Trial Outcomes & Findings for A Study to Assess Drug Absorption of Fixed Dose Combinations of Budesonide, Glycopyrronium, and Formoterol (NCT NCT04600505)
NCT ID: NCT04600505
Last Updated: 2023-01-23
Results Overview
Evaluation of the relative bioavailability between the test formulations and the reference formulation for fixed dose combinations (FDCs) of BGF when delivered as BGF MDI with 3 different propellants by Cmax.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
47 participants
Primary outcome timeframe
Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose and 1, 2, 4, 8, 12 and 24 hours post-dose
Results posted on
2023-01-23
Participant Flow
This study was conducted between 19 Oct 2020 to 17 May 2021 at a single study center - Parexel Early Phase Clinical Unit (Los Angeles).
This study consisted of a Screening Period of 28 days. There were three treatment periods of maximum three days each, with washout period of 3 to 7 days between each study dose administration. The assessments were done as per the schedule of assessment in the clinical study protocol.
Participant milestones
| Measure |
Treatment Sequence ABC
Randomized participants received 3 single-dose treatments of budesonide, glycopyronnium, formoterol (BGF) metered dose inhaler (MDI) (1 dose Propellant 1 \[Treatment A\]; 1 dose Propellant 2 \[Treatment B\] and 1 dose HFA propellant \[Treatment C\]) in 3 treatment periods, with wash-out periods of 3 - 7 days between each study dose administration under fasted conditions.
|
Treatment Sequence BCA
Randomized participants received 3 single-dose treatments of BGF MDI (1 dose Propellant 2 \[Treatment B\]; 1 dose HFA propellant \[Treatment C\] and 1 dose Propellant 1 \[Treatment A\]) in 3 treatment periods, with wash-out periods of 3 - 7 days between each study dose administration under fasted conditions.
|
Treatment Sequence CAB
Randomized participants received 3 single-dose treatments of BGF MDI (1 dose HFA propellant \[Treatment C\]; 1 dose Propellant 1 \[Treatment A\] and 1 dose Propellant 2 \[Treatment B\]) in 3 treatment periods, with wash-out periods of 3 - 7 days between each study dose administration under fasted conditions.
|
Treatment Sequence ACB
Randomized participants received 3 single-dose treatments of BGF MDI (1 dose Propellant 1 \[Treatment A\]; 1 dose HFA propellant \[Treatment C\] and 1 dose Propellant 2 \[Treatment B\]) in 3 treatment periods, with wash-out periods of 3 - 7 days between each study dose administration under fasted conditions.
|
Treatment Sequence BAC
Randomized participants received 3 single-dose treatments of BGF MDI (1 dose Propellant 2 \[Treatment B\]; 1 dose Propellant 1 \[Treatment A\] and 1 dose HFA propellant \[Treatment C\]) in 3 treatment periods, with wash-out periods of 3 - 7 days between each study dose administration under fasted conditions.
|
Treatment Sequence CBA
Randomized participants received 3 single-dose treatments of BGF MDI (1 dose HFA propellant \[Treatment C\]; 1 dose Propellant 2 \[Treatment B\] and 1 dose Propellant 1 \[Treatment A\]) in 3 treatment periods, with wash-out periods of 3 - 7 days between each study dose administration under fasted conditions.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
7
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
8
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess Drug Absorption of Fixed Dose Combinations of Budesonide, Glycopyrronium, and Formoterol
Baseline characteristics by cohort
| Measure |
Treatment Sequence ABC
n=8 Participants
Randomized participants received 3 single-dose treatments of BGF MDI (1 dose Propellant 1 \[Treatment A\]; 1 dose Propellant 2 \[Treatment B\] and 1 dose HFA propellant \[Treatment C\]) in 3 treatment periods, with wash-out periods of 3 - 7 days between each study dose administration under fasted conditions.
|
Treatment Sequence BCA
n=8 Participants
Randomized participants received 3 single-dose treatments of BGF MDI (1 dose Propellant 2 \[Treatment B\]; 1 dose HFA propellant \[Treatment C\] and 1 dose Propellant 1 \[Treatment A\]) in 3 treatment periods, with wash-out periods of 3 - 7 days between each study dose administration under fasted conditions.
|
Treatment Sequence CAB
n=8 Participants
Randomized participants received 3 single-dose treatments of BGF MDI (1 dose HFA propellant \[Treatment C\]; 1 dose Propellant 1 \[Treatment A\] and 1 dose Propellant 2 \[Treatment B\]) in 3 treatment periods, with wash-out periods of 3 - 7 days between each study dose administration under fasted conditions.
|
Treatment Sequence ACB
n=8 Participants
Randomized participants received 3 single-dose treatments of BGF MDI (1 dose Propellant 1 \[Treatment A\]; 1 dose HFA propellant \[Treatment C\] and 1 dose Propellant 2 \[Treatment B\]) in 3 treatment periods, with wash-out periods of 3 - 7 days between each study dose administration under fasted conditions.
|
Treatment Sequence BAC
n=7 Participants
Randomized participants received 3 single-dose treatments of BGF MDI (1 dose Propellant 2 \[Treatment B\]; 1 dose Propellant 1 \[Treatment A\] and 1 dose HFA propellant \[Treatment C\]) in 3 treatment periods, with wash-out periods of 3 - 7 days between each study dose administration under fasted conditions.
|
Treatment Sequence CBA
n=8 Participants
Randomized participants received 3 single-dose treatments of BGF MDI (1 dose HFA propellant \[Treatment C\]; 1 dose Propellant 2 \[Treatment B\] and 1 dose Propellant 1 \[Treatment A\]) in 3 treatment periods, with wash-out periods of 3 - 7 days between each study dose administration under fasted conditions.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.0 Years
STANDARD_DEVIATION 7.56 • n=5 Participants
|
38.5 Years
STANDARD_DEVIATION 7.67 • n=7 Participants
|
36.6 Years
STANDARD_DEVIATION 6.63 • n=5 Participants
|
34.4 Years
STANDARD_DEVIATION 8.33 • n=4 Participants
|
34.7 Years
STANDARD_DEVIATION 11.63 • n=21 Participants
|
39.1 Years
STANDARD_DEVIATION 11.89 • n=8 Participants
|
36.6 Years
STANDARD_DEVIATION 8.79 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
47 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
36 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
22 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose and 1, 2, 4, 8, 12 and 24 hours post-dosePopulation: The PK Analysis Set consisted of all participants in the Safety Analysis Set for whom at least 1 of the primary PK parameters could have been calculated, and who had no important protocol deviations thought to impact on the analysis of the PK data. Number Analyzed in each row signifies only the participants with available data that were analyzed for BGF MDI.
Evaluation of the relative bioavailability between the test formulations and the reference formulation for fixed dose combinations (FDCs) of BGF when delivered as BGF MDI with 3 different propellants by Cmax.
Outcome measures
| Measure |
Treatment A
n=24 Participants
Participants received 2 inhalations of BGF MDI with Propellant 1 - test formulation (Treatment A)
|
Treatment B
n=22 Participants
Participants received 2 inhalations of BGF MDI with Propellant 2 - test formulation (Treatment B)
|
Treatment C
n=23 Participants
Participants received 2 inhalations of BGF MDI with HFA Propellant - reference formulation (Treatment C)
|
|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of BGF MDI
Budesonide
|
552.2 pg/mL
Geometric Coefficient of Variation 54.74
|
483.2 pg/mL
Geometric Coefficient of Variation 48.43
|
489.4 pg/mL
Geometric Coefficient of Variation 61.61
|
|
Maximum Observed Concentration (Cmax) of BGF MDI
Glycopyrronium
|
11.74 pg/mL
Geometric Coefficient of Variation 72.16
|
10.19 pg/mL
Geometric Coefficient of Variation 58.42
|
10.76 pg/mL
Geometric Coefficient of Variation 70.78
|
|
Maximum Observed Concentration (Cmax) of BGF MDI
Formoterol
|
12.70 pg/mL
Geometric Coefficient of Variation 50.52
|
11.68 pg/mL
Geometric Coefficient of Variation 47.22
|
11.48 pg/mL
Geometric Coefficient of Variation 52.95
|
PRIMARY outcome
Timeframe: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose and 1, 2, 4, 8, 12 and 24 hours post-dosePopulation: The PK Analysis Set consisted of all participants in the Safety Analysis Set for whom at least 1 of the primary PK parameters could have been calculated, and who had no important protocol deviations thought to impact on the analysis of the PK data. Number Analyzed in each row signifies only the participants with available data that were analyzed for BGF MDI.
Evaluation of the relative bioavailability between the test formulations and the reference formulation for FDCs of BGF when delivered as BGF MDI with 3 different propellants by AUCinf.
Outcome measures
| Measure |
Treatment A
n=24 Participants
Participants received 2 inhalations of BGF MDI with Propellant 1 - test formulation (Treatment A)
|
Treatment B
n=22 Participants
Participants received 2 inhalations of BGF MDI with Propellant 2 - test formulation (Treatment B)
|
Treatment C
n=21 Participants
Participants received 2 inhalations of BGF MDI with HFA Propellant - reference formulation (Treatment C)
|
|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of BGF MDI
Formoterol
|
93.68 h*pg/mL
Geometric Coefficient of Variation 35.71
|
115.1 h*pg/mL
Geometric Coefficient of Variation 30.99
|
92.84 h*pg/mL
Geometric Coefficient of Variation 30.45
|
|
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of BGF MDI
Budesonide
|
2454 h*pg/mL
Geometric Coefficient of Variation 36.76
|
2262 h*pg/mL
Geometric Coefficient of Variation 32.27
|
2314 h*pg/mL
Geometric Coefficient of Variation 45.60
|
|
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of BGF MDI
Glycopyrronium
|
30.32 h*pg/mL
Geometric Coefficient of Variation 39.74
|
27.23 h*pg/mL
Geometric Coefficient of Variation 30.67
|
NA h*pg/mL
Geometric Coefficient of Variation NA
Three values were required as a minimum for PK parameters to be summarized as per protocol.
|
PRIMARY outcome
Timeframe: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose and 1, 2, 4, 8, 12 and 24 hours post-dosePopulation: The PK Analysis Set consisted of all participants in the Safety Analysis Set for whom at least 1 of the primary PK parameters could have been calculated, and who had no important protocol deviations thought to impact on the analysis of the PK data. Number Analyzed in each row signifies only the participants with available data that were analyzed for BGF MDI.
Evaluation of the relative bioavailability between the test formulations and the reference formulation for FDCs of BGF when delivered as BGF MDI with 3 different propellants by AUClast.
Outcome measures
| Measure |
Treatment A
n=24 Participants
Participants received 2 inhalations of BGF MDI with Propellant 1 - test formulation (Treatment A)
|
Treatment B
n=22 Participants
Participants received 2 inhalations of BGF MDI with Propellant 2 - test formulation (Treatment B)
|
Treatment C
n=23 Participants
Participants received 2 inhalations of BGF MDI with HFA Propellant - reference formulation (Treatment C)
|
|---|---|---|---|
|
Area Under the Plasma Concentration- Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of BGF MDI
Glycopyrronium
|
29.87 h*pg/mL
Geometric Coefficient of Variation 88.09
|
28.63 h*pg/mL
Geometric Coefficient of Variation 53.90
|
29.20 h*pg/mL
Geometric Coefficient of Variation 82.24
|
|
Area Under the Plasma Concentration- Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of BGF MDI
Formoterol
|
66.17 h*pg/mL
Geometric Coefficient of Variation 50.54
|
74.34 h*pg/mL
Geometric Coefficient of Variation 41.35
|
67.82 h*pg/mL
Geometric Coefficient of Variation 55.58
|
|
Area Under the Plasma Concentration- Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of BGF MDI
Budesonide
|
2391 h*pg/mL
Geometric Coefficient of Variation 36.77
|
2197 h*pg/mL
Geometric Coefficient of Variation 32.81
|
2232 h*pg/mL
Geometric Coefficient of Variation 44.14
|
SECONDARY outcome
Timeframe: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose and 1, 2, 4, 8, 12 and 24 hours post-dosePopulation: The PK Analysis Set consisted of all participants in the Safety Analysis Set for whom at least 1 of the primary PK parameters could have been calculated, and who had no important protocol deviations thought to impact on the analysis of the PK data. Number Analyzed in each row signifies only the participants with available data that were analyzed for BGF MDI.
Assessment of tmax of BGF when administered as 3 different propellant formulations.
Outcome measures
| Measure |
Treatment A
n=24 Participants
Participants received 2 inhalations of BGF MDI with Propellant 1 - test formulation (Treatment A)
|
Treatment B
n=22 Participants
Participants received 2 inhalations of BGF MDI with Propellant 2 - test formulation (Treatment B)
|
Treatment C
n=23 Participants
Participants received 2 inhalations of BGF MDI with HFA Propellant - reference formulation (Treatment C)
|
|---|---|---|---|
|
Time to Reach Maximum Observed Concentration (Tmax) of BGF MDI
Budesonide
|
0.50 hours
Interval 0.08 to 2.0
|
0.75 hours
Interval 0.08 to 2.0
|
0.52 hours
Interval 0.08 to 1.02
|
|
Time to Reach Maximum Observed Concentration (Tmax) of BGF MDI
Glycopyrronium
|
0.08 hours
Interval 0.03 to 0.75
|
0.08 hours
Interval 0.03 to 2.0
|
0.08 hours
Interval 0.03 to 2.0
|
|
Time to Reach Maximum Observed Concentration (Tmax) of BGF MDI
Formoterol
|
0.17 hours
Interval 0.08 to 2.0
|
0.50 hours
Interval 0.08 to 2.0
|
0.17 hours
Interval 0.07 to 2.0
|
SECONDARY outcome
Timeframe: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose and 1, 2, 4, 8, 12 and 24 hours post-dosePopulation: The PK Analysis Set consisted of all participants in the Safety Analysis Set for whom at least 1 of the primary PK parameters could have been calculated, and who had no important protocol deviations thought to impact on the analysis of the PK data. Number Analyzed in each row signifies only the participants with available data that were analyzed for BGF MDI.
Assessment of t½λz of BGF when administered as 3 different propellant formulations.
Outcome measures
| Measure |
Treatment A
n=17 Participants
Participants received 2 inhalations of BGF MDI with Propellant 1 - test formulation (Treatment A)
|
Treatment B
n=15 Participants
Participants received 2 inhalations of BGF MDI with Propellant 2 - test formulation (Treatment B)
|
Treatment C
n=15 Participants
Participants received 2 inhalations of BGF MDI with HFA Propellant - reference formulation (Treatment C)
|
|---|---|---|---|
|
Terminal Elimination Half-life (t½λz) of BGF MDI
Budesonide
|
4.420 hours
Standard Deviation 0.4003
|
4.438 hours
Standard Deviation 0.7886
|
4.574 hours
Standard Deviation 0.4267
|
|
Terminal Elimination Half-life (t½λz) of BGF MDI
Formoterol
|
NA hours
Standard Deviation NA
Three values were required as a minimum for PK parameters to be summarized as per protocol.
|
—
|
NA hours
Standard Deviation NA
Three values were required as a minimum for PK parameters to be summarized as per protocol.
|
SECONDARY outcome
Timeframe: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose and 1, 2, 4, 8, 12 and 24 hours post-dosePopulation: The PK Analysis Set consisted of all participants in the Safety Analysis Set for whom at least 1 of the primary PK parameters could have been calculated, and who had no important protocol deviations thought to impact on the analysis of the PK data. Number Analyzed in each row signifies only the participants with available data that were analyzed for BGF MDI.
Assessment of CL/F of BGF when administered as 3 different propellant formulations.
Outcome measures
| Measure |
Treatment A
n=24 Participants
Participants received 2 inhalations of BGF MDI with Propellant 1 - test formulation (Treatment A)
|
Treatment B
n=22 Participants
Participants received 2 inhalations of BGF MDI with Propellant 2 - test formulation (Treatment B)
|
Treatment C
n=21 Participants
Participants received 2 inhalations of BGF MDI with HFA Propellant - reference formulation (Treatment C)
|
|---|---|---|---|
|
Apparent Total Body Clearance of Drug After Extravascular Administration (CL/F) of BGF MDI
Budesonide
|
137.9 Litre/hour
Standard Deviation 43.28
|
148.6 Litre/hour
Standard Deviation 50.91
|
155.3 Litre/hour
Standard Deviation 105.4
|
|
Apparent Total Body Clearance of Drug After Extravascular Administration (CL/F) of BGF MDI
Glycopyrronium
|
502.6 Litre/hour
Standard Deviation 201.8
|
544.5 Litre/hour
Standard Deviation 158.1
|
NA Litre/hour
Standard Deviation NA
Three values were required as a minimum for PK parameters to be summarized as per protocol.
|
|
Apparent Total Body Clearance of Drug After Extravascular Administration (CL/F) of BGF MDI
Formoterol
|
108.8 Litre/hour
Standard Deviation 43.64
|
87.14 Litre/hour
Standard Deviation 32.16
|
108.3 Litre/hour
Standard Deviation 38.41
|
SECONDARY outcome
Timeframe: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose and 1, 2, 4, 8, 12 and 24 hours post-dosePopulation: The PK Analysis Set consisted of all participants in the Safety Analysis Set for whom at least 1 of the primary PK parameters could have been calculated, and who had no important protocol deviations thought to impact on the analysis of the PK data. Number Analyzed in each row signifies only the participants with available data that were analyzed for BGF MDI.
Assessment of Vz/F of BGF when administered as 3 different propellant formulations.
Outcome measures
| Measure |
Treatment A
n=24 Participants
Participants received 2 inhalations of BGF MDI with Propellant 1 - test formulation (Treatment A)
|
Treatment B
n=22 Participants
Participants received 2 inhalations of BGF MDI with Propellant 2 - test formulation (Treatment B)
|
Treatment C
n=21 Participants
Participants received 2 inhalations of BGF MDI with HFA Propellant - reference formulation (Treatment C)
|
|---|---|---|---|
|
Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) of BGF MDI
Budesonide
|
941.9 Litre
Standard Deviation 328.6
|
1023 Litre
Standard Deviation 330.4
|
1142 Litre
Standard Deviation 1005
|
|
Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) of BGF MDI
Glycopyrronium
|
1992 Litre
Standard Deviation 200.5
|
2079 Litre
Standard Deviation 638.9
|
NA Litre
Standard Deviation NA
Three values were required as a minimum for PK parameters to be summarized as per protocol.
|
|
Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) of BGF MDI
Formoterol
|
1171 Litre
Standard Deviation 281.2
|
1007 Litre
Standard Deviation 211.3
|
1167 Litre
Standard Deviation 180.9
|
SECONDARY outcome
Timeframe: Screening, Day -1 until Follow-up visit, up to 53 daysPopulation: The Safety Analysis Set included all participants who received at least 1 inhalation of any BGF MDI formulated treatment. This included all original and replacement participants where the 1 inhalation criterion was met.
Assessment of the safety and tolerability of a combination of BGF when administered as single doses in 3 different propellant formulations in healthy participants.
Outcome measures
| Measure |
Treatment A
n=47 Participants
Participants received 2 inhalations of BGF MDI with Propellant 1 - test formulation (Treatment A)
|
Treatment B
n=47 Participants
Participants received 2 inhalations of BGF MDI with Propellant 2 - test formulation (Treatment B)
|
Treatment C
n=47 Participants
Participants received 2 inhalations of BGF MDI with HFA Propellant - reference formulation (Treatment C)
|
|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAE) and Non-serious Adverse Events
Any AE
|
9 Participants
|
10 Participants
|
10 Participants
|
|
Number of Participants With Serious Adverse Events (SAE) and Non-serious Adverse Events
Any AE with outcome = death
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Serious Adverse Events (SAE) and Non-serious Adverse Events
Any serious AE (including events with outcome = death)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Serious Adverse Events (SAE) and Non-serious Adverse Events
Any AE leading to discontinuation of IMP
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Serious Adverse Events (SAE) and Non-serious Adverse Events
Any AE leading to withdrawal from study
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Treatment A
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Treatment B
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Treatment C
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A
n=47 participants at risk
Participants received 2 inhalations of BGF MDI with Propellant 1 - test formulation (Treatment A)
|
Treatment B
n=47 participants at risk
Participants received 2 inhalations of BGF MDI with Propellant 2 - test formulation (Treatment B)
|
Treatment C
n=47 participants at risk
Participants received 2 inhalations of BGF MDI with HFA Propellant - reference formulation (Treatment C)
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
4.3%
2/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
4.3%
2/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
4.3%
2/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
|
Nervous system disorders
Dizziness
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
|
Nervous system disorders
Somnolence
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
|
Nervous system disorders
Syncope
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
4.3%
2/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
|
General disorders
Medical device site dermatitis
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
4.3%
2/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
|
General disorders
Chest discomfort
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
|
General disorders
Chills
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
|
Gastrointestinal disorders
Abdominal distension
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
|
Gastrointestinal disorders
Constipation
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
|
Psychiatric disorders
Anxiety
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
|
Eye disorders
Hypermetropia
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
|
Reproductive system and breast disorders
Testicular pain
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.1%
1/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
0.00%
0/47 • Screening, Day -1 until Follow-up visit, up to 53 days
|
Additional Information
Global Clinical Head
AstraZeneca Clinical Study Information Center
Phone: 1-877-240-9479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee No unpublished information may be disclosed without prior written approval from AstraZeneca AB.
- Publication restrictions are in place
Restriction type: OTHER