Phase 3
N=3,132
A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) in Adults and Children 4 Years of Age or Older With Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT03769090 ↗Enrolled (actual)
3,132
Serious AEs
4.5%
Results posted
Sep 2022
Primary outcome: Primary: Number of Participants With a Severe Asthma Exacerbation Event — 207; 266; 241; 276 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg (Combination_product); Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg (Combination_product); Albuterol sulfate metered-dose inhaler 180 μg (Drug)
- Age
- Pediatric, Adult, Older Adult · 4+ yrs
- Sex
- All
- Sponsor
- Bond Avillion 2 Development LP
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Severe Asthma Exacerbation Event |
207; 266; 241; 276 | <0.001 sig |
| SECONDARY Annualized Severe Exacerbation Rate |
0.45; 0.59; 0.49; 0.61 | 0.008 sig |
| SECONDARY Total Annualized Dose of Systemic Corticosteroid (SCS) |
86.2; 129.3; 95.5; 127.1 | 0.002 sig |
| SECONDARY Asthma Control Questionnaire-5 (ACQ-5) - Number of Participants Who Were Responders at Week 24 |
677; 630; 681; 650 | 0.033 sig |
| SECONDARY Asthma Quality of Life Questionnaire for Participants Aged 12 Years and Older (AQLQ+12) - Number of Participants Who Were Responders at Week 24 |
508; 489; 461 | 0.028 sig |
Summary
This is a randomized, double-blind, multicenter, parallel-group, variable-length study to compare 2 doses of BDA MDI (PT027) with AS MDI (PT007) on the time to first severe asthma exacerbation in adult, adolescent, and pediatric subjects with moderate to severe asthma.
Eligibility Criteria
Inclusion Criteria
- Female or male aged ≥4 years at the time of informed consent
- Physician diagnosis of asthma documented for at least 1 year
- Receiving 1 of the following scheduled asthma maintenance therapies for 3 months with stable dosing for at least the last 4 weeks before Visit 1:
- Medium-to-high-dose inhaled corticosteroid (ICS)
- Medium-to-high-dose ICS and 1 additional maintenance therapy from the following: leukotriene receptor antagonists (LTRA), long-acting muscarinic antagonists (LAMA), or theophylline
- Low-to-high-dose ICS in combination with long-acting β2-adrenoreceptor agonist (LABA) with or without one additional maintenance therapy from the following: LTRA, LAMA, or theophylline
- Prebronchodilator forced expiratory volume in 1 second (FEV1) of ≥40 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 intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s) within 5 years of Visit 1
- Historical or current evidence of a clinically significant disease
- Cancer not in complete remission for at least 5 years
- 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
Data sourced from ClinicalTrials.gov (NCT03769090). 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.