Trial · NCT03847896
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
NCT03847896, Phase 3, Completed, Bond Avillion 2 Development LP; results first posted 2022-09-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT03847896. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03847896
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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 number
- NCT03847896
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,001 participants, actual
- Lead sponsor
- Bond Avillion 2 Development LP
- Conditions
- Asthma
- Interventions
Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose), Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 80/180 μg (low dose), Budesonide metered dose inhaler / BD MDI 160 µg, Albuterol sulfate metered dose inhaler / AS MDI 180 μg, Placebo metered-dose inhaler / Placebo MDI
- First posted
- 2019-02-20
- Last updated
- 2023-04-13
- Other registries' IDs
- eudract:2018-003674-27
- Results first posted
- 2022-09-30
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Baseline and 12 weeks | 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). |
| Primary | Change From Baseline in Trough FEV1 | 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. |
| Secondary | Time to 15% Increase in FEV1 Over the Pre-treatment Value on Day 1 | From first dose (first inhalation of randomized treatment) up to about 40 minutes post-dose (Day 1). | 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. |
| Secondary | Duration of 15% Increase in FEV1 Over the Pre-treatment Value on Day 1 | 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. |
| Secondary | Number of Participants With a Clinically Meaningful Difference on the Asthma Control Questionnaire 7-item Version (ACQ-7) at Week 12. | Baseline and 12 weeks | 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. |
| Secondary | Change From Baseline in Trough FEV1 at Week 1. | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Baseline and 12 weeks | milliliters | LEAST_SQUARES_MEAN | |
| PRIMARY | Change From Baseline in Trough FEV1 | Baseline and 12 weeks | milliliters | LEAST_SQUARES_MEAN | |
| SECONDARY | Time to 15% Increase in FEV1 Over the Pre-treatment Value on Day 1 | From first dose (first inhalation of randomized treatment) up to about 40 minutes post-dose (Day 1). | 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. | minutes | MEDIAN |
| SECONDARY | Duration of 15% Increase in FEV1 Over the Pre-treatment Value on Day 1 | 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). | Minutes | MEDIAN | |
| SECONDARY | Number of Participants With a Clinically Meaningful Difference on the Asthma Control Questionnaire 7-item Version (ACQ-7) at Week 12. | Baseline and 12 weeks | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Trough FEV1 at Week 1. | Baseline and 1 week | milliliters | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | BDA MDI (PT027) 160/180 μg | 258.6 | Standard Error 18.87 | milliliters | |
| 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 | BDA MDI (PT027) 80/180 μg | 242.2 | Standard Error 18.80 | milliliters | |
| 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 | BD MDI (PT008) 160 µg | 178.0 | Standard Error 18.79 | milliliters | |
| 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 | AS MDI (PT007) 180 µg | 157.2 | Standard Error 19.08 | milliliters | |
| 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 | Placebo MDI | 96.7 | Standard Error 19.02 | milliliters | |
| Change From Baseline in Trough FEV1 | BDA MDI (PT027) 160/180 μg | 135.5 | Standard Error 24.58 | milliliters | |
| Change From Baseline in Trough FEV1 | BDA MDI (PT027) 80/180 μg | 123.5 | Standard Error 24.65 | milliliters | |
| Change From Baseline in Trough FEV1 | BD MDI (PT008) 160 µg | 108.9 | Standard Error 24.51 | milliliters | |
| Change From Baseline in Trough FEV1 | AS MDI (PT007) 180 µg | 2.7 | Standard Error 25.24 | milliliters | |
| Change From Baseline in Trough FEV1 | Placebo MDI | 35.6 | Standard Error 25.12 | milliliters |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BDA MDI (PT027) 160/180 μg | 197 | |
| Overall Study | STARTED | BDA MDI (PT027) 80/180 μg | 204 | |
| Overall Study | STARTED | BD MDI (PT008) 160 µg | 200 | |
| Overall Study | STARTED | AS MDI (PT007) 180 µg | 201 | |
| Overall Study | STARTED | Placebo MDI | 199 | |
| Overall Study | COMPLETED | BDA MDI (PT027) 160/180 μg | 190 | |
| Overall Study | COMPLETED | BDA MDI (PT027) 80/180 μg | 188 | |
| Overall Study | COMPLETED | BD MDI (PT008) 160 µg | 188 | |
| Overall Study | COMPLETED | AS MDI (PT007) 180 µg | 184 | |
| Overall Study | COMPLETED | Placebo MDI | 178 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events115
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | BDA MDI (PT027) 160/180 μg | 15 | 197 | |
| other | Nasopharyngitis | Infections and infestations | BDA MDI (PT027) 80/180 μg | 13 | 204 | |
| other | Nasopharyngitis | Infections and infestations | BD MDI (PT008) 160 µg | 10 | 199 | |
| other | Nasopharyngitis | Infections and infestations | AS MDI (PT007) 180 µg | 9 | 201 | |
| other | Nasopharyngitis | Infections and infestations | Placebo MDI | 11 | 199 | |
| other | Headache | Nervous system disorders | BDA MDI (PT027) 160/180 μg | 10 | 197 | |
| other | Headache | Nervous system disorders | BDA MDI (PT027) 80/180 μg | 10 | 204 | |
| other | Headache | Nervous system disorders | BD MDI (PT008) 160 µg | 7 | 199 | |
| other | Headache | Nervous system disorders | AS MDI (PT007) 180 µg | 11 | 201 | |
| other | Headache | Nervous system disorders | Placebo MDI | 14 | 199 |
1 to 10 of 115Source ClinicalTrials.gov
See all 115 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BDA MDI (PT027) 160/180 μg | 0 | 197 |
| Total, all-cause mortality | BDA MDI (PT027) 80/180 μg | 0 | 204 |
| Total, all-cause mortality | BD MDI (PT008) 160 µg | 0 | 199 |
| Total, all-cause mortality | AS MDI (PT007) 180 µg | 0 | 201 |
| Total, all-cause mortality | Placebo MDI | 0 | 199 |
| Total, other adverse events | BDA MDI (PT027) 160/180 μg | 37 | 197 |
| Total, other adverse events | BDA MDI (PT027) 80/180 μg | 31 | 204 |
| Total, other adverse events | BD MDI (PT008) 160 µg | 31 | 199 |
| Total, other adverse events | AS MDI (PT007) 180 µg | 29 | 201 |
| Total, other adverse events | Placebo MDI | 38 | 199 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37003355 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03847896
GET https://conductscience.org/api/trials/v1/NCT03847896/results?page=2