Phase 3
Completed N=1,001
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
Asthma
Source: ClinicalTrials.gov NCT03847896 ↗
Enrolled (actual)
1,001
Serious AEs
1.3%
Results posted
Sep 2022
Primary outcomePrimary: 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; 242.2; 178.0; 157.2 milliliters — p=0.025
◆ Published Evidence
Established
22citations · ~7 / year
Albuterol-Budesonide Pressurized Metered Dose Inhaler in Patients With Mild-to-Moderate Asthma: Results of the DENALI Double-Blind Randomized Controlled Trial.
Summary
This is a randomized, double-blind, placebo-controlled, multicenter, parallel group study to compare 2 dose levels of budesonide/albuterol BDA MDI (PT027) to its components budesonide BD MDI (PT008) and albuterol AS MDI (PT007) on improvement in lung function and asthma symptoms after 12 weeks of treatment in adult, adolescent, and child subjects with symptomatic asthma currently being treated with a short/rapid-acting β2-adrenoreceptor agonist (SABA) as needed alone or with low-dose inhaled corticosteroid (ICS) maintenance therapy plus SABA as needed.
Linked Publications
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Albuterol-Budesonide Pressurized Metered Dose Inhaler in Patients With Mild-to-Moderate Asthma: Results of the DENALI Double-Blind Randomized Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
258.6; 242.2; 178.0; 157.2; 96.7 | 0.025 sig |
| PRIMARY Change From Baseline in Trough FEV1 |
135.5; 123.5; 108.9; 2.7; 35.6 | 0.037 sig |
| SECONDARY Time to 15% Increase in FEV1 Over the Pre-treatment Value on Day 1 |
7.5; 7.0; 17.0; 9.5; 14.0 | — |
| SECONDARY Duration of 15% Increase in FEV1 Over the Pre-treatment Value on Day 1 |
185.5; 174; 98; 158.5; 229.5 | — |
| SECONDARY Number of Participants With a Clinically Meaningful Difference on the Asthma Control Questionnaire 7-item Version (ACQ-7) at Week 12. |
107; 108; 100; 77; 88 | 0.118 |
| SECONDARY Change From Baseline in Trough FEV1 at Week 1. |
107.2; 72.0; 93.4; -0.8; 41.3 | 0.169 |
Eligibility Criteria
Inclusion Criteria
- Female or male aged ≥4 years at the time of informed consent
- Physician diagnosis of asthma with a documented history of the last 6 months
- Receiving 1 of the following inhaled asthma medications with stable dosing for at least 30 days prior to Visit 1:
- Only short/rapid-acting β2-adrenoreceptor agonist (SABA) used as needed
- Stable low-dose inhaled corticosteroid in addition to as-needed use of SABA
- Pre-bronchodilator FEV1 of ≥50 to 10 pack-years history, or former smokers who stopped smoking <6 months before Visit 1 (including all forms of tobacco, e-cigarettes [vaping], and marijuana)
- Life-threatening asthma defined as any history of significant asthma episode(s) requiring admission to an intensive care unit, intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s) within 5 years of Visit 1
- Completed treatment for lower respiratory infection within 6 weeks prior to Visit 1
- Upper respiratory infection involving antibiotic treatment not resolved within 7 days prior to Visit 1
- Hospitalizations due to asthma within 6 months prior to Visit 1
- Have taken ≥12 actuations per day of Sponsor-provided Ventolin during the run-in period prior to Visit 2 according to the below criteria:
- ≥2 days out of 14 days of run-in
- ≥3 days out of 15 to 21 days of run-in
- ≥4 days out of 22 or more days of run-in
- Unable to comply with study procedures including non-compliance with diary completion (ie, <70% subject completion of diary assessments in the last 7 days preceding Visit 2 or 4-times daily dosing, <80% compliance during the placebo run-in period).
- Historical or current evidence of a clinically significant disease
- Cancer not in complete remission for at least 5 years before Visit 1
- Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit 1
- History of psychiatric disease, intellectual deficiency, poor motivation, or other conditions if their magnitude is limiting informed consent validity
- Significant abuse of alcohol or drugs, in the opinion of the investigator
Data sourced from ClinicalTrials.gov (NCT03847896) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.