Trial Outcomes & Findings for A Study to Characterize Pharmacokinetics of Tiotropium + Olodaterol Fixed-dose Combination in Japanese Patients With COPD. (NCT NCT01703845)
NCT ID: NCT01703845
Last Updated: 2015-07-15
Results Overview
Maximum measured concentration of olodaterol after multiple inhaled administration of tiotropium+olodaterol in plasma at steady state (Cmax,ss). Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type.
COMPLETED
PHASE1
32 participants
15 minutes (min) pre-dose and 5, 10, 20, 40 min, 1, 2, 3, and 4 hours (h) following drug administration on day 21
2015-07-15
Participant Flow
This is a randomised, open-label, parallel group trial in which 3 weeks of randomised treatment are preceded by 2-week screening period and followed by 3-week follow-up period.
Participant milestones
| Measure |
Tiotropium + Olodaterol (5µg/5µg)
Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
Tiotropium + Olodaterol (2.5µg/5µg)
Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
13
|
16
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Tiotropium + Olodaterol (5µg/5µg)
Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
Tiotropium + Olodaterol (2.5µg/5µg)
Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
other than stated above
|
1
|
0
|
Baseline Characteristics
A Study to Characterize Pharmacokinetics of Tiotropium + Olodaterol Fixed-dose Combination in Japanese Patients With COPD.
Baseline characteristics by cohort
| Measure |
Tiotropium + Olodaterol (5µg/5µg)
n=16 Participants
Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
Tiotropium + Olodaterol (2.5µg/5µg)
n=16 Participants
Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
69.4 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
66.4 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 minutes (min) pre-dose and 5, 10, 20, 40 min, 1, 2, 3, and 4 hours (h) following drug administration on day 21Population: The Pharmacokinetic (PK) set was defined as all treated patients who have at least 1 PK parameter in the treatment period without PK related important protocol violations. Two patients prematurely stopped the trial medication and had no PK measurement at Visit 3 (day 21) and were excluded from the PK set. Thus, the PK set included 30 patients.
Maximum measured concentration of olodaterol after multiple inhaled administration of tiotropium+olodaterol in plasma at steady state (Cmax,ss). Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type.
Outcome measures
| Measure |
Tiotropium + Olodaterol (5µg/5µg)
n=13 Participants
Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
Tiotropium + Olodaterol (2.5µg/5µg)
n=15 Participants
Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
|---|---|---|
|
Cmax,ss (Olodaterol)
|
4.33 picogram/milliliter (pg/mL)
Geometric Coefficient of Variation 53.7
|
2.82 picogram/milliliter (pg/mL)
Geometric Coefficient of Variation 106
|
PRIMARY outcome
Timeframe: 15 min pre-dose and 5, 10, 20, 40 min, 1, 2, 3, and 4 h following drug administration on day 21Population: The Pharmacokinetic (PK) set.
Area under the concentration-time curve of olodaterol in plasma after multiple inhaled administration of tiotropium+olodaterol over the time interval 0 to 4 hours at steady state (AUCt1-t2,ss). Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type.
Outcome measures
| Measure |
Tiotropium + Olodaterol (5µg/5µg)
n=12 Participants
Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
Tiotropium + Olodaterol (2.5µg/5µg)
n=13 Participants
Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
|---|---|---|
|
AUCt1-t2,ss (Olodaterol)
|
9.94 pg*h/mL
Geometric Coefficient of Variation 29.9
|
8.14 pg*h/mL
Geometric Coefficient of Variation 65.5
|
PRIMARY outcome
Timeframe: 15 min pre-dose and 5, 10, 20, 40 min, 1, 2, 3, and 4 h following drug administration on day 21Population: The Pharmacokinetic (PK) set.
Area under the concentration-time curve of olodaterol after multiple inhaled administration of tiotropium+olodaterol in plasma over the time interval from 0 to the time of the last quantifiable data point at steady state (AUC0-tz,ss). Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type.
Outcome measures
| Measure |
Tiotropium + Olodaterol (5µg/5µg)
n=12 Participants
Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
Tiotropium + Olodaterol (2.5µg/5µg)
n=14 Participants
Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
|---|---|---|
|
AUC0-tz,ss (Olodaterol)
|
9.94 pg*h/mL
Geometric Coefficient of Variation 29.9
|
6.85 pg*h/mL
Geometric Coefficient of Variation 105
|
PRIMARY outcome
Timeframe: 15 min pre-dose and 5, 10, 20, 40 min, 1, 2, 3 and 4 hours (h) following drug administration on day 21Population: The Pharmacokinetic (PK) set.
Time from dosing to the maximum concentration of Olodaterol after multiple inhaled administration of tiotropium+olodaterol in plasma at steady state (tmax,ss). Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type.
Outcome measures
| Measure |
Tiotropium + Olodaterol (5µg/5µg)
n=13 Participants
Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
Tiotropium + Olodaterol (2.5µg/5µg)
n=15 Participants
Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
|---|---|---|
|
Tmax,ss (Olodaterol)
|
0.183 h
Interval 0.1 to 0.333
|
0.217 h
Interval 0.1 to 2.0
|
PRIMARY outcome
Timeframe: from 0 to 4 hours following drug administration on day 21Population: The Pharmacokinetic (PK) set.
Amount of olodaterol that is eliminated in urine after multiple inhaled administration of tiotropium+olodaterol over the time interval 0 to 4 hours at steady state (Aet1-t2,ss). Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type.
Outcome measures
| Measure |
Tiotropium + Olodaterol (5µg/5µg)
n=13 Participants
Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
Tiotropium + Olodaterol (2.5µg/5µg)
n=16 Participants
Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
|---|---|---|
|
Aet1-t2,ss (Olodaterol)
|
74.8 nanogram (ng)
Geometric Coefficient of Variation 100
|
50.0 nanogram (ng)
Geometric Coefficient of Variation 123
|
PRIMARY outcome
Timeframe: from 0 to 4 hours following drug administration on day 21Population: The Pharmacokinetic (PK) set.
Fraction eliminated in urine from the time point t1 (0 h) to time point t2 (4 h) at steady state (fet1-t2,ss). Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type.
Outcome measures
| Measure |
Tiotropium + Olodaterol (5µg/5µg)
n=13 Participants
Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
Tiotropium + Olodaterol (2.5µg/5µg)
n=16 Participants
Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
|---|---|---|
|
fe t1-t2,ss (Olodaterol)
|
1.50 percentage of dose
Geometric Coefficient of Variation 100
|
0.999 percentage of dose
Geometric Coefficient of Variation 123
|
PRIMARY outcome
Timeframe: from 0 to 4 hours following drug administration on day 21Population: The Pharmacokinetic (PK) set.
Renal clearance from the time point t1 (0 h) until the time point t2 (4 h) at steady state (CLR,t1-t2,ss). Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type.
Outcome measures
| Measure |
Tiotropium + Olodaterol (5µg/5µg)
n=12 Participants
Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
Tiotropium + Olodaterol (2.5µg/5µg)
n=13 Participants
Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
|---|---|---|
|
CLR,t1-t2,ss (Olodaterol)
|
152 mL/min
Geometric Coefficient of Variation 48.7
|
148 mL/min
Geometric Coefficient of Variation 42.8
|
PRIMARY outcome
Timeframe: 15 minutes (min) pre-dose and 5, 10, 20, 40 min, 1, 2, 3, and 4 hours (h) following drug administration on day 21Population: The Pharmacokinetic (PK) set.
Maximum measured concentration of tiotropium after multiple inhaled administration of tiotropium+olodaterol in plasma at steady state (Cmax,ss). Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type.
Outcome measures
| Measure |
Tiotropium + Olodaterol (5µg/5µg)
n=13 Participants
Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
Tiotropium + Olodaterol (2.5µg/5µg)
n=14 Participants
Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
|---|---|---|
|
Cmax,ss (Tiotropium)
|
16.5 picogram/milliliter (pg/mL)
Geometric Coefficient of Variation 92.0
|
6.49 picogram/milliliter (pg/mL)
Geometric Coefficient of Variation 50.4
|
PRIMARY outcome
Timeframe: 15 min pre-dose and 5, 10, 20, 40 min, 1 and 2 h following drug administration on day 21Population: The Pharmacokinetic (PK) set.
Area under the concentration-time curve of tiotropium in plasma after multiple inhaled administration of tiotropium+olodaterol over the time interval 0 to 2 hours at steady state (AUCt1-t2,ss). Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type.
Outcome measures
| Measure |
Tiotropium + Olodaterol (5µg/5µg)
n=12 Participants
Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
Tiotropium + Olodaterol (2.5µg/5µg)
n=11 Participants
Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
|---|---|---|
|
AUCt1-t2,ss (Tiotropium)
|
14.8 pg*h/mL
Geometric Coefficient of Variation 50.7
|
7.00 pg*h/mL
Geometric Coefficient of Variation 52.8
|
PRIMARY outcome
Timeframe: 15 min pre-dose and 5, 10, 20, 40 min, 1, 2, 3, and 4 h following drug administration on day 21Population: The Pharmacokinetic (PK) set.
Area under the concentration-time curve of tiotropium after multiple inhaled administration of tiotropium+olodaterol in plasma over the time interval from 0 to the time of the last quantifiable data point at steady state (AUC0-tz,ss). Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type.
Outcome measures
| Measure |
Tiotropium + Olodaterol (5µg/5µg)
n=12 Participants
Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
Tiotropium + Olodaterol (2.5µg/5µg)
n=13 Participants
Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
|---|---|---|
|
AUC0-tz,ss (Tiotropium)
|
23.3 pg*h/mL
Geometric Coefficient of Variation 44.8
|
7.99 pg*h/mL
Geometric Coefficient of Variation 131
|
PRIMARY outcome
Timeframe: 15 min pre-dose and 5, 10, 20, 40 min, 1, 2, 3, 4 hours following drug administration on day 21Population: The Pharmacokinetic (PK) set.
Time from dosing to the maximum concentration of tiotropium after multiple inhaled administration of tiotropium+olodaterol in plasma at steady state (tmax,ss). Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type.
Outcome measures
| Measure |
Tiotropium + Olodaterol (5µg/5µg)
n=13 Participants
Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
Tiotropium + Olodaterol (2.5µg/5µg)
n=14 Participants
Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
|---|---|---|
|
Tmax,ss (Tiotropium)
|
0.100 h
Interval 0.1 to 0.333
|
0.100 h
Interval 0.083 to 0.183
|
PRIMARY outcome
Timeframe: from 0 to 4 hours following drug administration on day 21Population: The Pharmacokinetic (PK) set.
Amount of tiotropium that is eliminated in urine after multiple inhaled administration of tiotropium+olodaterol over the time interval 0 to 4 hours at steady state (Aet1-t2,ss). Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type.
Outcome measures
| Measure |
Tiotropium + Olodaterol (5µg/5µg)
n=13 Participants
Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
Tiotropium + Olodaterol (2.5µg/5µg)
n=16 Participants
Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
|---|---|---|
|
Aet1-t2,ss (Tiotropium)
|
336 nanogram (ng)
Geometric Coefficient of Variation 119
|
122 nanogram (ng)
Geometric Coefficient of Variation 118
|
PRIMARY outcome
Timeframe: from 0 to 4 hours following drug administration on day 21Population: The Pharmacokinetic (PK) set.
Fraction eliminated in urine from the time point t1 (0 h) to time point t2 (4 h) at steady state (fet1-t2,ss). Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type.
Outcome measures
| Measure |
Tiotropium + Olodaterol (5µg/5µg)
n=13 Participants
Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
Tiotropium + Olodaterol (2.5µg/5µg)
n=16 Participants
Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
|---|---|---|
|
fe t1-t2,ss (Tiotropium)
|
6.72 percentage of dose
Geometric Coefficient of Variation 119
|
4.89 percentage of dose
Geometric Coefficient of Variation 118
|
PRIMARY outcome
Timeframe: from 0 to 4 hours following drug administration on day 21Population: The Pharmacokinetic (PK) set.
Renal clearance from the time point t1 (0 h) until the time point t2 (4 h) at steady state (CLR,t1-t2,ss). Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type. Plasma concentration of tiotropium could not be quantified up to 4 hours for Tiotropium + Olodaterol (2.5μg/5μg).
Outcome measures
| Measure |
Tiotropium + Olodaterol (5µg/5µg)
n=12 Participants
Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
Tiotropium + Olodaterol (2.5µg/5µg)
Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
|---|---|---|
|
CLR,t1-t2,ss (Tiotropium)
|
292 mL/min
Geometric Coefficient of Variation 44.6
|
—
|
SECONDARY outcome
Timeframe: up to 6 weeks (3 weeks treatment and 3 weeks follow-up) post dosePopulation: Treated Set (TS) includes all randomised patients who received at least one dose of trial medication.
Outcome data show are the number of patients with an adverse event including the assessment based on physical examination.
Outcome measures
| Measure |
Tiotropium + Olodaterol (5µg/5µg)
n=16 Participants
Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
Tiotropium + Olodaterol (2.5µg/5µg)
n=16 Participants
Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
|---|---|---|
|
Number of Participants With Adverse Events (Including Assessment Based on Physical Examination)
|
4 participants
|
2 participants
|
SECONDARY outcome
Timeframe: up to 6 weeks (3 weeks treatment and 3 weeks follow-up) post dosePopulation: The treated Set (TS).
Outcome data show are the number of participants with clinically relevant abnormalities reported as an adverse event (AE) related to the vital signs (pulse rate and blood pressure in supine position), clinical laboratory (routine blood chemistry, haematology, and urinalysis) tests and ECG (12-lead holter monitoring Electrocardiography). Relevant findings or worsening of baseline conditions were reported as adverse events. There were no clinically relevant abnormalities reported as an AE related to the vital signs and ECG.
Outcome measures
| Measure |
Tiotropium + Olodaterol (5µg/5µg)
n=16 Participants
Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
Tiotropium + Olodaterol (2.5µg/5µg)
n=16 Participants
Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
|---|---|---|
|
Number of Participants With Clinically Relevant Abnormalities in Vital Signs, Clinical Laboratory Tests and ECG
AEs reported related to vital signs
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Relevant Abnormalities in Vital Signs, Clinical Laboratory Tests and ECG
AEs reported related to ECG
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Relevant Abnormalities in Vital Signs, Clinical Laboratory Tests and ECG
Haematuria
|
0 participants
|
1 participants
|
|
Number of Participants With Clinically Relevant Abnormalities in Vital Signs, Clinical Laboratory Tests and ECG
Blood creatine phosphokinase increased
|
1 participants
|
0 participants
|
|
Number of Participants With Clinically Relevant Abnormalities in Vital Signs, Clinical Laboratory Tests and ECG
Blood urine present
|
1 participants
|
0 participants
|
Adverse Events
Tiotropium + Olodaterol (5µg/5µg)
Tiotropium + Olodaterol (2.5µg/5µg)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tiotropium + Olodaterol (5µg/5µg)
n=16 participants at risk
Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
Tiotropium + Olodaterol (2.5µg/5µg)
n=16 participants at risk
Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
6.2%
1/16 • up to 44 days (23 days maximum number of days a study treatment was used after first intake and 21 days follow-up)
|
0.00%
0/16 • up to 44 days (23 days maximum number of days a study treatment was used after first intake and 21 days follow-up)
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
1/16 • up to 44 days (23 days maximum number of days a study treatment was used after first intake and 21 days follow-up)
|
6.2%
1/16 • up to 44 days (23 days maximum number of days a study treatment was used after first intake and 21 days follow-up)
|
|
Investigations
Blood creatine phosphokinase increased
|
6.2%
1/16 • up to 44 days (23 days maximum number of days a study treatment was used after first intake and 21 days follow-up)
|
0.00%
0/16 • up to 44 days (23 days maximum number of days a study treatment was used after first intake and 21 days follow-up)
|
|
Investigations
Blood urine present
|
6.2%
1/16 • up to 44 days (23 days maximum number of days a study treatment was used after first intake and 21 days follow-up)
|
0.00%
0/16 • up to 44 days (23 days maximum number of days a study treatment was used after first intake and 21 days follow-up)
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • up to 44 days (23 days maximum number of days a study treatment was used after first intake and 21 days follow-up)
|
0.00%
0/16 • up to 44 days (23 days maximum number of days a study treatment was used after first intake and 21 days follow-up)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/16 • up to 44 days (23 days maximum number of days a study treatment was used after first intake and 21 days follow-up)
|
6.2%
1/16 • up to 44 days (23 days maximum number of days a study treatment was used after first intake and 21 days follow-up)
|
Additional Information
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Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER