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
(MANDALA Trial)
Recruiting in Palo Alto (17 mi)
+288 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Bond Avillion 2 Development LP
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?
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
Medium-to-high-dose inhaled corticosteroid (ICS)
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Treatment Details
Interventions
- Albuterol sulfate (Bronchodilator)
- Budesonide (Corticosteroid)
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: BDA MDI (PT027) 80/180 μgExperimental Treatment1 Intervention
Budesonide/albuterol sulfate, BDA MDI, PT027 low dose
Group II: BDA MDI (PT027) 160/180 μgExperimental Treatment1 Intervention
Budesonide/albuterol sulfate, BDA MDI, PT027 high dose
Group III: AS MDI (PT007) 180 µgActive Control1 Intervention
Albuterol sulfate MDI, PT007
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Research SiteLittle Rock, AR
Research SiteBakersfield, CA
Research SiteCape Coral, FL
Research SiteYpsilanti, MI
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Who Is Running the Clinical Trial?
Bond Avillion 2 Development LPLead Sponsor