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Bronchodilator

Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg for 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

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.

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

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
~464 spots leftby Sep 2025
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