Trial Outcomes & Findings for Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI With Next-Generation Propellant Compared With BGF MDI With HFA Propellant (NCT NCT05477108)
NCT ID: NCT05477108
Last Updated: 2025-08-28
Results Overview
Bioequivalence (Cmax) of the lung exposure of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO compared with BGF MDI HFA was assessed.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
108 participants
Primary outcome timeframe
Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hours (h), 2 h, 4 h, 8 h, 12h and 24 hours post-dose on Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Results posted on
2025-08-28
Participant Flow
This study was conducted between 29 July 2022 to 11 April 2023 at a single study center - Parexel Early Phase Clinical Unit (Baltimore).
The Screening period was up to 28 days. Informed Consent Form (ICF) was signed prior to screening procedures. All the study assessments were performed as per the schedule of assessment.
Participant milestones
| Measure |
Treatment Sequence ABB
Participant received 3 single dose treatment of Budesonide, Glycopyrronium, Formoterol (BGF) Metered Dose Inhaler (MDI) in 3 occasions.
Participant received BGF MDI Hydrofluoroolefin (HFO) (Treatment A); then BGF MDI Hydrofluoroalkane (HFA)(Treatment B); and then BGF MDI HFA (Treatment B) with oral activated charcoal prior and post dosing (A or B) on Day 1 with a washout period of 3 to 7 days between each dose.
|
Treatment Sequence BAB
Participant received 3 single dose treatment of BGF MDI in 3 occasions. Participant received BGF MDI HFA (Treatment B); then BGF MDI HFO (Treatment A); and then BGF MDI HFA (Treatment B) with oral activated charcoal prior and post dosing (A or B) on Day 1 with a washout period of 3 to 7 days between each dose.
|
Treatment Sequence BBA
Participant received 3 single dose treatment of BGF MDI in 3 occasions. Participant received BGF MDI HFA (Treatment B); then BGF MDI HFA (Treatment B); and then BGF MDI HFO (Treatment A) with oral activated charcoal prior and post dosing (A or B) on Day 1 with a washout period of 3 to 7 days between each dose.
|
|---|---|---|---|
|
Overall Study
STARTED
|
36
|
36
|
36
|
|
Overall Study
COMPLETED
|
35
|
35
|
33
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
3
|
Reasons for withdrawal
| Measure |
Treatment Sequence ABB
Participant received 3 single dose treatment of Budesonide, Glycopyrronium, Formoterol (BGF) Metered Dose Inhaler (MDI) in 3 occasions.
Participant received BGF MDI Hydrofluoroolefin (HFO) (Treatment A); then BGF MDI Hydrofluoroalkane (HFA)(Treatment B); and then BGF MDI HFA (Treatment B) with oral activated charcoal prior and post dosing (A or B) on Day 1 with a washout period of 3 to 7 days between each dose.
|
Treatment Sequence BAB
Participant received 3 single dose treatment of BGF MDI in 3 occasions. Participant received BGF MDI HFA (Treatment B); then BGF MDI HFO (Treatment A); and then BGF MDI HFA (Treatment B) with oral activated charcoal prior and post dosing (A or B) on Day 1 with a washout period of 3 to 7 days between each dose.
|
Treatment Sequence BBA
Participant received 3 single dose treatment of BGF MDI in 3 occasions. Participant received BGF MDI HFA (Treatment B); then BGF MDI HFA (Treatment B); and then BGF MDI HFO (Treatment A) with oral activated charcoal prior and post dosing (A or B) on Day 1 with a washout period of 3 to 7 days between each dose.
|
|---|---|---|---|
|
Overall Study
Participants randomized, not treated
|
1
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
|
Overall Study
withdrawn from study
|
0
|
0
|
1
|
Baseline Characteristics
Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI With Next-Generation Propellant Compared With BGF MDI With HFA Propellant
Baseline characteristics by cohort
| Measure |
Treatment Sequence ABB
n=36 Participants
Participant received 3 single dose treatment of Budesonide, Glycopyrronium, Formoterol (BGF) Metered Dose Inhaler (MDI) in 3 occasions.
Participant received BGF MDI Hydrofluoroolefin (HFO) (Treatment A); then BGF MDI Hydrofluoroalkane (HFA)(Treatment B); and then BGF MDI HFA (Treatment B) with oral activated charcoal prior and post dosing (A or B) on Day 1 with a washout period of 3 to 7 days between each dose.
|
Treatment Sequence BAB
n=36 Participants
Participant received 3 single dose treatment of BGF MDI in 3 occasions. Participant received BGF MDI HFA (Treatment B); then BGF MDI HFO (Treatment A); and then BGF MDI HFA (Treatment B) with oral activated charcoal prior and post dosing (A or B) on Day 1 with a washout period of 3 to 7 days between each dose.
|
Treatment Sequence BBA
n=36 Participants
Participant received 3 single dose treatment of BGF MDI in 3 occasions. Participant received BGF MDI HFA (Treatment B); then BGF MDI HFA (Treatment B); and then BGF MDI HFO (Treatment A) with oral activated charcoal prior and post dosing (A or B) on Day 1 with a washout period of 3 to 7 days between each dose.
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.9 Years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
37.8 Years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
38.6 Years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
38.1 Years
STANDARD_DEVIATION 11.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hours (h), 2 h, 4 h, 8 h, 12h and 24 hours post-dose on Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)Population: The PK analysis set consisted of all randomized participants who had at least 1 primary PK parameter that could be calculated, and who had no important protocol deviations thought to impact on the analysis of the PK data. Here, number of participants analyzed refers to number analyzed for each specific outcome measure.
Bioequivalence (Cmax) of the lung exposure of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO compared with BGF MDI HFA was assessed.
Outcome measures
| Measure |
Treatment A
n=101 Participants
Subjects received BGF MDI HFO; 4 inhalations as a single dose with oral activated charcoal, test formulation.
|
Treatment B (Replicate 1)
n=97 Participants
Subjects received BGF MDI HFA; 4 inhalations as a single dose with oral activated.
|
Treatment B (Replicate 2)
n=99 Participants
Subjects received BGF MDI HFA; 4 inhalations as a single dose with oral activated.
|
|---|---|---|---|
|
Maximum Observed Plasma (Peak) Drug Concentration (Cmax )
Budesonide
|
1078 picograms per milliliter (pg/mL)
Geometric Coefficient of Variation 61.09
|
1111 picograms per milliliter (pg/mL)
Geometric Coefficient of Variation 63.42
|
1045 picograms per milliliter (pg/mL)
Geometric Coefficient of Variation 73.36
|
|
Maximum Observed Plasma (Peak) Drug Concentration (Cmax )
Glycopyrronium
|
14.31 picograms per milliliter (pg/mL)
Geometric Coefficient of Variation 98.78
|
15.22 picograms per milliliter (pg/mL)
Geometric Coefficient of Variation 96.13
|
15.17 picograms per milliliter (pg/mL)
Geometric Coefficient of Variation 92.85
|
|
Maximum Observed Plasma (Peak) Drug Concentration (Cmax )
Formoterol
|
18.82 picograms per milliliter (pg/mL)
Geometric Coefficient of Variation 75.45
|
19.31 picograms per milliliter (pg/mL)
Geometric Coefficient of Variation 74.53
|
19.35 picograms per milliliter (pg/mL)
Geometric Coefficient of Variation 80.39
|
PRIMARY outcome
Timeframe: Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h, 12 h and 24 hours post-dose on Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)Population: The PK analysis set consisted of all randomized participants who had at least 1 primary PK parameter that could be calculated, and who had no important protocol deviations thought to impact on the analysis of the PK data. Here, number of participants analyzed refers to number analyzed for each specific outcome measure.
Bioequivalence (AUCinf) of the lung exposure of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO compared with BGF MDI HFA was assessed.
Outcome measures
| Measure |
Treatment A
n=101 Participants
Subjects received BGF MDI HFO; 4 inhalations as a single dose with oral activated charcoal, test formulation.
|
Treatment B (Replicate 1)
n=96 Participants
Subjects received BGF MDI HFA; 4 inhalations as a single dose with oral activated.
|
Treatment B (Replicate 2)
n=99 Participants
Subjects received BGF MDI HFA; 4 inhalations as a single dose with oral activated.
|
|---|---|---|---|
|
Area Under Plasma Concentration Time Curve From Zero to Infinity (AUCinf)
Budesonide
|
2533 hour (h)*pg/mL
Geometric Coefficient of Variation 61.57
|
2479 hour (h)*pg/mL
Geometric Coefficient of Variation 61.34
|
2507 hour (h)*pg/mL
Geometric Coefficient of Variation 76.08
|
|
Area Under Plasma Concentration Time Curve From Zero to Infinity (AUCinf)
Glycopyrronium
|
45.66 hour (h)*pg/mL
Geometric Coefficient of Variation 245.3
|
33.60 hour (h)*pg/mL
Geometric Coefficient of Variation 223.9
|
64.50 hour (h)*pg/mL
Geometric Coefficient of Variation 271.8
|
|
Area Under Plasma Concentration Time Curve From Zero to Infinity (AUCinf)
Formoterol
|
54.12 hour (h)*pg/mL
Geometric Coefficient of Variation 85.90
|
53.36 hour (h)*pg/mL
Geometric Coefficient of Variation 85.09
|
53.70 hour (h)*pg/mL
Geometric Coefficient of Variation 111.9
|
PRIMARY outcome
Timeframe: Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h, 12 h and 24 hours post-dose on Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)Population: The PK analysis set consisted of all randomized participants who had at least 1 primary PK parameter that could be calculated, and who had no important protocol deviations thought to impact on the analysis of the PK data. Here, number of participants analyzed refers to number analyzed for each specific outcome measure.
Bioequivalence (AUClast) of the lung exposure of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO compared with BGF MDI HFA was assessed.
Outcome measures
| Measure |
Treatment A
n=101 Participants
Subjects received BGF MDI HFO; 4 inhalations as a single dose with oral activated charcoal, test formulation.
|
Treatment B (Replicate 1)
n=97 Participants
Subjects received BGF MDI HFA; 4 inhalations as a single dose with oral activated.
|
Treatment B (Replicate 2)
n=99 Participants
Subjects received BGF MDI HFA; 4 inhalations as a single dose with oral activated.
|
|---|---|---|---|
|
Area Under the Plasma Concentration Curve From Zero to the Last Quantifiable Concentration (AUClast)
Budesonide
|
2460 hours (h)*pg/mL
Geometric Coefficient of Variation 63.25
|
2398 hours (h)*pg/mL
Geometric Coefficient of Variation 62.89
|
2421 hours (h)*pg/mL
Geometric Coefficient of Variation 78.43
|
|
Area Under the Plasma Concentration Curve From Zero to the Last Quantifiable Concentration (AUClast)
Glycopyrronium
|
25.11 hours (h)*pg/mL
Geometric Coefficient of Variation 182.1
|
20.34 hours (h)*pg/mL
Geometric Coefficient of Variation 190.9
|
34.58 hours (h)*pg/mL
Geometric Coefficient of Variation 180.3
|
|
Area Under the Plasma Concentration Curve From Zero to the Last Quantifiable Concentration (AUClast)
Formoterol
|
36.47 hours (h)*pg/mL
Geometric Coefficient of Variation 112.8
|
35.68 hours (h)*pg/mL
Geometric Coefficient of Variation 117.6
|
35.83 hours (h)*pg/mL
Geometric Coefficient of Variation 160.9
|
SECONDARY outcome
Timeframe: Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h, 12 h and 24 hours post-dose on Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)Population: The PK analysis set consisted of all randomized participants who had at least 1 primary PK parameter that could be calculated, and who had no important protocol deviations thought to impact on the analysis of the PK data. Here, number of participants analyzed refers to number analyzed for each specific outcome measure.
The tmax as PK profiles of BGF administered as BGF MDI HFO and BGF MDI HFA with oral activated charcoal was assessed.
Outcome measures
| Measure |
Treatment A
n=101 Participants
Subjects received BGF MDI HFO; 4 inhalations as a single dose with oral activated charcoal, test formulation.
|
Treatment B (Replicate 1)
n=97 Participants
Subjects received BGF MDI HFA; 4 inhalations as a single dose with oral activated.
|
Treatment B (Replicate 2)
n=99 Participants
Subjects received BGF MDI HFA; 4 inhalations as a single dose with oral activated.
|
|---|---|---|---|
|
Time to Reach Peak or Maximum Observed Concentration or Response Following Drug Administration (Tmax)
Budesonide
|
0.33 hours
Interval 0.07 to 1.13
|
0.32 hours
Interval 0.07 to 4.0
|
0.33 hours
Interval 0.05 to 1.02
|
|
Time to Reach Peak or Maximum Observed Concentration or Response Following Drug Administration (Tmax)
Glycopyrronium
|
0.05 hours
Interval 0.03 to 0.33
|
0.07 hours
Interval 0.03 to 0.22
|
0.05 hours
Interval 0.03 to 0.2
|
|
Time to Reach Peak or Maximum Observed Concentration or Response Following Drug Administration (Tmax)
Formoterol
|
0.08 hours
Interval 0.03 to 0.22
|
0.08 hours
Interval 0.03 to 0.22
|
0.08 hours
Interval 0.03 to 0.2
|
SECONDARY outcome
Timeframe: Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h, 12 h and 24 hours post-dose on Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)Population: The PK analysis set consisted of all randomized participants who had at least 1 primary PK parameter that could be calculated, and who had no important protocol deviations thought to impact on the analysis of the PK data. Here, number of participants analyzed refers to number analyzed for each specific outcome measure.
The t½λz as PK profiles of BGF administered as BGF MDI HFO and BGF MDI HFA with oral activated charcoal was assessed.
Outcome measures
| Measure |
Treatment A
n=101 Participants
Subjects received BGF MDI HFO; 4 inhalations as a single dose with oral activated charcoal, test formulation.
|
Treatment B (Replicate 1)
n=96 Participants
Subjects received BGF MDI HFA; 4 inhalations as a single dose with oral activated.
|
Treatment B (Replicate 2)
n=99 Participants
Subjects received BGF MDI HFA; 4 inhalations as a single dose with oral activated.
|
|---|---|---|---|
|
Half Life Associated With Terminal Slope (λz) of a Semi Logarithmic Concentration Time Curve (t½λz)
Budesonide
|
3.661 hours
Geometric Coefficient of Variation 32.13
|
3.304 hours
Geometric Coefficient of Variation 30.86
|
3.656 hours
Geometric Coefficient of Variation 33.60
|
|
Half Life Associated With Terminal Slope (λz) of a Semi Logarithmic Concentration Time Curve (t½λz)
Glycopyrronium
|
9.063 hours
Geometric Coefficient of Variation 300.9
|
6.025 hours
Geometric Coefficient of Variation 308.2
|
13.30 hours
Geometric Coefficient of Variation 302.7
|
|
Half Life Associated With Terminal Slope (λz) of a Semi Logarithmic Concentration Time Curve (t½λz)
Formoterol
|
6.997 hours
Geometric Coefficient of Variation 53.32
|
6.444 hours
Geometric Coefficient of Variation 64.95
|
7.082 hours
Geometric Coefficient of Variation 77.98
|
SECONDARY outcome
Timeframe: Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h, 12 h and 24 hours post-dose on Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)Population: The PK analysis set consisted of all randomized participants who had at least 1 primary PK parameter that could be calculated, and who had no important protocol deviations thought to impact on the analysis of the PK data. Here, number of participants analyzed refers to number analyzed for each specific outcome measure.
The λz PK profiles of BGF administered as BGF MDI HFO and BGF MDI HFA with oral activated charcoal was assessed.
Outcome measures
| Measure |
Treatment A
n=101 Participants
Subjects received BGF MDI HFO; 4 inhalations as a single dose with oral activated charcoal, test formulation.
|
Treatment B (Replicate 1)
n=96 Participants
Subjects received BGF MDI HFA; 4 inhalations as a single dose with oral activated.
|
Treatment B (Replicate 2)
n=99 Participants
Subjects received BGF MDI HFA; 4 inhalations as a single dose with oral activated.
|
|---|---|---|---|
|
Terminal Rate Constant (λz)
Budesonide
|
0.1893 1/hour
Geometric Coefficient of Variation 32.13
|
0.2098 1/hour
Geometric Coefficient of Variation 30.86
|
0.1896 1/hour
Geometric Coefficient of Variation 33.60
|
|
Terminal Rate Constant (λz)
Glycopyrronium
|
0.07648 1/hour
Geometric Coefficient of Variation 300.9
|
0.1151 1/hour
Geometric Coefficient of Variation 308.2
|
0.05213 1/hour
Geometric Coefficient of Variation 302.7
|
|
Terminal Rate Constant (λz)
Formoterol
|
0.09907 1/hour
Geometric Coefficient of Variation 53.32
|
0.1076 1/hour
Geometric Coefficient of Variation 64.95
|
0.09787 1/hour
Geometric Coefficient of Variation 77.98
|
SECONDARY outcome
Timeframe: Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h, 12 h and 24 hours post-dose on Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)Population: The PK analysis set consisted of all randomized participants who had at least 1 primary PK parameter that could be calculated, and who had no important protocol deviations thought to impact on the analysis of the PK data. Here, number of participants analyzed refers to number analyzed for each specific outcome measure.
The MRTinf PK profiles of BGF administered as BGF MDI HFO and BGF MDI HFA with oral activated charcoal was assessed.
Outcome measures
| Measure |
Treatment A
n=101 Participants
Subjects received BGF MDI HFO; 4 inhalations as a single dose with oral activated charcoal, test formulation.
|
Treatment B (Replicate 1)
n=96 Participants
Subjects received BGF MDI HFA; 4 inhalations as a single dose with oral activated.
|
Treatment B (Replicate 2)
n=99 Participants
Subjects received BGF MDI HFA; 4 inhalations as a single dose with oral activated.
|
|---|---|---|---|
|
Mean Residence Time of the Unchanged Drug in the Systemic Circulation From Zero to Infinity (MRTinf)
Budesonide
|
3.893 hours
Geometric Coefficient of Variation 21.04
|
3.771 hours
Geometric Coefficient of Variation 23.43
|
3.978 hours
Geometric Coefficient of Variation 22.85
|
|
Mean Residence Time of the Unchanged Drug in the Systemic Circulation From Zero to Infinity (MRTinf)
Glycopyrronium
|
12.04 hours
Geometric Coefficient of Variation 294.9
|
7.991 hours
Geometric Coefficient of Variation 295.0
|
18.30 hours
Geometric Coefficient of Variation 293.0
|
|
Mean Residence Time of the Unchanged Drug in the Systemic Circulation From Zero to Infinity (MRTinf)
Formoterol
|
9.139 hours
Geometric Coefficient of Variation 51.58
|
8.497 hours
Geometric Coefficient of Variation 62.87
|
9.254 hours
Geometric Coefficient of Variation 75.92
|
SECONDARY outcome
Timeframe: Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h, 12 h and 24 hours post-dose on Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)Population: The PK analysis set consisted of all randomized participants who had at least 1 primary PK parameter that could be calculated, and who had no important protocol deviations thought to impact on the analysis of the PK data. Here, number of participants analyzed refers to number analyzed for each specific outcome measure.
The CL/F PK profiles of BGF administered as BGF MDI HFO and BGF MDI HFA with oral activated charcoal was assessed.
Outcome measures
| Measure |
Treatment A
n=101 Participants
Subjects received BGF MDI HFO; 4 inhalations as a single dose with oral activated charcoal, test formulation.
|
Treatment B (Replicate 1)
n=96 Participants
Subjects received BGF MDI HFA; 4 inhalations as a single dose with oral activated.
|
Treatment B (Replicate 2)
n=99 Participants
Subjects received BGF MDI HFA; 4 inhalations as a single dose with oral activated.
|
|---|---|---|---|
|
Apparent Total Body Clearance of Drug From Plasma After Extravascular Administration (CL/F)
Budesonide
|
250.7 Litre/hour (L/h)
Geometric Coefficient of Variation 61.57
|
258.2 Litre/hour (L/h)
Geometric Coefficient of Variation 61.34
|
255.2 Litre/hour (L/h)
Geometric Coefficient of Variation 76.08
|
|
Apparent Total Body Clearance of Drug From Plasma After Extravascular Administration (CL/F)
Glycopyrronium
|
630.7 Litre/hour (L/h)
Geometric Coefficient of Variation 245.3
|
857.2 Litre/hour (L/h)
Geometric Coefficient of Variation 223.9
|
446.5 Litre/hour (L/h)
Geometric Coefficient of Variation 271.8
|
|
Apparent Total Body Clearance of Drug From Plasma After Extravascular Administration (CL/F)
Formoterol
|
354.8 Litre/hour (L/h)
Geometric Coefficient of Variation 85.90
|
359.8 Litre/hour (L/h)
Geometric Coefficient of Variation 85.09
|
357.5 Litre/hour (L/h)
Geometric Coefficient of Variation 111.9
|
SECONDARY outcome
Timeframe: Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h, 12 h and 24 hours post-dose on Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)Population: The PK analysis set consisted of all randomized participants who had at least 1 primary PK parameter that could be calculated, and who had no important protocol deviations thought to impact on the analysis of the PK data. Here, number of participants analyzed refers to number analyzed for each specific outcome measure.
The Vz/F PK profiles of BGF administered as BGF MDI HFO and BGF MDI HFA with oral activated charcoal was assessed.
Outcome measures
| Measure |
Treatment A
n=101 Participants
Subjects received BGF MDI HFO; 4 inhalations as a single dose with oral activated charcoal, test formulation.
|
Treatment B (Replicate 1)
n=96 Participants
Subjects received BGF MDI HFA; 4 inhalations as a single dose with oral activated.
|
Treatment B (Replicate 2)
n=99 Participants
Subjects received BGF MDI HFA; 4 inhalations as a single dose with oral activated.
|
|---|---|---|---|
|
Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Based on Terminal Phase) (Vz/F)
Budesonide
|
1324 Litre (L)
Geometric Coefficient of Variation 57.12
|
1231 Litre (L)
Geometric Coefficient of Variation 59.34
|
1346 Litre (L)
Geometric Coefficient of Variation 69.25
|
|
Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Based on Terminal Phase) (Vz/F)
Glycopyrronium
|
8247 Litre (L)
Geometric Coefficient of Variation 41.09
|
7451 Litre (L)
Geometric Coefficient of Variation 53.30
|
8566 Litre (L)
Geometric Coefficient of Variation 44.65
|
|
Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Based on Terminal Phase) (Vz/F)
Formoterol
|
3581 Litre (L)
Geometric Coefficient of Variation 49.08
|
3345 Litre (L)
Geometric Coefficient of Variation 49.90
|
3653 Litre (L)
Geometric Coefficient of Variation 46.55
|
SECONDARY outcome
Timeframe: From screening (Day -28 to Day -1) up to 55 daysPopulation: The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI.
The safety and tolerability of single doses of BGF MDI HFO and BGF MDI HFA with oral activated charcoal in healthy subjects was assessed.
Outcome measures
| Measure |
Treatment A
n=103 Participants
Subjects received BGF MDI HFO; 4 inhalations as a single dose with oral activated charcoal, test formulation.
|
Treatment B (Replicate 1)
n=105 Participants
Subjects received BGF MDI HFA; 4 inhalations as a single dose with oral activated.
|
Treatment B (Replicate 2)
n=104 Participants
Subjects received BGF MDI HFA; 4 inhalations as a single dose with oral activated.
|
|---|---|---|---|
|
Number of Participants With Adverse Events
Any AE
|
12 Participants
|
19 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events
Any SAE with outcome of death
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Any AE leading to discontinuation of study intervention
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
Any possibly related AE
|
4 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events
Any possibly related SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Treatment A
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Treatment B (Replicate 1)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Treatment B (Replicate 2)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A
n=103 participants at risk
Subjects received BGF MDI HFO; 4 inhalations as a single dose with oral activated charcoal, test formulation.
|
Treatment B (Replicate 1)
n=105 participants at risk
Subjects received BGF MDI HFA per actuation; 4 inhalations as a single dose with oral activated.
|
Treatment B (Replicate 2)
n=104 participants at risk
Subjects received BGF MDI HFA; 4 inhalations as a single dose with oral activated.
|
|---|---|---|---|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/103 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.95%
1/105 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/104 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/103 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.95%
1/105 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/104 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
|
Nervous system disorders
Headache
|
1.9%
2/103 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
2.9%
3/105 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.96%
1/104 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/103 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.95%
1/105 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/104 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/103 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
2.9%
3/105 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/104 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/103 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.95%
1/105 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.96%
1/104 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.97%
1/103 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/105 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/104 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/103 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.95%
1/105 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/104 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/103 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.95%
1/105 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/104 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.97%
1/103 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
1.9%
2/105 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/104 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
2/103 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/105 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/104 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.97%
1/103 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/105 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/104 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
|
Gastrointestinal disorders
Constipation
|
0.97%
1/103 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.95%
1/105 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/104 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.97%
1/103 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/105 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/104 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
|
Gastrointestinal disorders
Faeces discoloured
|
1.9%
2/103 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
1.9%
2/105 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/104 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
|
Gastrointestinal disorders
Nausea
|
1.9%
2/103 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
1.9%
2/105 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/104 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
|
Gastrointestinal disorders
Vomiting
|
0.97%
1/103 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.95%
1/105 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/104 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.97%
1/103 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/105 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/104 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.97%
1/103 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/105 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/104 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/103 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.95%
1/105 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/104 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
|
General disorders
Catheter site bruise
|
0.00%
0/103 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.95%
1/105 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/104 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
|
General disorders
Catheter site swelling
|
0.00%
0/103 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/105 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.96%
1/104 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
|
General disorders
Vessel puncture site bruise
|
1.9%
2/103 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
1.9%
2/105 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/104 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/103 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/105 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.96%
1/104 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
|
General disorders
Vessel puncture site pain
|
0.97%
1/103 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.95%
1/105 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/104 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
|
General disorders
Vessel puncture site swelling
|
0.00%
0/103 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.95%
1/105 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/104 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/103 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.95%
1/105 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
0.00%
0/104 • From screening (Day -28 to Day -1) up to 55 days
The safety analysis set included all participants who received at least 1 inhalation of any BGF MDI. Adverse events that were collected from the start of screening throughout the Treatment period up to and including the final follow-up Phone call was presented.
|
Additional Information
Global Clinical Lead
AstraZeneca Clinical Study Information Center
Phone: +1-877-240-94 79
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee No unpublished information contained herein may be disclosed without prior written approval from AstraZeneca AB.
- Publication restrictions are in place
Restriction type: OTHER