Phase 3
Completed 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
Source: ClinicalTrials.gov NCT03769090 ↗Enrolled (actual)
3,132
Serious AEs
4.5%
Results posted
Sep 2022
Primary outcomePrimary: Number of Participants With a Severe Asthma Exacerbation Event — 207; 266; 241; 276 Participants — p=<0.001
◆ Published Evidence
Highly cited
123citations · ~31 / year
Albuterol-Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma.
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.
Linked Publications (4)
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Albuterol-Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma.
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Efficacy and safety of as-needed albuterol/budesonide versus albuterol in adults and children aged ≥4 years with moderate-to-severe asthma: rationale and design of the randomised, double-blind, active-controlled MANDALA study.
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Increased versus stable doses of inhaled corticosteroids for exacerbations of chronic asthma in adults and children.
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Albuterol-budesonide rescue inhaler for asthma: Patterns of use and safety in the MANDALA trial.
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 |
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) 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.