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Bronchodilator

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)

Phase 3
Waitlist Available
Research Sponsored by Bond Avillion 2 Development LP
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization up to discontinuation of randomized treatment or a change in maintenance therapy. the mean and median reporting period for all participants was 44 and 48 weeks, respectively.
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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.

Eligible Conditions
  • Asthma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization up to discontinuation of randomized treatment or a change in maintenance therapy. the mean and median reporting period for all participants was 44 and 48 weeks, respectively.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization up to discontinuation of randomized treatment or a change in maintenance therapy. the mean and median reporting period for all participants was 44 and 48 weeks, respectively. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With a Severe Asthma Exacerbation Event
Secondary study objectives
Annualized Severe Exacerbation Rate
Asthma Control Questionnaire-5 (ACQ-5) - Number of Participants Who Were Responders at Week 24
Asthma Quality of Life Questionnaire for Participants Aged 12 Years and Older (AQLQ+12) - Number of Participants Who Were Responders at Week 24
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg
2018
Completed Phase 3
~3140
Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg
2018
Completed Phase 3
~3200

Find a Location

Who is running the clinical trial?

Bond Avillion 2 Development LPLead Sponsor
5 Previous Clinical Trials
3,903 Total Patients Enrolled
3 Trials studying Asthma
3,530 Patients Enrolled for Asthma
Frank Albers, MD, PhDStudy DirectorAvillion LLP
3 Previous Clinical Trials
1,073 Total Patients Enrolled
2 Trials studying Asthma
1,013 Patients Enrolled for Asthma
~447 spots leftby Jan 2026
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