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
BREATH
A Phase III, Multicentre, Randomized, Double-blind, Single-Dose, 2-Arm, 2-Period, Crossover Study to Investigate the Efficacy of PT027 Compared With Placebo on Exercise-Induced Bronchoconstriction in Adult Patients With Asthma (BREATH)
1 other identifier
interventional
64
1 country
6
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2023
Shorter than P25 for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2023
CompletedStudy Start
First participant enrolled
December 22, 2023
CompletedFirst Posted
Study publicly available on registry
February 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2024
CompletedResults Posted
Study results publicly available
August 27, 2025
CompletedAugust 27, 2025
July 1, 2025
6 months
December 13, 2023
June 11, 2025
August 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Percentage Fall From Post-dose, Pre-exercise Baseline in Forced Expiratory Volume in 1 Second (FEV₁) Observed up to 60 Minutes Post-exercise Challenge
Lung function was measured by spirometry. Spirometry assessments were completed 5 minutes before dosing, 30 minutes after dosing (baseline; 5 minutes before the exercise challenge), and then 5, 10, 15, 30, and 60 minutes after the exercise challenge. A reduction in FEV₁ was expected due to the effects of asthma and exercise on breathing and lung function. The percentage fall in FEV₁ was calculated based on the baseline value and maximum percentage fall value during the 60-minute assessment period.
Up to 60 minutes post-exercise challenge
Secondary Outcomes (4)
Percentage of Subjects With a Maximum Percentage Fall in FEV₁ Post-exercise Challenge of <10% and <20%
Up to 60 minutes post exercise challenge
Percentage Fall From Post-dose, Pre-exercise Baseline in FEV1 at Each Time Point Within 60 Minutes Post-exercise Challenge
Up to 60 minutes post exercise challenge
Post-Exercise FEV1 Area Under the Curve From 0 to 30 Minutes (AUC0-30min)
Up to 30 minutes post exercise challenge
Time To Recovery
Up to 60 minutes post exercise challenge
Other Outcomes (1)
Number of Participants With Adverse Events (AEs)
Through study completion, an average of 4 weeks
Study Arms (2)
A/B - Treatment with PT027 (BUDESONIDE/ALBUTEROL) 160/180 μg followed by treatment with Placebo
EXPERIMENTALSubjects randomized to receive a single dose of PT027 160/180 μg in treatment Period 1, and a single dose of Placebo in treatment Period 2.
B/A - Treatment with Placebo followed by treatment with PT027 (BUDESONIDE/ALBUTEROL) 160/180 μg
EXPERIMENTALSubjects randomized to receive a single dose of Placebo in treatment Period 1, and a single dose of PT027 160/180 in treatment Period 2.
Interventions
Budesonide/albuterol combination aerosol for inhalation, single dose (given as 2 actuations of 80/90 μg)
Placebo aerosol for inhalation, single dose (given as 2 actuations)
Eligibility Criteria
You may qualify if:
- Female or male aged 18 to 70 years at the time of informed consent.
- Documented history of asthma for at least 6 months prior to Visit 1
- Receiving 1 of the following asthma therapies with stable dosing for at least the 4 weeks before Visit 1 (no other asthma therapies are permitted during the study):
- Short-acting β 2-adrenoreceptor agonist (SABA) used as needed;
- Low- to medium-dose maintenance therapy with inhaled corticosteroid (ICS) and SABA used as needed.
- Demonstrate acceptable MDI administration technique (use of a spacer device during the treatment phase is not permitted)
You may not qualify if:
- Chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, bronchopulmonary dysplasia), including regular or occasional use of oxygen.
- Systemic corticosteroids (SCS) use (any dose and any indication) within 3 months before Visit 1.
- History of life-threatening asthma, defined by past intubations for asthma, or intensive care unit admission for asthma within the prior 24 months.
- Receiving regular maintenance treatment with prohibited anti-inflammatory or long-acting bronchodilator asthma medication (inhaled, nebulized, oral, or systemic) within 1 month prior to Visit 1.
- Unable to tolerate the lung function testing performed after exercise challenge test without use of rescue medication.
- Current smokers, former smokers with \>10 pack-years history, or former smokers who stopped smoking \<6 months before Visit 1 (including all forms of tobacco, e-cigarettes \[vaping\], and marijuana).
- Completed treatment for lower respiratory infection within 6 weeks prior to Visit 1, regardless if resulting in accompanying asthma symptoms aggravation or not.
- Upper respiratory infection involving antibiotic treatment not resolved within 7 days prior to Visit 1.
- Received any marketed (eg, omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab) or investigational biologic within 3 months before Visit 1, or any other prohibited medication.
- Historical or current evidence of a clinically significant disease.
- History of psychiatric disease or intellectual deficiency.
- Having a scheduled or planned hospitalization during the study.
- Inability (and/or unwillingness) to abstain from protocol-defined prohibited medications during the study.
- Use of any herbal products by inhalation or nebulizer within 2 weeks of Visit 1 and/or the unwillingness to stop during the study duration.
- Significant abuse of alcohol or drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (6)
Research Site
Moscow, 105554, Russia
Research Site
Penza, 440067, Russia
Research Site
Perm, 614000, Russia
Research Site
Saint Petersburg, 192071, Russia
Research Site
Saratov, 410054, Russia
Research Site
Ulyanovsk, 432009, Russia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2023
First Posted
February 7, 2024
Study Start
December 22, 2023
Primary Completion
June 29, 2024
Study Completion
June 29, 2024
Last Updated
August 27, 2025
Results First Posted
August 27, 2025
Record last verified: 2025-07