AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC[0-tlast]) for Salmeterol
AUC(0-tau), asthma + COPD; n=57, 57
|
300.2 pg*h/mL
Interval 273.0 to 330.1
|
345.1 pg*h/mL
Interval 310.8 to 383.1
|
|
Mean Plasma AUC(0-tau) and Plasma AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC[0-tlast]) for Salmeterol
AUC(0-tau), asthma; n=33, 33
|
305.8 pg*h/mL
Interval 274.6 to 340.6
|
356.4 pg*h/mL
Interval 315.4 to 402.7
|
|
Mean Plasma AUC(0-tau) and Plasma AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC[0-tlast]) for Salmeterol
AUC(0-tau), COPD; n=24, 24
|
292.7 pg*h/mL
Interval 244.4 to 350.5
|
330.1 pg*h/mL
Interval 272.1 to 400.4
|
|
Mean Plasma AUC(0-tau) and Plasma AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC[0-tlast]) for Salmeterol
AUC(0-t), asthma + COPD; n=57, 57
|
303.5 pg*h/mL
Interval 277.7 to 331.7
|
345.0 pg*h/mL
Interval 310.7 to 383.0
|
|
Mean Plasma AUC(0-tau) and Plasma AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC[0-tlast]) for Salmeterol
AUC(0-t), asthma; n=33, 33
|
305.2 pg*h/mL
Interval 273.9 to 340.2
|
356.4 pg*h/mL
Interval 315.3 to 402.7
|
|
Mean Plasma AUC(0-tau) and Plasma AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC[0-tlast]) for Salmeterol
AUC(0-t), COPD; n=24, 24
|
301.2 pg*h/mL
Interval 256.9 to 353.2
|
330.0 pg*h/mL
Interval 272.0 to 400.3
|
SECONDARY outcome
Timeframe: At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectivelyPopulation: PK/PD Population
Blood samples of participants with asthma and COPD were collected and analyzed for AUC(0-tlast). AUC(0-tlast) is a measure of the plasma drug concentration from pre-dose to the last measurable concentration.
Outcome measures
| Measure |
FP/Salmeterol From MDPI
n=57 Participants
Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
|
FP/Salmeterol From Capsule-based Inhaler
n=57 Participants
Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
|
|---|---|---|
|
Mean AUC(0-tlast) for FP
Asthma; n=33, 33
|
355.7 pg*h/mL
Interval 306.0 to 413.4
|
558.4 pg*h/mL
Interval 489.6 to 636.9
|
|
Mean AUC(0-tlast) for FP
Asthma + COPD; n=57, 57
|
380.1 pg*h/mL
Interval 342.7 to 421.6
|
580.9 pg*h/mL
Interval 530.2 to 636.3
|
|
Mean AUC(0-tlast) for FP
COPD; n=24, 24
|
416.5 pg*h/mL
Interval 363.2 to 477.6
|
613.2 pg*h/mL
Interval 539.9 to 696.5
|
SECONDARY outcome
Timeframe: At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectivelyPopulation: PK/PD Population
Blood samples of participants with asthma and COPD were collected and analyzed for Cmax and Cmin of FP in the blood. Cmax and Cmin are used to estimate the time at which the activity of the drug will be at its maximum and minimum, respectively.
Outcome measures
| Measure |
FP/Salmeterol From MDPI
n=57 Participants
Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
|
FP/Salmeterol From Capsule-based Inhaler
n=57 Participants
Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
|
|---|---|---|
|
Mean Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of FP
Cmax, Asthma + COPD; n= 57, 57
|
54.64 Picograms per milliliter (pg/mL)
Interval 49.7 to 60.08
|
105.79 Picograms per milliliter (pg/mL)
Interval 95.7 to 116.95
|
|
Mean Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of FP
Cmax, Asthma; n=33, 33
|
53.66 Picograms per milliliter (pg/mL)
Interval 47.36 to 60.8
|
109.98 Picograms per milliliter (pg/mL)
Interval 95.79 to 126.27
|
|
Mean Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of FP
Cmax, COPD; n=24, 24
|
56.02 Picograms per milliliter (pg/mL)
Interval 47.91 to 65.5
|
100.29 Picograms per milliliter (pg/mL)
Interval 86.06 to 116.87
|
|
Mean Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of FP
Cmin, Asthma + COPD; n=57, 57
|
15.904 Picograms per milliliter (pg/mL)
Interval 14.025 to 18.035
|
21.547 Picograms per milliliter (pg/mL)
Interval 19.198 to 24.183
|
|
Mean Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of FP
Cmin, Asthma; n=33, 33
|
13.635 Picograms per milliliter (pg/mL)
Interval 11.448 to 16.239
|
18.866 Picograms per milliliter (pg/mL)
Interval 15.979 to 22.273
|
|
Mean Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of FP
Cmin, COPD; n=24, 24
|
19.654 Picograms per milliliter (pg/mL)
Interval 16.898 to 22.859
|
25.866 Picograms per milliliter (pg/mL)
Interval 22.703 to 29.47
|
SECONDARY outcome
Timeframe: At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectivelyPopulation: PK/PD Population. Only those participants contributing data at the indicated time points were analyzed.
Blood samples of participants were collected for evaluating t1/2. The t1/2 is the time required for the plasma/blood concentration of the drug to decrease by 50% after the false equilibrium of distribution has been reached.
Outcome measures
| Measure |
FP/Salmeterol From MDPI
n=54 Participants
Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
|
FP/Salmeterol From Capsule-based Inhaler
n=55 Participants
Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
|
|---|---|---|
|
Mean Terminal Phase Half-life (t1/2) for FP
Asthma + COPD; n=54, 55
|
6.660 hours
Interval 6.164 to 7.197
|
5.844 hours
Interval 5.416 to 6.307
|
|
Mean Terminal Phase Half-life (t1/2) for FP
Asthma; n=30, 32
|
5.906 hours
Interval 5.402 to 6.458
|
5.238 hours
Interval 4.789 to 5.729
|
|
Mean Terminal Phase Half-life (t1/2) for FP
COPD; n=24, 23
|
7.740 hours
Interval 6.915 to 8.663
|
6.806 hours
Interval 6.089 to 7.607
|
SECONDARY outcome
Timeframe: At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectivelyPopulation: PK/PD Population
Blood samples of participants were collected for evaluating Tmax. Tmax is a measure of the time required to reach the maximum concentration of the drug.
Outcome measures
| Measure |
FP/Salmeterol From MDPI
n=57 Participants
Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
|
FP/Salmeterol From Capsule-based Inhaler
n=57 Participants
Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
|
|---|---|---|
|
Time of Occurrence of Cmax (Tmax) for FP
Asthma + COPD; n=57, 57
|
1.045 hours
Interval 0.08 to 5.0
|
0.530 hours
Interval 0.08 to 2.04
|
|
Time of Occurrence of Cmax (Tmax) for FP
Asthma; n=33, 33
|
1.000 hours
Interval 0.08 to 4.04
|
0.335 hours
Interval 0.08 to 2.04
|
|
Time of Occurrence of Cmax (Tmax) for FP
COPD; n=24, 24
|
1.173 hours
Interval 0.17 to 5.0
|
0.673 hours
Interval 0.13 to 1.54
|
SECONDARY outcome
Timeframe: At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectivelyPopulation: PK/PD Population
Blood samples of participants with asthma and COPD were collected and analyzed for Cmax and Cmin of Salmeterol in the blood. Cmax and Cmin are used to estimate the time at which the activity of the drug will be at its maximum and minimum.
Outcome measures
| Measure |
FP/Salmeterol From MDPI
n=57 Participants
Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
|
FP/Salmeterol From Capsule-based Inhaler
n=57 Participants
Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
|
|---|---|---|
|
Mean Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) for Salmeterol
Cmax, Asthma + COPD; n=57, 57
|
59.28 pg/mL
Interval 53.45 to 65.74
|
92.27 pg/mL
Interval 80.52 to 105.75
|
|
Mean Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) for Salmeterol
Cmax, Asthma; n=33, 33
|
64.97 pg/mL
Interval 56.53 to 74.66
|
110.21 pg/mL
Interval 94.76 to 128.19
|
|
Mean Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) for Salmeterol
Cmax, COPD; n=24, 24
|
52.26 pg/mL
Interval 44.94 to 60.77
|
72.27 pg/mL
Interval 57.75 to 90.45
|
|
Mean Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) for Salmeterol
Cmin, Asthma + COPD; n=57, 57
|
12.752 pg/mL
Interval 11.504 to 14.134
|
14.354 pg/mL
Interval 12.859 to 16.024
|
|
Mean Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) for Salmeterol
Cmin, Asthma; n=33, 33
|
12.676 pg/mL
Interval 11.097 to 14.479
|
14.634 pg/mL
Interval 12.806 to 16.723
|
|
Mean Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) for Salmeterol
Cmin, COPD; n=24, 24
|
12.857 pg/mL
Interval 10.798 to 15.307
|
13.978 pg/mL
Interval 11.464 to 17.044
|
SECONDARY outcome
Timeframe: At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectivelyPopulation: PK/PD Population. Only those participants contributing data at the indicated time points were analyzed.
Blood samples of participants were collected for evaluating t1/2. t1/2 is the time required for the plasma/blood concentration of the drug to decrease by 50% after the false equilibrium of distribution has been reached.
Outcome measures
| Measure |
FP/Salmeterol From MDPI
n=56 Participants
Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
|
FP/Salmeterol From Capsule-based Inhaler
n=56 Participants
Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
|
|---|---|---|
|
Mean Terminal Phase Half-life (t1/2) for Salmeterol
Asthma + COPD; n=56, 56
|
6.576 hours
Interval 6.08 to 7.112
|
7.260 hours
Interval 6.792 to 7.761
|
|
Mean Terminal Phase Half-life (t1/2) for Salmeterol
Asthma; n=32, 32
|
6.429 hours
Interval 6.021 to 6.865
|
7.538 hours
Interval 6.84 to 8.308
|
|
Mean Terminal Phase Half-life (t1/2) for Salmeterol
COPD; n=24, 24
|
6.776 hours
Interval 5.727 to 8.018
|
6.905 hours
Interval 6.309 to 7.558
|
SECONDARY outcome
Timeframe: At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectivelyPopulation: PK/PD Population
Blood samples of participants were collected for evaluating Tmax. Tmax is a measure of the time required to reach the maximum concentration of the drug.
Outcome measures
| Measure |
FP/Salmeterol From MDPI
n=57 Participants
Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
|
FP/Salmeterol From Capsule-based Inhaler
n=57 Participants
Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
|
|---|---|---|
|
Tmax for Salmeterol
Asthma + COPD; n=57, 57
|
0.750 hours
Interval 0.08 to 6.5
|
0.080 hours
Interval 0.08 to 6.5
|
|
Tmax for Salmeterol
Asthma; n=33, 33
|
0.335 hours
Interval 0.08 to 6.5
|
0.080 hours
Interval 0.08 to 1.04
|
|
Tmax for Salmeterol
COPD; n=24, 24
|
1.000 hours
Interval 0.08 to 2.0
|
0.080 hours
Interval 0.08 to 6.5
|
SECONDARY outcome
Timeframe: 0-24 hours post dose on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectivelyPopulation: PK/PD Population
Urine samples of participants were collected to evaluate urine cortisol excretion over 0-24 hours post treatment dose. A 24-hour urine cortisol sample was used to measure the total amount of cortisol excreted in urine in 24 hours. Any differences in systemic exposure as a result of the absorbed steroid component of the two differing inhaled devices should also result in differences in the amount of cortisol excreted in the urine.
Outcome measures
| Measure |
FP/Salmeterol From MDPI
n=57 Participants
Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
|
FP/Salmeterol From Capsule-based Inhaler
n=57 Participants
Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
|
|---|---|---|
|
Mean Urine Cortisol Excretion Over 0 to 24 Hours Post Dose for FP
Asthma + COPD; n=57, 57
|
63.53 nmol
Interval 56.71 to 71.17
|
59.66 nmol
Interval 51.45 to 69.18
|
|
Mean Urine Cortisol Excretion Over 0 to 24 Hours Post Dose for FP
Asthma; n=33, 33
|
72.86 nmol
Interval 62.97 to 84.32
|
66.28 nmol
Interval 55.25 to 79.51
|
|
Mean Urine Cortisol Excretion Over 0 to 24 Hours Post Dose for FP
COPD; n=24, 24
|
52.62 nmol
Interval 44.77 to 61.83
|
51.62 nmol
Interval 40.16 to 66.35
|
SECONDARY outcome
Timeframe: Day 10 of each study period (Periods 1-4); Study Day 10 (+/-1) (reference day is Study Day 1 or Randomization day), Period 1; Study Day 20 (+/-1), Period 2; Study Day 30 (+/-1), Period 3; Study Day 40 (+/-1), Period 4Population: PK/PD Population
Blood samples of participants were collected for the evaluation of minimum serum cortisol. Any differences in systemic exposure as a result of the absorbed steroid component of the two differing inhaled devices should also result in differences in serum cortisol concentrations.
Outcome measures
| Measure |
FP/Salmeterol From MDPI
n=57 Participants
Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
|
FP/Salmeterol From Capsule-based Inhaler
n=57 Participants
Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
|
|---|---|---|
|
Serum Cortisol Minimum (Cmin) for FP
Asthma + COPD; n=57, 57
|
88.6 nmol/L
Interval 77.9 to 100.8
|
79.6 nmol/L
Interval 69.0 to 91.7
|
|
Serum Cortisol Minimum (Cmin) for FP
Asthma; n=33, 33
|
79.8 nmol/L
Interval 67.0 to 95.0
|
70.0 nmol/L
Interval 57.8 to 84.7
|
|
Serum Cortisol Minimum (Cmin) for FP
COPD; n=24, 24
|
102.4 nmol/L
Interval 85.0 to 123.3
|
94.9 nmol/L
Interval 77.1 to 116.8
|
SECONDARY outcome
Timeframe: At pre-morning dose; 15, 30, 60, 90 minutes post-dose (PD); and 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectivelyPopulation: PK/PD Population
The heart rate (number of heartbeats per unit of time, typically expressed as beats per minute \[bpm\]) of the participants was monitored for evaluating the weighted mean over the course of 0 to 4 hours post dose. The Capsule-MDPI difference for heart rate was calculated for each participant, and the weighted mean value from the time of the morning dose on Day 10 to 4 hours post dose was calculated. The weighted mean was calculated by using all values at the indicated timepoint contributing to the calculation of the mean but with different weightage.
Outcome measures
| Measure |
FP/Salmeterol From MDPI
n=57 Participants
Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
|
FP/Salmeterol From Capsule-based Inhaler
n=57 Participants
Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
|
|---|---|---|
|
Weighted Mean Over 0 to 4 Hours Post Dose of Heart Rate for Salmeterol
Asthma + COPD; n=57, 57
|
66.2 bpm
Standard Deviation 8.66
|
66.7 bpm
Standard Deviation 8.70
|
|
Weighted Mean Over 0 to 4 Hours Post Dose of Heart Rate for Salmeterol
Asthma; n=33, 33
|
64.8 bpm
Standard Deviation 8.99
|
65.7 bpm
Standard Deviation 9.49
|
|
Weighted Mean Over 0 to 4 Hours Post Dose of Heart Rate for Salmeterol
COPD; n=24, 24
|
68.2 bpm
Standard Deviation 7.96
|
68.1 bpm
Standard Deviation 7.45
|
SECONDARY outcome
Timeframe: At pre-morning dose; 15, 30, 60, 90 minutes post-dose (PD); and 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectivelyPopulation: PK/PD Population
The maximum observed value of heart rate was measured from the time of the morning dose on Day 10 to 4 hours post dose.
Outcome measures
| Measure |
FP/Salmeterol From MDPI
n=57 Participants
Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
|
FP/Salmeterol From Capsule-based Inhaler
n=57 Participants
Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
|
|---|---|---|
|
Mean of Maximum Heart Rate Over 0 to 4 Hours Post Dose for Salmeterol
Asthma + COPD; n=57, 57
|
73.0 bpm
Standard Deviation 9.86
|
74.3 bpm
Standard Deviation 9.08
|
|
Mean of Maximum Heart Rate Over 0 to 4 Hours Post Dose for Salmeterol
Asthma; n=33, 33
|
72.3 bpm
Standard Deviation 10.52
|
73.5 bpm
Standard Deviation 9.62
|
|
Mean of Maximum Heart Rate Over 0 to 4 Hours Post Dose for Salmeterol
COPD; n=24, 24
|
74.0 bpm
Standard Deviation 8.98
|
75.4 bpm
Standard Deviation 8.35
|
SECONDARY outcome
Timeframe: At pre-morning dose; 15, 30, 60, 90 minutes post-dose (PD); and 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectivelyPopulation: PK/PD Population
The diastolic and systolic blood pressure of the participants was measured. The maximum and minimum observed values from the time of the morning dose on Day 10 to 4 hours post dose were measured for SBP and DBP. The weighted mean value from the time of the morning dose on Day 10 to 4 hours post dose was calculated. Weighted mean was calculated by using all values of DBP and SBP at the indicated timepoint contributing to the calculation of the mean but with different weightage.
Outcome measures
| Measure |
FP/Salmeterol From MDPI
n=57 Participants
Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
|
FP/Salmeterol From Capsule-based Inhaler
n=57 Participants
Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
|
|---|---|---|
|
Minimum Diastolic Blood Pressure (DBP), Maximum Systolic Blood Pressure (SBP), and Weighted Mean for DBP and SBP Over 0 to 4 Hours Post Dose
DBP, Asthma + COPD; n=57, 57
|
64.7 millimeters of mercury (mmHg)
Standard Deviation 8.16
|
66.2 millimeters of mercury (mmHg)
Standard Deviation 8.12
|
|
Minimum Diastolic Blood Pressure (DBP), Maximum Systolic Blood Pressure (SBP), and Weighted Mean for DBP and SBP Over 0 to 4 Hours Post Dose
DBP, Asthma; n=33, 33
|
61.6 millimeters of mercury (mmHg)
Standard Deviation 6.66
|
62.6 millimeters of mercury (mmHg)
Standard Deviation 5.27
|
|
Minimum Diastolic Blood Pressure (DBP), Maximum Systolic Blood Pressure (SBP), and Weighted Mean for DBP and SBP Over 0 to 4 Hours Post Dose
DBP, COPD; n=24, 24
|
69.1 millimeters of mercury (mmHg)
Standard Deviation 8.14
|
71.2 millimeters of mercury (mmHg)
Standard Deviation 8.83
|
|
Minimum Diastolic Blood Pressure (DBP), Maximum Systolic Blood Pressure (SBP), and Weighted Mean for DBP and SBP Over 0 to 4 Hours Post Dose
Weighted mean DBP, Asthma + COPD; n=57, 57
|
71.1 millimeters of mercury (mmHg)
Standard Deviation 7.85
|
72.2 millimeters of mercury (mmHg)
Standard Deviation 8.13
|
|
Minimum Diastolic Blood Pressure (DBP), Maximum Systolic Blood Pressure (SBP), and Weighted Mean for DBP and SBP Over 0 to 4 Hours Post Dose
Weighted mean DBP, Asthma; n=33, 33
|
68.0 millimeters of mercury (mmHg)
Standard Deviation 5.69
|
68.8 millimeters of mercury (mmHg)
Standard Deviation 5.26
|
|
Minimum Diastolic Blood Pressure (DBP), Maximum Systolic Blood Pressure (SBP), and Weighted Mean for DBP and SBP Over 0 to 4 Hours Post Dose
Weighted mean DBP, COPD; n=24, 24
|
75.4 millimeters of mercury (mmHg)
Standard Deviation 8.18
|
77.0 millimeters of mercury (mmHg)
Standard Deviation 9.04
|
|
Minimum Diastolic Blood Pressure (DBP), Maximum Systolic Blood Pressure (SBP), and Weighted Mean for DBP and SBP Over 0 to 4 Hours Post Dose
SBP, Asthma + COPD; n=57, 57
|
128.0 millimeters of mercury (mmHg)
Standard Deviation 14.26
|
129.3 millimeters of mercury (mmHg)
Standard Deviation 13.63
|
|
Minimum Diastolic Blood Pressure (DBP), Maximum Systolic Blood Pressure (SBP), and Weighted Mean for DBP and SBP Over 0 to 4 Hours Post Dose
SBP, Asthma; n=33, 33
|
119.9 millimeters of mercury (mmHg)
Standard Deviation 8.25
|
122.1 millimeters of mercury (mmHg)
Standard Deviation 9.08
|
|
Minimum Diastolic Blood Pressure (DBP), Maximum Systolic Blood Pressure (SBP), and Weighted Mean for DBP and SBP Over 0 to 4 Hours Post Dose
SBP, COPD; n=24, 24
|
139.1 millimeters of mercury (mmHg)
Standard Deviation 13.29
|
139.1 millimeters of mercury (mmHg)
Standard Deviation 12.82
|
|
Minimum Diastolic Blood Pressure (DBP), Maximum Systolic Blood Pressure (SBP), and Weighted Mean for DBP and SBP Over 0 to 4 Hours Post Dose
Weighted mean SBP, Asthma + COPD; n=57, 57
|
118.8 millimeters of mercury (mmHg)
Standard Deviation 11.78
|
120.3 millimeters of mercury (mmHg)
Standard Deviation 11.69
|
|
Minimum Diastolic Blood Pressure (DBP), Maximum Systolic Blood Pressure (SBP), and Weighted Mean for DBP and SBP Over 0 to 4 Hours Post Dose
Weighted mean SBP, Asthma; n=33, 33
|
112.9 millimeters of mercury (mmHg)
Standard Deviation 7.97
|
114.6 millimeters of mercury (mmHg)
Standard Deviation 8.25
|
|
Minimum Diastolic Blood Pressure (DBP), Maximum Systolic Blood Pressure (SBP), and Weighted Mean for DBP and SBP Over 0 to 4 Hours Post Dose
Weighted mean SBP, COPD; n=24, 24
|
126.9 millimeters of mercury (mmHg)
Standard Deviation 11.44
|
128.2 millimeters of mercury (mmHg)
Standard Deviation 11.21
|
SECONDARY outcome
Timeframe: At pre-morning dose; 15, 30, 60, 90 minutes post-dose (PD); and 2, 3 and 4 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectivelyPopulation: PK/PD Population
The electrocardiogram (ECG) of the participants was taken, and the maximum and weighted mean of QTc(B) and QTc(F) was measured. Weighted mean was calculated by using all values of QTc(B) and QTc(F) at the indicated timepoint contributing to the calculation of the mean but with different weightage. The ECG helps in the assessment of the condition of the heart. The QT interval gives the measure of the heart rate, and the cQT interval gives the corrected value.
Outcome measures
| Measure |
FP/Salmeterol From MDPI
n=57 Participants
Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
|
FP/Salmeterol From Capsule-based Inhaler
n=57 Participants
Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
|
|---|---|---|
|
Maximum and Weighted Mean Over 0 to 4 Hours Post Dose of the QT Interval Corrected According to Bazett's Formula (QTc[B]) and the QT Interval Corrected According to Fridericia's Formula (QTc[F])
Max QTc(F), Asthma; n=33, 33
|
413.5 Milliseconds (msec)
Standard Deviation 15.01
|
413.7 Milliseconds (msec)
Standard Deviation 17.52
|
|
Maximum and Weighted Mean Over 0 to 4 Hours Post Dose of the QT Interval Corrected According to Bazett's Formula (QTc[B]) and the QT Interval Corrected According to Fridericia's Formula (QTc[F])
Max QTc(F), COPD; n=24, 24
|
434.9 Milliseconds (msec)
Standard Deviation 17.83
|
434.9 Milliseconds (msec)
Standard Deviation 22.96
|
|
Maximum and Weighted Mean Over 0 to 4 Hours Post Dose of the QT Interval Corrected According to Bazett's Formula (QTc[B]) and the QT Interval Corrected According to Fridericia's Formula (QTc[F])
Weighted mean QTc(F), Asthma + COPD; n=57, 57
|
410.3 Milliseconds (msec)
Standard Deviation 19.34
|
410.1 Milliseconds (msec)
Standard Deviation 20.28
|
|
Maximum and Weighted Mean Over 0 to 4 Hours Post Dose of the QT Interval Corrected According to Bazett's Formula (QTc[B]) and the QT Interval Corrected According to Fridericia's Formula (QTc[F])
Weighted mean QTc(F), Asthma; n=33, 33
|
401.2 Milliseconds (msec)
Standard Deviation 15.03
|
401.3 Milliseconds (msec)
Standard Deviation 17.13
|
|
Maximum and Weighted Mean Over 0 to 4 Hours Post Dose of the QT Interval Corrected According to Bazett's Formula (QTc[B]) and the QT Interval Corrected According to Fridericia's Formula (QTc[F])
Weighted mean QTc(F), COPD; n=24, 24
|
422.9 Milliseconds (msec)
Standard Deviation 17.63
|
422.3 Milliseconds (msec)
Standard Deviation 18.06
|
|
Maximum and Weighted Mean Over 0 to 4 Hours Post Dose of the QT Interval Corrected According to Bazett's Formula (QTc[B]) and the QT Interval Corrected According to Fridericia's Formula (QTc[F])
Max, QTc(B) interval, Asthma + COPD; n=57, 57
|
434.0 Milliseconds (msec)
Standard Deviation 22.49
|
434.4 Milliseconds (msec)
Standard Deviation 25.39
|
|
Maximum and Weighted Mean Over 0 to 4 Hours Post Dose of the QT Interval Corrected According to Bazett's Formula (QTc[B]) and the QT Interval Corrected According to Fridericia's Formula (QTc[F])
Max, QTc(B) interval, Asthma; n=33, 33
|
423.7 Milliseconds (msec)
Standard Deviation 18.22
|
424.7 Milliseconds (msec)
Standard Deviation 19.86
|
|
Maximum and Weighted Mean Over 0 to 4 Hours Post Dose of the QT Interval Corrected According to Bazett's Formula (QTc[B]) and the QT Interval Corrected According to Fridericia's Formula (QTc[F])
Max, QTc(B) interval, COPD; n=24, 24
|
448.1 Milliseconds (msec)
Standard Deviation 20.29
|
447.6 Milliseconds (msec)
Standard Deviation 26.53
|
|
Maximum and Weighted Mean Over 0 to 4 Hours Post Dose of the QT Interval Corrected According to Bazett's Formula (QTc[B]) and the QT Interval Corrected According to Fridericia's Formula (QTc[F])
Weighted mean QTc(B), Asthma + COPD; n=57, 57
|
416.8 Milliseconds (msec)
Standard Deviation 23.24
|
416.8 Milliseconds (msec)
Standard Deviation 24.23
|
|
Maximum and Weighted Mean Over 0 to 4 Hours Post Dose of the QT Interval Corrected According to Bazett's Formula (QTc[B]) and the QT Interval Corrected According to Fridericia's Formula (QTc[F])
Weighted mean QTc(B), Asthma; n=33, 33
|
405.7 Milliseconds (msec)
Standard Deviation 18.61
|
406.3 Milliseconds (msec)
Standard Deviation 20.81
|
|
Maximum and Weighted Mean Over 0 to 4 Hours Post Dose of the QT Interval Corrected According to Bazett's Formula (QTc[B]) and the QT Interval Corrected According to Fridericia's Formula (QTc[F])
Weighted mean QTc(B), COPD; n=24, 24
|
431.9 Milliseconds (msec)
Standard Deviation 20.48
|
431.3 Milliseconds (msec)
Standard Deviation 21.25
|
|
Maximum and Weighted Mean Over 0 to 4 Hours Post Dose of the QT Interval Corrected According to Bazett's Formula (QTc[B]) and the QT Interval Corrected According to Fridericia's Formula (QTc[F])
Max QTc(F), Asthma + COPD; n=57, 57
|
422.5 Milliseconds (msec)
Standard Deviation 19.31
|
422.6 Milliseconds (msec)
Standard Deviation 22.43
|
SECONDARY outcome
Timeframe: At pre-morning dose; 30, 60 minutes post-dose (PD); and 2 and 4 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectivelyPopulation: Only those participants contributing data at the indicated time points were analyzed.
Blood samples of participants were collected for the evaluation of weighted mean over 0 to 4 hours post dose and the minimum plasma potassium level. Weighted mean was calculated by using all values of plasma potassium at the indicated timepoint contributing to the calculation of the mean but with different weightage.
Outcome measures
| Measure |
FP/Salmeterol From MDPI
n=57 Participants
Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
|
FP/Salmeterol From Capsule-based Inhaler
n=57 Participants
Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
|
|---|---|---|
|
Weighted Mean Over 0 to 4 Hours Post Dose of Plasma Potassium and Minimum (Min) Plasma Potassium
Weighted mean, Asthma + COPD; n=56, 57
|
4.11 Millimoles per liter (mmol/L)
Standard Deviation 0.209
|
4.11 Millimoles per liter (mmol/L)
Standard Deviation 0.228
|
|
Weighted Mean Over 0 to 4 Hours Post Dose of Plasma Potassium and Minimum (Min) Plasma Potassium
Weighted mean, Asthma; n=32, 33
|
4.11 Millimoles per liter (mmol/L)
Standard Deviation 0.216
|
4.10 Millimoles per liter (mmol/L)
Standard Deviation 0.242
|
|
Weighted Mean Over 0 to 4 Hours Post Dose of Plasma Potassium and Minimum (Min) Plasma Potassium
Weighted mean, COPD; n=24, 24
|
4.11 Millimoles per liter (mmol/L)
Standard Deviation 0.204
|
4.13 Millimoles per liter (mmol/L)
Standard Deviation 0.210
|
|
Weighted Mean Over 0 to 4 Hours Post Dose of Plasma Potassium and Minimum (Min) Plasma Potassium
Min, Asthma + COPD; n=57, 57
|
3.91 Millimoles per liter (mmol/L)
Standard Deviation 0.231
|
3.90 Millimoles per liter (mmol/L)
Standard Deviation 0.249
|
|
Weighted Mean Over 0 to 4 Hours Post Dose of Plasma Potassium and Minimum (Min) Plasma Potassium
Min, Asthma; n=33, 33
|
3.92 Millimoles per liter (mmol/L)
Standard Deviation 0.241
|
3.89 Millimoles per liter (mmol/L)
Standard Deviation 0.269
|
|
Weighted Mean Over 0 to 4 Hours Post Dose of Plasma Potassium and Minimum (Min) Plasma Potassium
Min, COPD; n=24, 24
|
3.89 Millimoles per liter (mmol/L)
Standard Deviation 0.220
|
3.92 Millimoles per liter (mmol/L)
Standard Deviation 0.221
|
SECONDARY outcome
Timeframe: At pre-morning dose; 30, 60 minutes post-dose (PD); and 2 and 4 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectivelyPopulation: PK/PD Population
Blood samples of participants were collected for the evaluation of weighted mean over 0 to 4 hours post dose and the maximum plasma glucose level. Weighted mean was calculated by using all values of plasma glucose at the indicated timepoint contributing to the calculation of the mean but with different weightage.
Outcome measures
| Measure |
FP/Salmeterol From MDPI
n=57 Participants
Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
|
FP/Salmeterol From Capsule-based Inhaler
n=57 Participants
Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
|
|---|---|---|
|
Weighted Mean Over 0 to 4 Hours Post Dose and Maximum Plasma Glucose
Weighted mean, Asthma + COPD; n=57, 57
|
5.85 mmol/L
Standard Deviation 1.119
|
5.95 mmol/L
Standard Deviation 0.999
|
|
Weighted Mean Over 0 to 4 Hours Post Dose and Maximum Plasma Glucose
Weighted mean, Asthma; n=33, 33
|
5.67 mmol/L
Standard Deviation 0.622
|
5.80 mmol/L
Standard Deviation 0.654
|
|
Weighted Mean Over 0 to 4 Hours Post Dose and Maximum Plasma Glucose
Weighted mean, COPD; n=24, 24
|
6.11 mmol/L
Standard Deviation 1.545
|
6.16 mmol/L
Standard Deviation 1.325
|
|
Weighted Mean Over 0 to 4 Hours Post Dose and Maximum Plasma Glucose
Max, Asthma + COPD; n=57, 57
|
6.94 mmol/L
Standard Deviation 1.644
|
7.19 mmol/L
Standard Deviation 1.614
|
|
Weighted Mean Over 0 to 4 Hours Post Dose and Maximum Plasma Glucose
Max, Asthma; n=33, 33
|
6.64 mmol/L
Standard Deviation 1.147
|
6.96 mmol/L
Standard Deviation 1.125
|
|
Weighted Mean Over 0 to 4 Hours Post Dose and Maximum Plasma Glucose
Max, COPD; n=24, 24
|
7.36 mmol/L
Standard Deviation 2.105
|
7.50 mmol/L
Standard Deviation 2.098
|
SECONDARY outcome
Timeframe: Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectivelyPopulation: All Subjects Population: all participants who received at least one dose of study medication. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.
Blood samples of participants were collected for the evaluation of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, and WBC count. Data are reported for the first (1st) and second (2nd) administration (admin) of FP/salmeterol via MDPI or capsule-based inhaler. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was "ABBA," then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A.
Outcome measures
| Measure |
FP/Salmeterol From MDPI
n=33 Participants
Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
|
FP/Salmeterol From Capsule-based Inhaler
n=33 Participants
Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
|
|---|---|---|
|
Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count
Basophils, 1st admin, Asthma; n=33, 33
|
0.05 Giga (10^9) cells/L
Standard Deviation 0.051
|
0.06 Giga (10^9) cells/L
Standard Deviation 0.082
|
|
Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count
Basophils, 2nd admin, Asthma; n=31, 33
|
0.04 Giga (10^9) cells/L
Standard Deviation 0.050
|
0.04 Giga (10^9) cells/L
Standard Deviation 0.050
|
|
Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count
Basophils, 1st admin, COPD; n=25, 25
|
0.07 Giga (10^9) cells/L
Standard Deviation 0.085
|
0.04 Giga (10^9) cells/L
Standard Deviation 0.050
|
|
Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count
Basophils, 2nd admin, COPD; n=24, 25
|
0.04 Giga (10^9) cells/L
Standard Deviation 0.050
|
0.04 Giga (10^9) cells/L
Standard Deviation 0.050
|
|
Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count
Eosinophils, 1st admin, Asthma; n=33, 33
|
0.37 Giga (10^9) cells/L
Standard Deviation 0.238
|
0.33 Giga (10^9) cells/L
Standard Deviation 0.187
|
|
Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count
Eosinophils, 2nd admin, Asthma; n=31, 33
|
0.31 Giga (10^9) cells/L
Standard Deviation 0.182
|
0.31 Giga (10^9) cells/L
Standard Deviation 0.189
|
|
Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count
Eosinophils, 1st admin, COPD; n=25, 25
|
0.25 Giga (10^9) cells/L
Standard Deviation 0.169
|
0.23 Giga (10^9) cells/L
Standard Deviation 0.173
|
|
Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count
Eosinophils, 2nd admin, COPD; n=24, 25
|
0.25 Giga (10^9) cells/L
Standard Deviation 0.169
|
0.26 Giga (10^9) cells/L
Standard Deviation 0.171
|
|
Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count
Lymphocytes, 1st admin, Asthma; n=33, 33
|
1.96 Giga (10^9) cells/L
Standard Deviation 0.497
|
1.92 Giga (10^9) cells/L
Standard Deviation 0.454
|
|
Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count
Lymphocytes, 2nd admin, Asthma; n=31,33
|
1.90 Giga (10^9) cells/L
Standard Deviation 0.461
|
1.86 Giga (10^9) cells/L
Standard Deviation 0.478
|
|
Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count
Lymphocytes, 1st admin, COPD; n=25, 25
|
1.70 Giga (10^9) cells/L
Standard Deviation 0.419
|
1.72 Giga (10^9) cells/L
Standard Deviation 0.472
|
|
Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count
Lymphocytes, 2nd admin, COPD; n=24, 25
|
1.75 Giga (10^9) cells/L
Standard Deviation 0.475
|
1.68 Giga (10^9) cells/L
Standard Deviation 0.352
|
|
Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count
Monocytes, 1st admin, Asthma; n=33, 33
|
0.54 Giga (10^9) cells/L
Standard Deviation 0.162
|
0.55 Giga (10^9) cells/L
Standard Deviation 0.175
|
|
Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count
Monocytes, 2nd admin, Asthma; n=31, 33
|
0.54 Giga (10^9) cells/L
Standard Deviation 0.133
|
0.52 Giga (10^9) cells/L
Standard Deviation 0.156
|
|
Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count
Monocytes, 1st admin, COPD; n=25, 25
|
0.64 Giga (10^9) cells/L
Standard Deviation 0.161
|
0.60 Giga (10^9) cells/L
Standard Deviation 0.181
|
|
Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count
Monocytes, 2nd admin, COPD; n=24, 25
|
0.63 Giga (10^9) cells/L
Standard Deviation 0.157
|
0.63 Giga (10^9) cells/L
Standard Deviation 0.170
|
|
Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count
TN, 1st admin, Asthma; n=33, 33
|
3.28 Giga (10^9) cells/L
Standard Deviation 1.097
|
3.37 Giga (10^9) cells/L
Standard Deviation 1.036
|
|
Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count
TN, 2nd admin, Asthma; n=31, 33
|
3.30 Giga (10^9) cells/L
Standard Deviation 0.904
|
3.28 Giga (10^9) cells/L
Standard Deviation 1.083
|
|
Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count
TN, 1st admin, COPD; n=25, 25
|
3.70 Giga (10^9) cells/L
Standard Deviation 1.601
|
3.48 Giga (10^9) cells/L
Standard Deviation 1.059
|
|
Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count
TN, 2nd admin, COPD; n=24, 25
|
3.45 Giga (10^9) cells/L
Standard Deviation 1.060
|
3.75 Giga (10^9) cells/L
Standard Deviation 1.595
|
|
Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count
Platelet count, 1st admin, Asthma; n=33, 33
|
225.1 Giga (10^9) cells/L
Standard Deviation 40.05
|
223.9 Giga (10^9) cells/L
Standard Deviation 41.64
|
|
Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count
Platelet count, 2nd admin, Asthma; n=31, 33
|
230.7 Giga (10^9) cells/L
Standard Deviation 43.08
|
230.8 Giga (10^9) cells/L
Standard Deviation 49.90
|
|
Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count
Platelet count, 1st admin, COPD; n=24, 24
|
230.6 Giga (10^9) cells/L
Standard Deviation 50.56
|
226.6 Giga (10^9) cells/L
Standard Deviation 52.85
|
|
Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count
Platelet count, 2nd admin, COPD; n=23, 24
|
235.1 Giga (10^9) cells/L
Standard Deviation 52.73
|
240.1 Giga (10^9) cells/L
Standard Deviation 48.78
|
|
Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count
WBC count, 1st admin, Asthma; n=33, 33
|
6.145 Giga (10^9) cells/L
Standard Deviation 1.3253
|
6.182 Giga (10^9) cells/L
Standard Deviation 1.3646
|
|
Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count
WBC count, 2nd admin, Asthma; n=31, 33
|
6.071 Giga (10^9) cells/L
Standard Deviation 1.1892
|
5.976 Giga (10^9) cells/L
Standard Deviation 1.3528
|
|
Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count
WBC count, 1st admin, COPD; n=25, 25
|
6.340 Giga (10^9) cells/L
Standard Deviation 1.9346
|
6.036 Giga (10^9) cells/L
Standard Deviation 1.3076
|
|
Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count
WBC count, 2nd admin, COPD; n=24, 25
|
6.092 Giga (10^9) cells/L
Standard Deviation 1.2752
|
6.312 Giga (10^9) cells/L
Standard Deviation 1.8600
|
SECONDARY outcome
Timeframe: Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectivelyPopulation: All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.
Blood samples of participants were collected for the evaluation of mean hemoglobin (mean level of hemoglobin in the whole blood sample) and MCH concentration. The MCH concentration is the average concentration of hemoglobin in a red blood cell. Hemoglobin is the red pigment in the blood, and it is reponsible for carrying oxygen. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was "ABBA," then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A.
Outcome measures
| Measure |
FP/Salmeterol From MDPI
n=33 Participants
Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
|
FP/Salmeterol From Capsule-based Inhaler
n=33 Participants
Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
|
|---|---|---|
|
Mean Hemoglobin and Mean Corpuscular Hemoglobin (MCH) Concentration
Hemoglobin, 1st admin, Asthma; n=33, 33
|
138.2 Grams per liter (g/L)
Standard Deviation 12.20
|
135.4 Grams per liter (g/L)
Standard Deviation 12.32
|
|
Mean Hemoglobin and Mean Corpuscular Hemoglobin (MCH) Concentration
Hemoglobin, 2nd admin, Asthma; n=31, 33
|
133.0 Grams per liter (g/L)
Standard Deviation 14.31
|
132.3 Grams per liter (g/L)
Standard Deviation 13.44
|
|
Mean Hemoglobin and Mean Corpuscular Hemoglobin (MCH) Concentration
Hemoglobin, 1st admin, COPD; n=25, 25
|
133.3 Grams per liter (g/L)
Standard Deviation 12.07
|
133.1 Grams per liter (g/L)
Standard Deviation 11.66
|
|
Mean Hemoglobin and Mean Corpuscular Hemoglobin (MCH) Concentration
Hemoglobin, 2nd admin, COPD; n=24, 25
|
130.6 Grams per liter (g/L)
Standard Deviation 14.65
|
128.5 Grams per liter (g/L)
Standard Deviation 14.14
|
|
Mean Hemoglobin and Mean Corpuscular Hemoglobin (MCH) Concentration
MCH concentration, 1st admin, Asthma; n=33, 33
|
334.7 Grams per liter (g/L)
Standard Deviation 9.85
|
334.0 Grams per liter (g/L)
Standard Deviation 10.38
|
|
Mean Hemoglobin and Mean Corpuscular Hemoglobin (MCH) Concentration
MCH concentration, 2nd admin, Asthma; n=31, 33
|
333.0 Grams per liter (g/L)
Standard Deviation 11.21
|
333.2 Grams per liter (g/L)
Standard Deviation 10.92
|
|
Mean Hemoglobin and Mean Corpuscular Hemoglobin (MCH) Concentration
MCH concentration, 1st admin, COPD; n=,25, 25
|
329.0 Grams per liter (g/L)
Standard Deviation 9.69
|
328.5 Grams per liter (g/L)
Standard Deviation 9.37
|
|
Mean Hemoglobin and Mean Corpuscular Hemoglobin (MCH) Concentration
MCH concentration, 1st admin, COPD; n=24, 25
|
327.4 Grams per liter (g/L)
Standard Deviation 11.47
|
328.8 Grams per liter (g/L)
Standard Deviation 11.33
|
SECONDARY outcome
Timeframe: Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectivelyPopulation: All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.
Blood samples of participants were collected for the evaluation of RBC and reticulocytes count. Reticulocytes are immature red blood cells. Normally, about 1% to 2% of the red blood cells in the blood are reticulocytes. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was "ABBA," then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A.
Outcome measures
| Measure |
FP/Salmeterol From MDPI
n=33 Participants
Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
|
FP/Salmeterol From Capsule-based Inhaler
n=33 Participants
Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
|
|---|---|---|
|
Red Blood Cell (RBC) Count and Reticulocytes
RBC, 1st admin, Asthma; n=33, 33
|
4.608 Trillion (10^12) cells/L
Standard Deviation 0.3590
|
4.542 Trillion (10^12) cells/L
Standard Deviation 0.3616
|
|
Red Blood Cell (RBC) Count and Reticulocytes
RBC, 2nd admin, Asthma; n=31, 33
|
4.460 Trillion (10^12) cells/L
Standard Deviation 0.4059
|
4.424 Trillion (10^12) cells/L
Standard Deviation 0.3638
|
|
Red Blood Cell (RBC) Count and Reticulocytes
RBC, 1st admin, Asthma, COPD; n=25, 25
|
4.523 Trillion (10^12) cells/L
Standard Deviation 0.5483
|
4.530 Trillion (10^12) cells/L
Standard Deviation 0.5906
|
|
Red Blood Cell (RBC) Count and Reticulocytes
RBC, 2nd admin, COPD; n=24, 25
|
4.438 Trillion (10^12) cells/L
Standard Deviation 0.6062
|
4.358 Trillion (10^12) cells/L
Standard Deviation 0.6342
|
|
Red Blood Cell (RBC) Count and Reticulocytes
Reticulocytes, 1st admin, Asthma ; n=33, 32
|
0.049 Trillion (10^12) cells/L
Standard Deviation 0.0178
|
0.050 Trillion (10^12) cells/L
Standard Deviation 0.0168
|
|
Red Blood Cell (RBC) Count and Reticulocytes
Reticulocytes, 2nd admin, Asthma; n=31, 33
|
0.051 Trillion (10^12) cells/L
Standard Deviation 0.0195
|
0.050 Trillion (10^12) cells/L
Standard Deviation 0.0193
|
|
Red Blood Cell (RBC) Count and Reticulocytes
Reticulocytes, 1st admin, COPD; n=25, 25
|
0.054 Trillion (10^12) cells/L
Standard Deviation 0.0191
|
0.054 Trillion (10^12) cells/L
Standard Deviation 0.0230
|
|
Red Blood Cell (RBC) Count and Reticulocytes
Reticulocytes, 2nd admin, COPD; n=24, 25
|
0.059 Trillion (10^12) cells/L
Standard Deviation 0.0252
|
0.061 Trillion (10^12) cells/L
Standard Deviation 0.0271
|
SECONDARY outcome
Timeframe: Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectivelyPopulation: All Subject Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.
Blood samples of participants were collected for the evaluation of MCH. MCH is the average mass or amount of hemoglobin per red blood cell in a sample of blood. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was "ABBA," then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A.
Outcome measures
| Measure |
FP/Salmeterol From MDPI
n=33 Participants
Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
|
FP/Salmeterol From Capsule-based Inhaler
n=33 Participants
Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
|
|---|---|---|
|
Mean Corpuscule Hemoglobin (MCH)
1st admin, Asthma; n=33, 33
|
29.99 picograms (pg)/cell
Standard Deviation 1.422
|
29.86 picograms (pg)/cell
Standard Deviation 1.399
|
|
Mean Corpuscule Hemoglobin (MCH)
2nd admin, Asthma; n=31, 33
|
29.80 picograms (pg)/cell
Standard Deviation 1.501
|
29.92 picograms (pg)/cell
Standard Deviation 1.456
|
|
Mean Corpuscule Hemoglobin (MCH)
1st admin, COPD; n=25, 25
|
29.72 picograms (pg)/cell
Standard Deviation 2.920
|
29.72 picograms (pg)/cell
Standard Deviation 2.945
|
|
Mean Corpuscule Hemoglobin (MCH)
2nd admin, COPD; n=24, 25
|
29.73 picograms (pg)/cell
Standard Deviation 3.079
|
29.83 picograms (pg)/cell
Standard Deviation 2.993
|
SECONDARY outcome
Timeframe: Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectivelyPopulation: All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.
Blood samples of participants were collected for the evaluation of MCV. MCV is a measure of the average red blood cell size that is reported as part of a standard complete blood count. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was "ABBA," then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A.
Outcome measures
| Measure |
FP/Salmeterol From MDPI
n=33 Participants
Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
|
FP/Salmeterol From Capsule-based Inhaler
n=33 Participants
Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
|
|---|---|---|
|
Mean Corpuscle Volume (MCV)
1st admin, Asthma; n=33, 33
|
89.65 Femtoliters (fL; 10^-15 L)/cell
Standard Deviation 2.808
|
89.41 Femtoliters (fL; 10^-15 L)/cell
Standard Deviation 2.862
|
|
Mean Corpuscle Volume (MCV)
2nd admin, Asthma; n=31, 33
|
89.52 Femtoliters (fL; 10^-15 L)/cell
Standard Deviation 2.953
|
89.77 Femtoliters (fL; 10^-15 L)/cell
Standard Deviation 2.821
|
|
Mean Corpuscle Volume (MCV)
1st admin, COPD; n=25, 25
|
90.21 Femtoliters (fL; 10^-15 L)/cell
Standard Deviation 7.643
|
90.37 Femtoliters (fL; 10^-15 L)/cell
Standard Deviation 7.595
|
|
Mean Corpuscle Volume (MCV)
2nd admin, COPD; n=24, 25
|
90.76 Femtoliters (fL; 10^-15 L)/cell
Standard Deviation 7.609
|
90.64 Femtoliters (fL; 10^-15 L)/cell
Standard Deviation 7.498
|
SECONDARY outcome
Timeframe: Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectivelyPopulation: All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.
Blood samples of participants were collected for the evaluation of hematocrit. The hematocrit is the percentage of the RBCs in the blood. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was "ABBA," then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A.
Outcome measures
| Measure |
FP/Salmeterol From MDPI
n=33 Participants
Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
|
FP/Salmeterol From Capsule-based Inhaler
n=33 Participants
Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
|
|---|---|---|
|
Mean Hematocrit
1st admin, Asthma; n=33, 33
|
0.413 percentage of RBCs
Standard Deviation 0.0318
|
0.405 percentage of RBCs
Standard Deviation 0.0328
|
|
Mean Hematocrit
2nd admin, Asthma; n=31, 33
|
0.399 percentage of RBCs
Standard Deviation 0.0375
|
0.396 percentage of RBCs
Standard Deviation 0.0345
|
|
Mean Hematocrit
1st admin, COPD; n=25, 25
|
0.405 percentage of RBCs
Standard Deviation 0.0346
|
0.405 percentage of RBCs
Standard Deviation 0.0379
|
|
Mean Hematocrit
2nd admin, COPD; n=24, 25
|
0.400 percentage of RBCs
Standard Deviation 0.0448
|
0.391 percentage of RBCs
Standard Deviation 0.0441
|
SECONDARY outcome
Timeframe: Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectivelyPopulation: All subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.
The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was "ABBA," then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A.
Outcome measures
| Measure |
FP/Salmeterol From MDPI
n=33 Participants
Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
|
FP/Salmeterol From Capsule-based Inhaler
n=33 Participants
Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
|
|---|---|---|
|
Mean Albumin and Total Protein
Albumin, 1st admin, Asthma; n=33, 33
|
43.0 g/L
Standard Deviation 2.47
|
42.3 g/L
Standard Deviation 2.16
|
|
Mean Albumin and Total Protein
Albumin, 2nd admin, Asthma; n=31, 33
|
42.0 g/L
Standard Deviation 2.02
|
41.8 g/L
Standard Deviation 2.77
|
|
Mean Albumin and Total Protein
Albumin, 1st admin, COPD; n=25, 25
|
40.9 g/L
Standard Deviation 2.19
|
41.4 g/L
Standard Deviation 2.08
|
|
Mean Albumin and Total Protein
Albumin, 2nd admin, COPD; n=25, 25
|
40.8 g/L
Standard Deviation 2.30
|
40.0 g/L
Standard Deviation 2.12
|
|
Mean Albumin and Total Protein
Total protein, 1st admin, Asthma; n=33, 33
|
66.8 g/L
Standard Deviation 4.29
|
66.0 g/L
Standard Deviation 3.24
|
|
Mean Albumin and Total Protein
Total protein, 2nd admin, Asthma; n=31, 33
|
65.4 g/L
Standard Deviation 3.48
|
64.8 g/L
Standard Deviation 4.68
|
|
Mean Albumin and Total Protein
Total protein, 1st admin, COPD; n=25, 25
|
64.7 g/L
Standard Deviation 3.82
|
64.9 g/L
Standard Deviation 4.16
|
|
Mean Albumin and Total Protein
Total protein, 2nd admin, COPD; n=25, 25
|
64.6 g/L
Standard Deviation 4.01
|
63.5 g/L
Standard Deviation 4.00
|
SECONDARY outcome
Timeframe: Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectivelyPopulation: All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.
Blood samples of participants were collected for the evaluation of AP, ALT, AST, and GGT. All of these parameters are measured to help assess the condition of the liver. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was "ABBA," then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A.
Outcome measures
| Measure |
FP/Salmeterol From MDPI
n=33 Participants
Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
|
FP/Salmeterol From Capsule-based Inhaler
n=33 Participants
Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
|
|---|---|---|
|
Mean Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amio Transferase (AST), and Gama Glutamyl Transferase (GGT)
AST, 2nd admin, Asthma; n=31, 33
|
20.7 International units per liter (IU/L)
Standard Deviation 5.85
|
20.1 International units per liter (IU/L)
Standard Deviation 4.87
|
|
Mean Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amio Transferase (AST), and Gama Glutamyl Transferase (GGT)
AST, 1st admin, COPD; n=25, 25
|
22.7 International units per liter (IU/L)
Standard Deviation 7.44
|
24.7 International units per liter (IU/L)
Standard Deviation 14.22
|
|
Mean Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amio Transferase (AST), and Gama Glutamyl Transferase (GGT)
AP, 1st admin, Asthma; n=33, 33
|
64.6 International units per liter (IU/L)
Standard Deviation 15.00
|
63.4 International units per liter (IU/L)
Standard Deviation 14.30
|
|
Mean Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amio Transferase (AST), and Gama Glutamyl Transferase (GGT)
AP, 2nd admin, Asthma; n=31, 33
|
65.0 International units per liter (IU/L)
Standard Deviation 14.87
|
63.9 International units per liter (IU/L)
Standard Deviation 15.74
|
|
Mean Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amio Transferase (AST), and Gama Glutamyl Transferase (GGT)
AP, 1st admin, COP ; n=25, 25
|
69.6 International units per liter (IU/L)
Standard Deviation 20.28
|
69.9 International units per liter (IU/L)
Standard Deviation 22.14
|
|
Mean Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amio Transferase (AST), and Gama Glutamyl Transferase (GGT)
AP, 2nd admin, COPD; n=25, 25
|
69.8 International units per liter (IU/L)
Standard Deviation 18.31
|
68.4 International units per liter (IU/L)
Standard Deviation 17.78
|
|
Mean Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amio Transferase (AST), and Gama Glutamyl Transferase (GGT)
ALT, 1st admin, Asthma; n=33, 33
|
20.1 International units per liter (IU/L)
Standard Deviation 9.49
|
20.4 International units per liter (IU/L)
Standard Deviation 8.68
|
|
Mean Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amio Transferase (AST), and Gama Glutamyl Transferase (GGT)
ALT, 2nd admin, Asthma; n=31, 33
|
21.5 International units per liter (IU/L)
Standard Deviation 11.32
|
19.1 International units per liter (IU/L)
Standard Deviation 8.21
|
|
Mean Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amio Transferase (AST), and Gama Glutamyl Transferase (GGT)
ALT, 1st admin, COPD; n=25, 25
|
21.2 International units per liter (IU/L)
Standard Deviation 10.47
|
23.4 International units per liter (IU/L)
Standard Deviation 15.45
|
|
Mean Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amio Transferase (AST), and Gama Glutamyl Transferase (GGT)
ALT, 2nd admin, COPD; n=25, 25
|
20.9 International units per liter (IU/L)
Standard Deviation 10.80
|
21.2 International units per liter (IU/L)
Standard Deviation 10.33
|
|
Mean Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amio Transferase (AST), and Gama Glutamyl Transferase (GGT)
AST, 1st admin, Asthma; n=33, 33
|
21.2 International units per liter (IU/L)
Standard Deviation 8.22
|
21.6 International units per liter (IU/L)
Standard Deviation 4.42
|
|
Mean Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amio Transferase (AST), and Gama Glutamyl Transferase (GGT)
AST, 2nd admin, COPD; n=25, 25
|
22.5 International units per liter (IU/L)
Standard Deviation 8.95
|
21.1 International units per liter (IU/L)
Standard Deviation 7.82
|
|
Mean Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amio Transferase (AST), and Gama Glutamyl Transferase (GGT)
GGT, 1st admin, Asthma; n=33, 33
|
21.3 International units per liter (IU/L)
Standard Deviation 14.51
|
21.0 International units per liter (IU/L)
Standard Deviation 15.18
|
|
Mean Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amio Transferase (AST), and Gama Glutamyl Transferase (GGT)
GGT, 2nd admin, Asthma; n=31, 33
|
22.7 International units per liter (IU/L)
Standard Deviation 19.22
|
21.0 International units per liter (IU/L)
Standard Deviation 15.06
|
|
Mean Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amio Transferase (AST), and Gama Glutamyl Transferase (GGT)
GGT, 1st admin, COPD; n=25, 25
|
36.9 International units per liter (IU/L)
Standard Deviation 53.90
|
44.0 International units per liter (IU/L)
Standard Deviation 80.65
|
|
Mean Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amio Transferase (AST), and Gama Glutamyl Transferase (GGT)
GGT, 2nd admin, COPD; n=25, 25
|
31.8 International units per liter (IU/L)
Standard Deviation 32.85
|
29.6 International units per liter (IU/L)
Standard Deviation 24.43
|
SECONDARY outcome
Timeframe: Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectivelyPopulation: All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.
Blood samples of participants were collected for the evaluation of DP, TB, creatinine, and uric acid. DB and TB are measures that help assess the condition of the liver, and creatinine and uric acid are measures that help assess the condition of the kidneys. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was "ABBA," then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A.
Outcome measures
| Measure |
FP/Salmeterol From MDPI
n=33 Participants
Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
|
FP/Salmeterol From Capsule-based Inhaler
n=33 Participants
Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
|
|---|---|---|
|
Mean Direct Bilirubin (DB), Total Bilirubin (TB), Creatinine, and Uric Acid
DB, 1st admin, Asthma; n=33, 33
|
3.2 Micromoles per liter (µmol/L)
Standard Deviation 2.83
|
2.7 Micromoles per liter (µmol/L)
Standard Deviation 1.99
|
|
Mean Direct Bilirubin (DB), Total Bilirubin (TB), Creatinine, and Uric Acid
DB, 2nd admin, Asthma; n=31, 33
|
3.0 Micromoles per liter (µmol/L)
Standard Deviation 1.47
|
2.6 Micromoles per liter (µmol/L)
Standard Deviation 1.11
|
|
Mean Direct Bilirubin (DB), Total Bilirubin (TB), Creatinine, and Uric Acid
DB, 1st admin, COPD; n=25, 25
|
2.9 Micromoles per liter (µmol/L)
Standard Deviation 0.97
|
2.8 Micromoles per liter (µmol/L)
Standard Deviation 1.05
|
|
Mean Direct Bilirubin (DB), Total Bilirubin (TB), Creatinine, and Uric Acid
DB, 2nd admin, COPD; n=25, 25
|
2.7 Micromoles per liter (µmol/L)
Standard Deviation 1.16
|
2.9 Micromoles per liter (µmol/L)
Standard Deviation 1.22
|
|
Mean Direct Bilirubin (DB), Total Bilirubin (TB), Creatinine, and Uric Acid
TB, 1st admin, Asthma; n=33, 33
|
9.5 Micromoles per liter (µmol/L)
Standard Deviation 3.58
|
9.9 Micromoles per liter (µmol/L)
Standard Deviation 5.12
|
|
Mean Direct Bilirubin (DB), Total Bilirubin (TB), Creatinine, and Uric Acid
TB, 2nd admin, Asthma; n=31, 33
|
9.9 Micromoles per liter (µmol/L)
Standard Deviation 4.48
|
8.6 Micromoles per liter (µmol/L)
Standard Deviation 3.57
|
|
Mean Direct Bilirubin (DB), Total Bilirubin (TB), Creatinine, and Uric Acid
TB, 1st admin, COPD; n=25, 25
|
8.7 Micromoles per liter (µmol/L)
Standard Deviation 2.42
|
9.4 Micromoles per liter (µmol/L)
Standard Deviation 3.67
|
|
Mean Direct Bilirubin (DB), Total Bilirubin (TB), Creatinine, and Uric Acid
TB, 2nd admin, COPD; n=25, 25
|
8.5 Micromoles per liter (µmol/L)
Standard Deviation 2.76
|
8.4 Micromoles per liter (µmol/L)
Standard Deviation 3.51
|
|
Mean Direct Bilirubin (DB), Total Bilirubin (TB), Creatinine, and Uric Acid
Creatinine, 1st admin, Asthma; n=33, 33
|
77.2 Micromoles per liter (µmol/L)
Standard Deviation 11.48
|
75.8 Micromoles per liter (µmol/L)
Standard Deviation 11.04
|
|
Mean Direct Bilirubin (DB), Total Bilirubin (TB), Creatinine, and Uric Acid
Creatinine, 2nd admin, Asthma; n=31, 33
|
76.9 Micromoles per liter (µmol/L)
Standard Deviation 10.81
|
75.2 Micromoles per liter (µmol/L)
Standard Deviation 11.39
|
|
Mean Direct Bilirubin (DB), Total Bilirubin (TB), Creatinine, and Uric Acid
Creatinine, 1st admin, COPD; n=25, 25
|
79.4 Micromoles per liter (µmol/L)
Standard Deviation 18.33
|
77.7 Micromoles per liter (µmol/L)
Standard Deviation 16.45
|
|
Mean Direct Bilirubin (DB), Total Bilirubin (TB), Creatinine, and Uric Acid
Creatinine, 2nd admin, COPD; n=25, 25
|
79.6 Micromoles per liter (µmol/L)
Standard Deviation 17.38
|
79.4 Micromoles per liter (µmol/L)
Standard Deviation 18.45
|
|
Mean Direct Bilirubin (DB), Total Bilirubin (TB), Creatinine, and Uric Acid
Uric acid, 1st admin, Asthma n=33, 33
|
328.9 Micromoles per liter (µmol/L)
Standard Deviation 73.11
|
331.5 Micromoles per liter (µmol/L)
Standard Deviation 66.84
|
|
Mean Direct Bilirubin (DB), Total Bilirubin (TB), Creatinine, and Uric Acid
Uric acid, 2nd admin, Asthma; n=31, 33
|
338.4 Micromoles per liter (µmol/L)
Standard Deviation 67.25
|
325.6 Micromoles per liter (µmol/L)
Standard Deviation 70.04
|
|
Mean Direct Bilirubin (DB), Total Bilirubin (TB), Creatinine, and Uric Acid
Uric acid, 1st admin, COPD; n=25, 25
|
354.2 Micromoles per liter (µmol/L)
Standard Deviation 60.13
|
348.3 Micromoles per liter (µmol/L)
Standard Deviation 59.25
|
|
Mean Direct Bilirubin (DB), Total Bilirubin (TB), Creatinine, and Uric Acid
Uric acid, 2nd admin, COPD; n=25, 25
|
361.7 Micromoles per liter (µmol/L)
Standard Deviation 65.96
|
352.0 Micromoles per liter (µmol/L)
Standard Deviation 64.39
|
SECONDARY outcome
Timeframe: Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectivelyPopulation: All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.
Blood samples of participants were collected for the evaluation of calcium, chloride, glucose, potassium, sodium, carbon dioxide (CO2) content/bicarbonate, and urea/BUN. All of these parameters are measured to help assess the condition of the kidneys. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was "ABBA," then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A.
Outcome measures
| Measure |
FP/Salmeterol From MDPI
n=33 Participants
Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
|
FP/Salmeterol From Capsule-based Inhaler
n=33 Participants
Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
|
|---|---|---|
|
Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)
Calcium, 2nd admin, Asthma; n=31, 33
|
2.190 µmol/L
Standard Deviation 0.0799
|
2.170 µmol/L
Standard Deviation 0.1382
|
|
Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)
Sodium, 2nd admin, Asthma; n=31, 33
|
140.1 µmol/L
Standard Deviation 2.13
|
140.4 µmol/L
Standard Deviation 1.34
|
|
Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)
Calcium, 1st admin, Asthma; n=33, 32
|
2.191 µmol/L
Standard Deviation 0.0954
|
2.178 µmol/L
Standard Deviation 0.0900
|
|
Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)
Calcium, 1st admin, COPD; n=25, 25
|
2.205 µmol/L
Standard Deviation 0.0874
|
2.189 µmol/L
Standard Deviation 0.0946
|
|
Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)
Calcium, 2nd admin, COPD; n=25, 25
|
2.206 µmol/L
Standard Deviation 0.0998
|
2.190 µmol/L
Standard Deviation 0.0916
|
|
Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)
Chloride, 1st admin, Asthma; n=33, 33
|
104.7 µmol/L
Standard Deviation 2.38
|
104.8 µmol/L
Standard Deviation 2.28
|
|
Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)
Chloride, 2nd admin, Asthma; n=31, 33
|
104.5 µmol/L
Standard Deviation 2.29
|
105.3 µmol/L
Standard Deviation 2.89
|
|
Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)
Chloride, 1st admin, COP; n=25, 25
|
104.4 µmol/L
Standard Deviation 2.80
|
104.0 µmol/L
Standard Deviation 2.67
|
|
Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)
Chloride, 2nd admin, COPD n=25, 25
|
104.1 µmol/L
Standard Deviation 2.49
|
104.4 µmol/L
Standard Deviation 2.90
|
|
Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)
Glucose, 1st admin, Asthma; n=33, 33
|
5.06 µmol/L
Standard Deviation 0.555
|
5.06 µmol/L
Standard Deviation 0.445
|
|
Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)
Glucose, 2nd admin, Asthma; n=31, 33
|
5.06 µmol/L
Standard Deviation 0.325
|
5.15 µmol/L
Standard Deviation 0.484
|
|
Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)
Glucose, 1st admin, COPD; n=25, 25
|
5.36 µmol/L
Standard Deviation 0.846
|
5.37 µmol/L
Standard Deviation 1.306
|
|
Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)
Glucose, 2nd admin, COPD; n=25, 25
|
5.63 µmol/L
Standard Deviation 1.143
|
5.45 µmol/L
Standard Deviation 0.856
|
|
Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)
Potassium, 1st admin, Asthma; n=32, 33
|
4.15 µmol/L
Standard Deviation 0.421
|
4.05 µmol/L
Standard Deviation 0.271
|
|
Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)
Potassium, 2nd admin, Asthma; n=31, 33
|
4.06 µmol/L
Standard Deviation 0.291
|
4.02 µmol/L
Standard Deviation 0.269
|
|
Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)
Potassium, 1st admin, COPD n=25, 25
|
4.16 µmol/L
Standard Deviation 0.212
|
4.08 µmol/L
Standard Deviation 0.233
|
|
Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)
Potassium, 2nd admin, COPD; n=25, 25
|
4.10 µmol/L
Standard Deviation 0.223
|
4.11 µmol/L
Standard Deviation 0.272
|
|
Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)
Sodium, 1st admin, Asthma; n=33, 33
|
140.5 µmol/L
Standard Deviation 1.80
|
140.5 µmol/L
Standard Deviation 1.60
|
|
Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)
Sodium, 1st admin, COPD n=25, 25
|
140.5 µmol/L
Standard Deviation 2.69
|
140.5 µmol/L
Standard Deviation 2.96
|
|
Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)
Sodium, 2nd admin, COPD n=25, 25
|
140.1 µmol/L
Standard Deviation 2.49
|
140.2 µmol/L
Standard Deviation 2.59
|
|
Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)
CO2 content/bicar, 1st admin, Asthma; n=33, 33
|
26.1 µmol/L
Standard Deviation 2.09
|
25.6 µmol/L
Standard Deviation 2.26
|
|
Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)
CO2 content/bicar, 2nd admin, Asthma; n=31, 33
|
26.2 µmol/L
Standard Deviation 2.22
|
26.0 µmol/L
Standard Deviation 2.58
|
|
Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)
CO2 content/bicar, 1st admin, COPD; n=25, 25
|
27.2 µmol/L
Standard Deviation 1.90
|
27.3 µmol/L
Standard Deviation 1.89
|
|
Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)
CO2 content/bicar, 2nd admin, COPD; n=25, 25
|
27.3 µmol/L
Standard Deviation 2.08
|
27.2 µmol/L
Standard Deviation 1.89
|
|
Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)
Urea/BUN, 1st admin, Asthma; n=33, 33
|
5.34 µmol/L
Standard Deviation 1.389
|
5.41 µmol/L
Standard Deviation 1.406
|
|
Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)
Urea/BUN, 2nd admin, Asthma; n=31, 33
|
5.31 µmol/L
Standard Deviation 1.290
|
5.43 µmol/L
Standard Deviation 1.312
|
|
Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)
Urea/BUN, 1st admin, COPD; n=25, 25
|
5.98 µmol/L
Standard Deviation 1.426
|
6.09 µmol/L
Standard Deviation 1.473
|
|
Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)
Urea/BUN, 2nd admin, COPD; n=25, 25
|
5.90 µmol/L
Standard Deviation 1.402
|
6.12 µmol/L
Standard Deviation 1.446
|
SECONDARY outcome
Timeframe: Randomization (Day 1) up to Follow-up (Days 47-50)Population: All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Outcome measures
| Measure |
FP/Salmeterol From MDPI
n=33 Participants
Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
|
FP/Salmeterol From Capsule-based Inhaler
n=34 Participants
Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
|
|---|---|---|
|
Number of Participants With an Adverse Event (AE)
2nd admin, Asthma; n=31, 33
|
12 participants
|
15 participants
|
|
Number of Participants With an Adverse Event (AE)
1st admin, COPD; n=26, 25
|
14 participants
|
11 participants
|
|
Number of Participants With an Adverse Event (AE)
1st admin, Asthma; n=33, 34
|
13 participants
|
13 participants
|
|
Number of Participants With an Adverse Event (AE)
2nd admin, COPD; n=25, 25
|
9 participants
|
11 participants
|
Adverse Events
FP/Salmeterol From MDPI 1st Administration (Admin), Asthma
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
FP/Salmeterol From MDPI 2nd Admin, Asthma
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
FP/Salmeterol From Capsule-based Inhaler 1st Admin, Asthma
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
FP/Salmeterol From Capsule-based Inhaler 2nd Admin, Asthma
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
FP/Salmeterol From MDPI 1st Admin, COPD
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
FP/Salmeterol From MDPI 2nd Admin, COPD
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
FP/Salmeterol From Capsule-based Inhaler 1st Admin, COPD
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
FP/Salmeterol From Capsule-based Inhaler 2nd Admin, COPD
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FP/Salmeterol From MDPI 1st Administration (Admin), Asthma
n=33 participants at risk
Fluticasone propionate (FP)/salmeterol combination was administered to participants with asthma as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for a 10-day period.
|
FP/Salmeterol From MDPI 2nd Admin, Asthma
n=31 participants at risk
Fluticasone propionate (FP)/salmeterol combination was administered to particiapants with asthma as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for a 10-day period.
|
FP/Salmeterol From Capsule-based Inhaler 1st Admin, Asthma
n=34 participants at risk
Fluticasone propionate (FP)/salmeterol combination was administered to participants with asthma as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for a 10-day period.
|
FP/Salmeterol From Capsule-based Inhaler 2nd Admin, Asthma
n=33 participants at risk
Fluticasone propionate (FP)/salmeterol combination was administered to participants with asthma as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for a 10-day period.
|
FP/Salmeterol From MDPI 1st Admin, COPD
n=26 participants at risk
Fluticasone propionate (FP)/salmeterol combination was administered to participants with COPD as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for a 10-day period.
|
FP/Salmeterol From MDPI 2nd Admin, COPD
n=25 participants at risk
Fluticasone propionate (FP)/salmeterol combination was administered to participants with COPD as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for a 10-day period.
|
FP/Salmeterol From Capsule-based Inhaler 1st Admin, COPD
n=25 participants at risk
Fluticasone propionate (FP)/salmeterol combination was administered to participants with COPD as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for a 10-day period.
|
FP/Salmeterol From Capsule-based Inhaler 2nd Admin, COPD
n=25 participants at risk
Fluticasone propionate (FP)/salmeterol combination was administered to participants with COPD as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for a 10-day period.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
Other adverse events
| Measure |
FP/Salmeterol From MDPI 1st Administration (Admin), Asthma
n=33 participants at risk
Fluticasone propionate (FP)/salmeterol combination was administered to participants with asthma as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for a 10-day period.
|
FP/Salmeterol From MDPI 2nd Admin, Asthma
n=31 participants at risk
Fluticasone propionate (FP)/salmeterol combination was administered to particiapants with asthma as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for a 10-day period.
|
FP/Salmeterol From Capsule-based Inhaler 1st Admin, Asthma
n=34 participants at risk
Fluticasone propionate (FP)/salmeterol combination was administered to participants with asthma as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for a 10-day period.
|
FP/Salmeterol From Capsule-based Inhaler 2nd Admin, Asthma
n=33 participants at risk
Fluticasone propionate (FP)/salmeterol combination was administered to participants with asthma as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for a 10-day period.
|
FP/Salmeterol From MDPI 1st Admin, COPD
n=26 participants at risk
Fluticasone propionate (FP)/salmeterol combination was administered to participants with COPD as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for a 10-day period.
|
FP/Salmeterol From MDPI 2nd Admin, COPD
n=25 participants at risk
Fluticasone propionate (FP)/salmeterol combination was administered to participants with COPD as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for a 10-day period.
|
FP/Salmeterol From Capsule-based Inhaler 1st Admin, COPD
n=25 participants at risk
Fluticasone propionate (FP)/salmeterol combination was administered to participants with COPD as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for a 10-day period.
|
FP/Salmeterol From Capsule-based Inhaler 2nd Admin, COPD
n=25 participants at risk
Fluticasone propionate (FP)/salmeterol combination was administered to participants with COPD as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for a 10-day period.
|
|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
24.2%
8/33
|
22.6%
7/31
|
29.4%
10/34
|
30.3%
10/33
|
19.2%
5/26
|
20.0%
5/25
|
8.0%
2/25
|
12.0%
3/25
|
|
Nervous system disorders
Migraine
|
0.00%
0/33
|
3.2%
1/31
|
2.9%
1/34
|
0.00%
0/33
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Nervous system disorders
Presyncope
|
3.0%
1/33
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
0.00%
0/26
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
|
Nervous system disorders
Dizziness
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
7.7%
2/26
|
0.00%
0/25
|
0.00%
0/25
|
4.0%
1/25
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
3.8%
1/26
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
0.00%
0/26
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
|
Infections and infestations
Nasopharyngitis
|
3.0%
1/33
|
0.00%
0/31
|
0.00%
0/34
|
6.1%
2/33
|
0.00%
0/26
|
0.00%
0/25
|
4.0%
1/25
|
4.0%
1/25
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/33
|
3.2%
1/31
|
0.00%
0/34
|
3.0%
1/33
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Infections and infestations
Viral upper respiratory tract infection
|
6.1%
2/33
|
3.2%
1/31
|
0.00%
0/34
|
0.00%
0/33
|
3.8%
1/26
|
8.0%
2/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Infections and infestations
Sinusitis
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33
|
3.8%
1/26
|
0.00%
0/25
|
4.0%
1/25
|
4.0%
1/25
|
|
Infections and infestations
Vaginal infection
|
3.0%
1/33
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Infections and infestations
Viral infection
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34
|
0.00%
0/33
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
0.00%
0/26
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/25
|
4.0%
1/25
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
3.8%
1/26
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
0.00%
0/26
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.1%
2/33
|
0.00%
0/31
|
2.9%
1/34
|
0.00%
0/33
|
7.7%
2/26
|
0.00%
0/25
|
4.0%
1/25
|
4.0%
1/25
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34
|
3.0%
1/33
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/33
|
3.2%
1/31
|
0.00%
0/34
|
0.00%
0/33
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.0%
1/33
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
3.8%
1/26
|
0.00%
0/25
|
4.0%
1/25
|
8.0%
2/25
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/33
|
3.2%
1/31
|
0.00%
0/34
|
0.00%
0/33
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
3.8%
1/26
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
3.8%
1/26
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
0.00%
0/26
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/33
|
6.5%
2/31
|
0.00%
0/34
|
0.00%
0/33
|
0.00%
0/26
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34
|
0.00%
0/33
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.0%
1/33
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
3.8%
1/26
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/25
|
4.0%
1/25
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/25
|
4.0%
1/25
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/25
|
4.0%
1/25
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
1/33
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
7.7%
2/26
|
0.00%
0/25
|
0.00%
0/25
|
4.0%
1/25
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/33
|
3.2%
1/31
|
0.00%
0/34
|
0.00%
0/33
|
3.8%
1/26
|
4.0%
1/25
|
4.0%
1/25
|
4.0%
1/25
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33
|
0.00%
0/26
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.0%
1/33
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
0.00%
0/26
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Cardiac disorders
Palpitations
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34
|
0.00%
0/33
|
3.8%
1/26
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Immune system disorders
Seasonal allergy
|
3.0%
1/33
|
6.5%
2/31
|
0.00%
0/34
|
0.00%
0/33
|
0.00%
0/26
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
0.00%
0/26
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34
|
0.00%
0/33
|
0.00%
0/26
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
|
Metabolism and nutrition disorders
Food intolerance
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
3.0%
1/33
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
3.8%
1/26
|
0.00%
0/25
|
0.00%
0/25
|
4.0%
1/25
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/33
|
0.00%
0/31
|
2.9%
1/34
|
0.00%
0/33
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
|
General disorders
Fatigue
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
3.8%
1/26
|
4.0%
1/25
|
4.0%
1/25
|
0.00%
0/25
|
|
General disorders
Malaise
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/25
|
4.0%
1/25
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
0.00%
0/26
|
0.00%
0/25
|
0.00%
0/25
|
4.0%
1/25
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/33
|
0.00%
0/31
|
0.00%
0/34
|
0.00%
0/33
|
0.00%
0/26
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER