Status:
COMPLETED
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
Lead Sponsor:
Bond Avillion 2 Development LP
Conditions:
Asthma
Eligibility:
All Genders
4+ years
Phase:
PHASE3
Brief 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) a...
Eligibility Criteria
Inclusion
- 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 \<85% predicted normal value for adults (≥18 years of age) and ≥50% predicted normal value for subjects aged 4 to 17 years after withholding SABA ≥6 hours at Visit 1.
- Demonstrate reversibility of airflow limitation defined as a ≥15% increase in FEV1 relative to baseline after administration of Sponsor-provided SABA (Ventolin) at either Visit 1 or Visit 1a.
- Demonstrate acceptable spirometry performance acceptability/repeatability criteria
- Taken Ventolin on ≥2 days out of 7 days prior to Visit 2
- Demonstrate acceptable metered dose inhaler (MDI) administration technique as assessed by the investigator.
- Able to perform acceptable and reproducible peak expiratory flow measurements as assessed by the investigator
Exclusion
- Chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia)
- Systemic corticosteroids (SCS) use (any dose and any indication) within 3 months before Visit 1
- Chronic (≥3 weeks) use of SCS within 6 months prior to Visit 1
- Received any marketed (eg, omalizumab, mepolizumab, reslizumab, benralizumab) or investigational biologic within 3 months or 5 half-lives before Visit 1, whichever is longer, or any other prohibited medication
- Current smokers, former smokers with \>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
Key Trial Info
Start Date :
March 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2021
Estimated Enrollment :
1001 Patients enrolled
Trial Details
Trial ID
NCT03847896
Start Date
March 20 2019
End Date
July 20 2021
Last Update
April 13 2023
Active Locations (129)
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1
Research Site
Mobile, Alabama, United States, 36608
2
Research Site
Bakersfield, California, United States, 93301
3
Research Site
Costa Mesa, California, United States, 92627
4
Research Site
Encinitas, California, United States, 92024