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A Study to Assess the Efficacy of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) on Exercise-induced Bronchoconstriction in Adults and Adolescents With Asthma

NCT04234464 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-01-13

Study results available
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Summary

This is a multicenter, randomized, double-blind, single-dose, placebo-controlled, 2-period, crossover study to evaluate the efficacy and safety of budesonide/albuterol metered-dose inhaler (BDA MDI/PT027) as compared with a placebo metered-dose inhaler (placebo MDI) on exercise-induced bronchoconstriction (EIB) in adult and adolescent subjects with asthma. Subjects will receive each study treatment on separate visits and undergo a treadmill exercise challenge test for up to 10 minutes so that the effect of study treatment on exercise-induced bronchoconstriction can be evaluated.

Conditions

  • Exercise Induced Bronchospasm

Interventions

COMBINATION_PRODUCT

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

Budesonide/albuterol sulfate combination inhalation aerosol single dose

COMBINATION_PRODUCT

Placebo metered-dose inhaler

Placebo inhalation aerosol single dose

Sponsors & Collaborators

  • Bond Avillion 2 Development LP

    lead INDUSTRY

Principal Investigators

  • Frank Albers, MD, PhD · Avillion LLP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-15
Primary Completion
2020-08-28
Completion
2020-08-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04234464 on ClinicalTrials.gov