Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered Dose Inhaler (BDA MDI/PT027) Used 4 Times Daily in Adults and Children 4 Years of Age or Older With Asthma (NCT NCT03847896)

Last Updated: 2023-04-13

Results Overview

Lung function will be measured by spirometry. Baseline FEV1 will be taken as the average of the 60- and 30-minute pre-dose spirometry measures on or before randomization. Starting with the first study drug dose at Week 0 and then at Week 12, spirometry assessments will be completed at 60 and 30 minutes before the morning dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes after dosing. FEV1 AUC0-6 hours will be calculated for changes from baseline (randomization visit) using the trapezoidal rule and will be normalized by dividing by the time (in hours) from dosing to the last measurement included (typically 6 hours).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1001 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2023-04-13

Participant Flow

The first subject enrolled on 20 March 2019 and the last subjected completed the study on 20 July 2021. Subjects were enrolled at 126 study centers worldwide (Argentina, Czechia, Germany, Serbia, Slovakia, Ukraine and the United States).

The randomized treatment phase started after a 2 to 4 week screening period during which participants self-administered single-blind Placebo MDI QID and Ventolin as needed to be used in response to asthma symptoms. In addition to the 1,001 subjects randomized, 875 subjects were screened but did not participate, of which 851 (97.3%) were ineligible, 3 were lost to follow up, 1 was excluded due to a protocol deviation, 18 withdrew by subject decision, and 2 withdrew by parent/guardian decision.

Participant milestones

Participant milestones
Measure	BDA MDI (PT027) 160/180 μg Budesonide/Albuterol sulfate BDA MDI (PT027) high dose Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose): Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 160/180 micrograms (μg), given as 2 inhalations of BDA MDI 80/90 μg, four times a day (QID)	BDA MDI (PT027) 80/180 μg Budesonide/Albuterol sulfate BDA MDI (PT027) low dose Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 80/180 μg (low dose): Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 80/180 micrograms (μg), given as 2 inhalations of BDA MDI 40/90 μg, four times a day (QID)	BD MDI (PT008) 160 µg Budesonide BD MDI (PT008) Budesonide metered dose inhaler / BD MDI 160 µg: Budesonide pressurized metered dose inhaler (BD MDI) 160 micrograms (μg), given as 2 inhalations of BD MDI 80 μg, four times a day (QID)	AS MDI (PT007) 180 µg Albuterol sulfate AS MDI (PT007) Albuterol sulfate metered dose inhaler / AS MDI 180 μg: Albuterol sulfate pressurized metered dose inhaler (AS MDI) 180 micrograms (μg), given as 2 inhalations of AS MDI 90 μg, four times a day (QID)	Placebo MDI Placebo MDI Placebo metered-dose inhaler / Placebo MDI: Placebo pressurized metered dose inhaler (Placebo MDI), given as 2 inhalations of Placebo MDI, four times a day (QID)
Overall Study STARTED	197	204	200	201	199
Overall Study COMPLETED	190	188	188	184	178
Overall Study NOT COMPLETED	7	16	12	17	21

Reasons for withdrawal

Reasons for withdrawal
Measure	BDA MDI (PT027) 160/180 μg Budesonide/Albuterol sulfate BDA MDI (PT027) high dose Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose): Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 160/180 micrograms (μg), given as 2 inhalations of BDA MDI 80/90 μg, four times a day (QID)	BDA MDI (PT027) 80/180 μg Budesonide/Albuterol sulfate BDA MDI (PT027) low dose Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 80/180 μg (low dose): Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 80/180 micrograms (μg), given as 2 inhalations of BDA MDI 40/90 μg, four times a day (QID)	BD MDI (PT008) 160 µg Budesonide BD MDI (PT008) Budesonide metered dose inhaler / BD MDI 160 µg: Budesonide pressurized metered dose inhaler (BD MDI) 160 micrograms (μg), given as 2 inhalations of BD MDI 80 μg, four times a day (QID)	AS MDI (PT007) 180 µg Albuterol sulfate AS MDI (PT007) Albuterol sulfate metered dose inhaler / AS MDI 180 μg: Albuterol sulfate pressurized metered dose inhaler (AS MDI) 180 micrograms (μg), given as 2 inhalations of AS MDI 90 μg, four times a day (QID)	Placebo MDI Placebo MDI Placebo metered-dose inhaler / Placebo MDI: Placebo pressurized metered dose inhaler (Placebo MDI), given as 2 inhalations of Placebo MDI, four times a day (QID)
Overall Study Randomized in error and did not receive randomized study treatment	0	0	1	0	0
Overall Study Withdrawal by Subject	2	10	5	9	8
Overall Study Withdrawal by parent/guardian	0	0	1	0	0
Overall Study Adverse Event	2	1	3	2	4
Overall Study A severe exacerbation event	0	0	0	0	3
Overall Study Protocol Violation	0	2	1	0	2
Overall Study Lost to Follow-up	0	0	0	1	0
Overall Study Condition under investigation worsened	0	0	0	1	1
Overall Study Lack of Efficacy	0	0	0	2	2
Overall Study Other reasons	3	3	1	2	1

Baseline Characteristics

A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered Dose Inhaler (BDA MDI/PT027) Used 4 Times Daily in Adults and Children 4 Years of Age or Older With Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BDA MDI (PT027) 160/180 μg n=197 Participants Budesonide/Albuterol sulfate BDA MDI (PT027) high dose Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose): Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 160/180 micrograms (μg), given as 2 inhalations of BDA MDI 80/90 μg, four times a day (QID)	BDA MDI (PT027) 80/180 μg n=204 Participants Budesonide/Albuterol sulfate BDA MDI (PT027) low dose Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 80/180 μg (low dose): Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 80/180 micrograms (μg), given as 2 inhalations of BDA MDI 40/90 μg, four times a day (QID)	BD MDI (PT008) 160 µg n=199 Participants Budesonide BD MDI (PT008) Budesonide metered dose inhaler / BD MDI 160 µg: Budesonide pressurized metered dose inhaler (BD MDI) 160 micrograms (μg), given as 2 inhalations of BD MDI 80 μg, four times a day (QID)	AS MDI (PT007) 180 µg n=201 Participants Albuterol sulfate AS MDI (PT007) Albuterol sulfate metered dose inhaler / AS MDI 180 μg: Albuterol sulfate pressurized metered dose inhaler (AS MDI) 180 micrograms (μg), given as 2 inhalations of AS MDI 90 μg, four times a day (QID)	Placebo MDI n=199 Participants Placebo MDI Placebo metered-dose inhaler / Placebo MDI: Placebo pressurized metered dose inhaler (Placebo MDI), given as 2 inhalations of Placebo MDI, four times a day (QID)	Total n=1000 Participants Total of all reporting groups
Age, Continuous	50.0 years STANDARD_DEVIATION 15.80 • n=5 Participants	48.7 years STANDARD_DEVIATION 16.79 • n=7 Participants	48.3 years STANDARD_DEVIATION 15.80 • n=5 Participants	47.0 years STANDARD_DEVIATION 16.79 • n=4 Participants	48.6 years STANDARD_DEVIATION 15.82 • n=21 Participants	48.5 years STANDARD_DEVIATION 16.21 • n=8 Participants
Age, Customized Children (>=4 to <12 years)	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	10 Participants n=8 Participants
Age, Customized Adolescents (>=12 to <18 years)	4 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	25 Participants n=8 Participants
Age, Customized Adults (>=18 to <65 years)	154 Participants n=5 Participants	155 Participants n=7 Participants	161 Participants n=5 Participants	159 Participants n=4 Participants	161 Participants n=21 Participants	790 Participants n=8 Participants
Age, Customized Elderly (>=65 years)	39 Participants n=5 Participants	39 Participants n=7 Participants	33 Participants n=5 Participants	33 Participants n=4 Participants	31 Participants n=21 Participants	175 Participants n=8 Participants
Sex: Female, Male Female	125 Participants n=5 Participants	128 Participants n=7 Participants	120 Participants n=5 Participants	121 Participants n=4 Participants	127 Participants n=21 Participants	621 Participants n=8 Participants
Sex: Female, Male Male	72 Participants n=5 Participants	76 Participants n=7 Participants	79 Participants n=5 Participants	80 Participants n=4 Participants	72 Participants n=21 Participants	379 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	61 Participants n=5 Participants	62 Participants n=7 Participants	50 Participants n=5 Participants	46 Participants n=4 Participants	63 Participants n=21 Participants	282 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	136 Participants n=5 Participants	142 Participants n=7 Participants	149 Participants n=5 Participants	155 Participants n=4 Participants	136 Participants n=21 Participants	718 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
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 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	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	15 Participants n=7 Participants	18 Participants n=5 Participants	30 Participants n=4 Participants	19 Participants n=21 Participants	96 Participants n=8 Participants
Race (NIH/OMB) White	179 Participants n=5 Participants	185 Participants n=7 Participants	180 Participants n=5 Participants	167 Participants n=4 Participants	174 Participants n=21 Participants	885 Participants n=8 Participants
Race (NIH/OMB) More than one race	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
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	14 Participants n=8 Participants
Region of Enrollment Argentina	9 participants n=5 Participants	11 participants n=7 Participants	14 participants n=5 Participants	14 participants n=4 Participants	6 participants n=21 Participants	54 participants n=8 Participants
Region of Enrollment United States	100 participants n=5 Participants	106 participants n=7 Participants	100 participants n=5 Participants	107 participants n=4 Participants	109 participants n=21 Participants	522 participants n=8 Participants
Region of Enrollment Czechia	12 participants n=5 Participants	12 participants n=7 Participants	12 participants n=5 Participants	17 participants n=4 Participants	18 participants n=21 Participants	71 participants n=8 Participants
Region of Enrollment Ukraine	44 participants n=5 Participants	44 participants n=7 Participants	43 participants n=5 Participants	32 participants n=4 Participants	40 participants n=21 Participants	203 participants n=8 Participants
Region of Enrollment Slovakia	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	1 participants n=8 Participants
Region of Enrollment Serbia	3 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants	2 participants n=4 Participants	2 participants n=21 Participants	11 participants n=8 Participants
Region of Enrollment Germany	28 participants n=5 Participants	30 participants n=7 Participants	27 participants n=5 Participants	29 participants n=4 Participants	24 participants n=21 Participants	138 participants n=8 Participants
Height	167.8 centimeters STANDARD_DEVIATION 8.61 • n=5 Participants	166.8 centimeters STANDARD_DEVIATION 9.71 • n=7 Participants	167.7 centimeters STANDARD_DEVIATION 9.92 • n=5 Participants	168.6 centimeters STANDARD_DEVIATION 9.86 • n=4 Participants	168.0 centimeters STANDARD_DEVIATION 10.85 • n=21 Participants	167.8 centimeters STANDARD_DEVIATION 9.81 • n=8 Participants
Weight	80.4 kilograms STANDARD_DEVIATION 16.43 • n=5 Participants	80.0 kilograms STANDARD_DEVIATION 16.06 • n=7 Participants	80.0 kilograms STANDARD_DEVIATION 14.52 • n=5 Participants	82.3 kilograms STANDARD_DEVIATION 15.09 • n=4 Participants	81.6 kilograms STANDARD_DEVIATION 17.79 • n=21 Participants	80.9 kilograms STANDARD_DEVIATION 16.02 • n=8 Participants
Body Mass Index	28.537 kg/m^2 STANDARD_DEVIATION 5.2488 • n=5 Participants	28.635 kg/m^2 STANDARD_DEVIATION 4.8491 • n=7 Participants	28.477 kg/m^2 STANDARD_DEVIATION 4.9140 • n=5 Participants	29.016 kg/m^2 STANDARD_DEVIATION 4.8513 • n=4 Participants	28.793 kg/m^2 STANDARD_DEVIATION 5.2534 • n=21 Participants	28.691 kg/m^2 STANDARD_DEVIATION 5.0211 • n=8 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Outcome measures

Outcome measures
Measure	BDA MDI (PT027) 160/180 μg n=197 Participants Budesonide/Albuterol sulfate BDA MDI (PT027) high dose Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose): Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 160/180 micrograms (μg), given as 2 inhalations of BDA MDI 80/90 μg, four times a day (QID)	BDA MDI (PT027) 80/180 μg n=200 Participants Budesonide/Albuterol sulfate BDA MDI (PT027) low dose Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 80/180 μg (low dose): Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 80/180 micrograms (μg), given as 2 inhalations of BDA MDI 40/90 μg, four times a day (QID)	BD MDI (PT008) 160 µg n=199 Participants Budesonide BD MDI (PT008) Budesonide metered dose inhaler / BD MDI 160 µg: Budesonide pressurized metered dose inhaler (BD MDI) 160 micrograms (μg), given as 2 inhalations of BD MDI 80 μg, four times a day (QID)	AS MDI (PT007) 180 µg n=195 Participants Albuterol sulfate AS MDI (PT007) Albuterol sulfate metered dose inhaler / AS MDI 180 μg: Albuterol sulfate pressurized metered dose inhaler (AS MDI) 180 micrograms (μg), given as 2 inhalations of AS MDI 90 μg, four times a day (QID)	Placebo MDI n=196 Participants Placebo MDI Placebo metered-dose inhaler / Placebo MDI: Placebo pressurized metered dose inhaler (Placebo MDI), given as 2 inhalations of Placebo MDI, four times a day (QID)
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Concentration Curve From 0 to 6 Hours (AUC0-6 Hours) Over 12 Weeks	258.6 milliliters Standard Error 18.87	242.2 milliliters Standard Error 18.80	178.0 milliliters Standard Error 18.79	157.2 milliliters Standard Error 19.08	96.7 milliliters Standard Error 19.02

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Trough FEV1 is calculated at each clinic visit as the average of the 30- and 60-minute pre-dose FEV1 measurements. Baseline FEV1 is defined as the average of the 30- and 60-minute pre-dose measures collected on the day of randomization.

Outcome measures

Outcome measures
Measure	BDA MDI (PT027) 160/180 μg n=197 Participants Budesonide/Albuterol sulfate BDA MDI (PT027) high dose Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose): Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 160/180 micrograms (μg), given as 2 inhalations of BDA MDI 80/90 μg, four times a day (QID)	BDA MDI (PT027) 80/180 μg n=198 Participants Budesonide/Albuterol sulfate BDA MDI (PT027) low dose Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 80/180 μg (low dose): Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 80/180 micrograms (μg), given as 2 inhalations of BDA MDI 40/90 μg, four times a day (QID)	BD MDI (PT008) 160 µg n=198 Participants Budesonide BD MDI (PT008) Budesonide metered dose inhaler / BD MDI 160 µg: Budesonide pressurized metered dose inhaler (BD MDI) 160 micrograms (μg), given as 2 inhalations of BD MDI 80 μg, four times a day (QID)	AS MDI (PT007) 180 µg n=192 Participants Albuterol sulfate AS MDI (PT007) Albuterol sulfate metered dose inhaler / AS MDI 180 μg: Albuterol sulfate pressurized metered dose inhaler (AS MDI) 180 micrograms (μg), given as 2 inhalations of AS MDI 90 μg, four times a day (QID)	Placebo MDI n=192 Participants Placebo MDI Placebo metered-dose inhaler / Placebo MDI: Placebo pressurized metered dose inhaler (Placebo MDI), given as 2 inhalations of Placebo MDI, four times a day (QID)
Change From Baseline in Trough FEV1	135.5 milliliters Standard Error 24.58	123.5 milliliters Standard Error 24.65	108.9 milliliters Standard Error 24.51	2.7 milliliters Standard Error 25.24	35.6 milliliters Standard Error 25.12

SECONDARY outcome

Timeframe: From first dose (first inhalation of randomized treatment) up to about 40 minutes post-dose (Day 1).

Population: Participants were only included in the analyses if a percent change from baseline of at least 15% is observed within the nominal 30 minutes post-dose.

The time to onset is defined as the time (minutes) from the first inhalation of randomized treatment (Day 1) to the first instance where a percentage change from baseline in FEV1 of at least 15% is observed. Participants were only to be included in the analysis if a percent change from baseline of at least 15% is observed within a nominal 30 minutes post dose assessment time point. Baseline FEV1 is defined as the average of the 30- and 60- minute pre-dose spirometry measures taken at randomization.

Outcome measures

Outcome measures
Measure	BDA MDI (PT027) 160/180 μg n=98 Participants Budesonide/Albuterol sulfate BDA MDI (PT027) high dose Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose): Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 160/180 micrograms (μg), given as 2 inhalations of BDA MDI 80/90 μg, four times a day (QID)	BDA MDI (PT027) 80/180 μg n=88 Participants Budesonide/Albuterol sulfate BDA MDI (PT027) low dose Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 80/180 μg (low dose): Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 80/180 micrograms (μg), given as 2 inhalations of BDA MDI 40/90 μg, four times a day (QID)	BD MDI (PT008) 160 µg n=27 Participants Budesonide BD MDI (PT008) Budesonide metered dose inhaler / BD MDI 160 µg: Budesonide pressurized metered dose inhaler (BD MDI) 160 micrograms (μg), given as 2 inhalations of BD MDI 80 μg, four times a day (QID)	AS MDI (PT007) 180 µg n=84 Participants Albuterol sulfate AS MDI (PT007) Albuterol sulfate metered dose inhaler / AS MDI 180 μg: Albuterol sulfate pressurized metered dose inhaler (AS MDI) 180 micrograms (μg), given as 2 inhalations of AS MDI 90 μg, four times a day (QID)	Placebo MDI n=26 Participants Placebo MDI Placebo metered-dose inhaler / Placebo MDI: Placebo pressurized metered dose inhaler (Placebo MDI), given as 2 inhalations of Placebo MDI, four times a day (QID)
Time to 15% Increase in FEV1 Over the Pre-treatment Value on Day 1	7.5 minutes Interval 3.0 to 33.0	7.0 minutes Interval 3.0 to 35.0	17.0 minutes Interval 4.0 to 37.0	9.5 minutes Interval 4.0 to 37.0	14.0 minutes Interval 4.0 to 34.0

SECONDARY outcome

Timeframe: Onset up to about 40 minutes post-treatment, with duration lasting up to the last assessment of a nominal 6 hour serial spirometry profile (Day 1).

The duration of onset is defined as the time (minutes) of the continual period in which a percentage increase change from baseline in FEV1 of at least 15% is observed. Participants will only be included in the analyses if a percent change from baseline of at least 15% is observed within a nominal 30 minutes post dose assessment. If a participant has multiple periods of onset, only the first will contribute to the summary. Duration of onset can last up to the last assessment during a nominal 6 hour serial spirometry profile. Baseline FEV1 is defined as the average of the 60- and 30- minute pre-dose spirometry taken at randomization.

Outcome measures

Outcome measures
Measure	BDA MDI (PT027) 160/180 μg n=98 Participants Budesonide/Albuterol sulfate BDA MDI (PT027) high dose Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose): Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 160/180 micrograms (μg), given as 2 inhalations of BDA MDI 80/90 μg, four times a day (QID)	BDA MDI (PT027) 80/180 μg n=88 Participants Budesonide/Albuterol sulfate BDA MDI (PT027) low dose Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 80/180 μg (low dose): Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 80/180 micrograms (μg), given as 2 inhalations of BDA MDI 40/90 μg, four times a day (QID)	BD MDI (PT008) 160 µg n=27 Participants Budesonide BD MDI (PT008) Budesonide metered dose inhaler / BD MDI 160 µg: Budesonide pressurized metered dose inhaler (BD MDI) 160 micrograms (μg), given as 2 inhalations of BD MDI 80 μg, four times a day (QID)	AS MDI (PT007) 180 µg n=84 Participants Albuterol sulfate AS MDI (PT007) Albuterol sulfate metered dose inhaler / AS MDI 180 μg: Albuterol sulfate pressurized metered dose inhaler (AS MDI) 180 micrograms (μg), given as 2 inhalations of AS MDI 90 μg, four times a day (QID)	Placebo MDI n=26 Participants Placebo MDI Placebo metered-dose inhaler / Placebo MDI: Placebo pressurized metered dose inhaler (Placebo MDI), given as 2 inhalations of Placebo MDI, four times a day (QID)
Duration of 15% Increase in FEV1 Over the Pre-treatment Value on Day 1	185.5 Minutes Interval 4.0 to 363.0	174 Minutes Interval 10.0 to 362.0	98 Minutes Interval 14.0 to 354.0	158.5 Minutes Interval 9.0 to 363.0	229.5 Minutes Interval 8.0 to 356.0

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: The analysis only includes participants who are uncontrolled at baseline, i.e. ACQ-7 \>= 1.5. All participants who discontinue treatment prior to Week 12 are classified as non-responders.

A responder is defined as a participant who achieves a reduction from baseline in overall ACQ-7 score of at least 0.5. The ACQ-7 has 7 questions, with each question using a 7 point scale, where 0 = totally controlled and 6 = extremely poorly controlled. The overall ACQ-7 score is defined as the averaged score across the 7 questions. The analysis only includes participants who are uncontrolled at basellne, i.e. baseline ACQ-7 \>= 1.5. All participants who discontinue treatment prior to Week 12 are classified as non-responders.

Outcome measures

Outcome measures
Measure	BDA MDI (PT027) 160/180 μg n=161 Participants Budesonide/Albuterol sulfate BDA MDI (PT027) high dose Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose): Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 160/180 micrograms (μg), given as 2 inhalations of BDA MDI 80/90 μg, four times a day (QID)	BDA MDI (PT027) 80/180 μg n=165 Participants Budesonide/Albuterol sulfate BDA MDI (PT027) low dose Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 80/180 μg (low dose): Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 80/180 micrograms (μg), given as 2 inhalations of BDA MDI 40/90 μg, four times a day (QID)	BD MDI (PT008) 160 µg n=162 Participants Budesonide BD MDI (PT008) Budesonide metered dose inhaler / BD MDI 160 µg: Budesonide pressurized metered dose inhaler (BD MDI) 160 micrograms (μg), given as 2 inhalations of BD MDI 80 μg, four times a day (QID)	AS MDI (PT007) 180 µg n=163 Participants Albuterol sulfate AS MDI (PT007) Albuterol sulfate metered dose inhaler / AS MDI 180 μg: Albuterol sulfate pressurized metered dose inhaler (AS MDI) 180 micrograms (μg), given as 2 inhalations of AS MDI 90 μg, four times a day (QID)	Placebo MDI n=159 Participants Placebo MDI Placebo metered-dose inhaler / Placebo MDI: Placebo pressurized metered dose inhaler (Placebo MDI), given as 2 inhalations of Placebo MDI, four times a day (QID)
Number of Participants With a Clinically Meaningful Difference on the Asthma Control Questionnaire 7-item Version (ACQ-7) at Week 12.	107 Participants	108 Participants	100 Participants	77 Participants	88 Participants

SECONDARY outcome

Timeframe: Baseline and 1 week

Trough FEV1 is calculated at each clinic visit as the average of the 60- and 30-minute pre-dose FEV1 measurements. Baseline FEV1 is defined as the average of the 60- and 30-minute pre-dose measures collected on the day of randomization.

Outcome measures

Outcome measures
Measure	BDA MDI (PT027) 160/180 μg n=197 Participants Budesonide/Albuterol sulfate BDA MDI (PT027) high dose Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose): Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 160/180 micrograms (μg), given as 2 inhalations of BDA MDI 80/90 μg, four times a day (QID)	BDA MDI (PT027) 80/180 μg n=198 Participants Budesonide/Albuterol sulfate BDA MDI (PT027) low dose Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 80/180 μg (low dose): Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 80/180 micrograms (μg), given as 2 inhalations of BDA MDI 40/90 μg, four times a day (QID)	BD MDI (PT008) 160 µg n=198 Participants Budesonide BD MDI (PT008) Budesonide metered dose inhaler / BD MDI 160 µg: Budesonide pressurized metered dose inhaler (BD MDI) 160 micrograms (μg), given as 2 inhalations of BD MDI 80 μg, four times a day (QID)	AS MDI (PT007) 180 µg n=192 Participants Albuterol sulfate AS MDI (PT007) Albuterol sulfate metered dose inhaler / AS MDI 180 μg: Albuterol sulfate pressurized metered dose inhaler (AS MDI) 180 micrograms (μg), given as 2 inhalations of AS MDI 90 μg, four times a day (QID)	Placebo MDI n=192 Participants Placebo MDI Placebo metered-dose inhaler / Placebo MDI: Placebo pressurized metered dose inhaler (Placebo MDI), given as 2 inhalations of Placebo MDI, four times a day (QID)
Change From Baseline in Trough FEV1 at Week 1.	107.2 milliliters Standard Error 21.46	72.0 milliliters Standard Error 21.31	93.4 milliliters Standard Error 21.35	-0.8 milliliters Standard Error 21.69	41.3 milliliters Standard Error 21.47

Adverse Events

BDA MDI (PT027) 160/180 μg

Serious events: 2 serious events

Other events: 37 other events

Deaths: 0 deaths

BDA MDI (PT027) 80/180 μg

Serious events: 4 serious events

Other events: 31 other events

Deaths: 0 deaths

BD MDI (PT008) 160 µg

Serious events: 3 serious events

Other events: 31 other events

Deaths: 0 deaths

AS MDI (PT007) 180 µg

Serious events: 1 serious events

Other events: 29 other events

Deaths: 0 deaths

Placebo MDI

Serious events: 3 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BDA MDI (PT027) 160/180 μg n=197 participants at risk Budesonide/Albuterol sulfate BDA MDI (PT027) high dose Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose): Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 160/180 micrograms (μg), given as 2 inhalations of BDA MDI 80/90 μg, four times a day (QID)	BDA MDI (PT027) 80/180 μg n=204 participants at risk Budesonide/Albuterol sulfate BDA MDI (PT027) low dose Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 80/180 μg (low dose): Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 80/180 micrograms (μg), given as 2 inhalations of BDA MDI 40/90 μg, four times a day (QID)	BD MDI (PT008) 160 µg n=199 participants at risk Budesonide BD MDI (PT008) Budesonide metered dose inhaler / BD MDI 160 µg: Budesonide pressurized metered dose inhaler (BD MDI) 160 micrograms (μg), given as 2 inhalations of BD MDI 80 μg, four times a day (QID)	AS MDI (PT007) 180 µg n=201 participants at risk Albuterol sulfate AS MDI (PT007) Albuterol sulfate metered dose inhaler / AS MDI 180 μg: Albuterol sulfate pressurized metered dose inhaler (AS MDI) 180 micrograms (μg), given as 2 inhalations of AS MDI 90 μg, four times a day (QID)	Placebo MDI n=199 participants at risk Placebo MDI Placebo metered-dose inhaler / Placebo MDI: Placebo pressurized metered dose inhaler (Placebo MDI), given as 2 inhalations of Placebo MDI, four times a day (QID)
Infections and infestations COVID-19	0.00% 0/197 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/204 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.50% 1/199 • Number of events 1 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/201 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.50% 1/199 • Number of events 1 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.
Infections and infestations COVID-19 pneumonia	0.00% 0/197 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.49% 1/204 • Number of events 1 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/201 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.
Infections and infestations Sepsis	0.00% 0/197 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/204 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.50% 1/201 • Number of events 1 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.
Cardiac disorders Angina unstable	0.00% 0/197 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/204 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.50% 1/199 • Number of events 1 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/201 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.
Cardiac disorders Myocardial infarction	0.00% 0/197 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.49% 1/204 • Number of events 1 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/201 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.
Vascular disorders Aortic dissection	0.00% 0/197 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/204 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.50% 1/201 • Number of events 1 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/197 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.49% 1/204 • Number of events 1 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/201 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.50% 1/199 • Number of events 1 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.
Gastrointestinal disorders Pancreatitis	0.51% 1/197 • Number of events 1 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/204 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/201 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/197 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/204 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.50% 1/199 • Number of events 1 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/201 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.
Musculoskeletal and connective tissue disorders Metatarsalgia	0.00% 0/197 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/204 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.50% 1/199 • Number of events 1 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/201 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.
General disorders Chest pain	0.51% 1/197 • Number of events 1 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/204 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/201 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.
Investigations Influenza A virus test positive	0.00% 0/197 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/204 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/201 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.50% 1/199 • Number of events 1 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/197 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.49% 1/204 • Number of events 1 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/201 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.

Other adverse events

Other adverse events
Measure	BDA MDI (PT027) 160/180 μg n=197 participants at risk Budesonide/Albuterol sulfate BDA MDI (PT027) high dose Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose): Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 160/180 micrograms (μg), given as 2 inhalations of BDA MDI 80/90 μg, four times a day (QID)	BDA MDI (PT027) 80/180 μg n=204 participants at risk Budesonide/Albuterol sulfate BDA MDI (PT027) low dose Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 80/180 μg (low dose): Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 80/180 micrograms (μg), given as 2 inhalations of BDA MDI 40/90 μg, four times a day (QID)	BD MDI (PT008) 160 µg n=199 participants at risk Budesonide BD MDI (PT008) Budesonide metered dose inhaler / BD MDI 160 µg: Budesonide pressurized metered dose inhaler (BD MDI) 160 micrograms (μg), given as 2 inhalations of BD MDI 80 μg, four times a day (QID)	AS MDI (PT007) 180 µg n=201 participants at risk Albuterol sulfate AS MDI (PT007) Albuterol sulfate metered dose inhaler / AS MDI 180 μg: Albuterol sulfate pressurized metered dose inhaler (AS MDI) 180 micrograms (μg), given as 2 inhalations of AS MDI 90 μg, four times a day (QID)	Placebo MDI n=199 participants at risk Placebo MDI Placebo metered-dose inhaler / Placebo MDI: Placebo pressurized metered dose inhaler (Placebo MDI), given as 2 inhalations of Placebo MDI, four times a day (QID)
Infections and infestations Nasopharyngitis	7.6% 15/197 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	6.4% 13/204 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	5.0% 10/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	4.5% 9/201 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	5.5% 11/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.
Nervous system disorders Headache	5.1% 10/197 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	4.9% 10/204 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	3.5% 7/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	5.5% 11/201 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	7.0% 14/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.
Gastrointestinal disorders Diarrhoea	1.0% 2/197 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.98% 2/204 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	1.0% 2/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	2.0% 4/201 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	2.0% 4/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.
Gastrointestinal disorders Nausea	0.51% 1/197 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.98% 2/204 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	2.5% 5/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/201 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	2.5% 5/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.
Infections and infestations Upper respiratory tract infection	1.0% 2/197 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	1.5% 3/204 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	2.0% 4/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.50% 1/201 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	1.0% 2/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/197 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.98% 2/204 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	1.5% 3/201 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	2.0% 4/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.0% 2/197 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.98% 2/204 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	2.5% 5/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	1.00% 2/201 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.
Vascular disorders Hypertension	2.0% 4/197 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.98% 2/204 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	1.00% 2/201 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	1.0% 2/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.
Infections and infestations COVID-19	1.0% 2/197 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.49% 1/204 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.50% 1/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/201 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	2.0% 4/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.
Respiratory, thoracic and mediastinal disorders Dysphonia	2.0% 4/197 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.49% 1/204 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	1.0% 2/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/201 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.	0.00% 0/199 • Approximately 12 weeks. Adverse events were collected from the time of signed informed consent/assent and up to the safety follow up period. Reported adverse events are those that occurred from the date of first dose of randomized treatment up to the date of treatment discontinuation.

Additional Information

Chief Medical Officer

Avillion LLP

Phone: +44 (0)203 764 9530

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Data or results obtained from this study must not be published without prior approval from the Sponsor.
Publication restrictions are in place

Restriction type: OTHER