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A Study to Investigate the Effects of PT027 (Budesonide/Albuterol Sulfate) Metered-dose Inhaler Compared With Placebo on Exercise-Induced Bronchoconstriction in Adult Patients With Asthma

NCT06245551 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-08-27

Study results available
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Summary

The purpose of this Phase III, multicentre, randomized, double-blind, single-dose, 2-period, crossover study is to assess the efficacy and safety of PT027 (budesonide/albuterol sulfate) metered-dose inhaler compared with placebo on exercise-induced bronchoconstriction in adult patients with asthma. Subjects will receive each study treatment on separate visits and undergo a treadmill exercise challenge test so that the effect of study treatment on exercise-induced bronchoconstriction can be evaluated

Conditions

  • Asthma, Exercise-Induced

Interventions

DRUG

Budesonide/albuterol metered-dose inhaler 160/180 μg

Budesonide/albuterol combination aerosol for inhalation, single dose (given as 2 actuations of 80/90 μg)

DRUG

Placebo metered-dose inhaler

Placebo aerosol for inhalation, single dose (given as 2 actuations)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2023-12-22
Primary Completion
2024-06-29
Completion
2024-06-29
FDA Drug
Yes

Countries

  • Russia

Study Locations

More Related Trials

Entities

Companies

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 NCT06245551 on ClinicalTrials.gov