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)

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

Study Overview

• Status: Completed
• Conditions: Asthma, Exercise-Induced
• Intervention / Treatment: Drug: Budesonide/albuterol metered-dose inhaler 160/180 μg; Drug: Placebo metered-dose inhaler

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russia
  • Moscow, Russia, 105554
    • Research Site
  • Penza, Russia, 440067
    • Research Site
  • Perm, Russia, 614000
    • Research Site
  • Saint Petersburg, Russia, 192071
    • Research Site
  • Saratov, Russia, 410054
    • Research Site
  • Ulyanovsk, Russia, 432009
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Female or male aged 18 to 70 years at the time of informed consent.
2. Documented history of asthma for at least 6 months prior to Visit 1

3. 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.
4. Demonstrate acceptable MDI administration technique (use of a spacer device during the treatment phase is not permitted)

Exclusion Criteria:

1. 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.
2. Systemic corticosteroids (SCS) use (any dose and any indication) within 3 months before Visit 1.
3. History of life-threatening asthma, defined by past intubations for asthma, or intensive care unit admission for asthma within the prior 24 months.
4. 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.
5. Unable to tolerate the lung function testing performed after exercise challenge test without use of rescue medication.
6. 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).
7. Completed treatment for lower respiratory infection within 6 weeks prior to Visit 1, regardless if resulting in accompanying asthma symptoms aggravation or not.
8. Upper respiratory infection involving antibiotic treatment not resolved within 7 days prior to Visit 1.
9. Received any marketed (eg, omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab) or investigational biologic within 3 months before Visit 1, or any other prohibited medication.
10. Historical or current evidence of a clinically significant disease.
11. History of psychiatric disease or intellectual deficiency.
12. Having a scheduled or planned hospitalization during the study.
13. Inability (and/or unwillingness) to abstain from protocol-defined prohibited medications during the study.
14. 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.
15. Significant abuse of alcohol or drugs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A/B - Treatment with PT027 (BUDESONIDE/ALBUTEROL) 160/180 μg followed by treatment with Placebo; Subjects 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.	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); Other Names: PT027 (BDA MDI) 160/180 μg; Drug: Placebo metered-dose inhaler; Placebo aerosol for inhalation, single dose (given as 2 actuations); Other Names: Placebo MDI
Experimental: B/A - Treatment with Placebo followed by treatment with PT027 (BUDESONIDE/ALBUTEROL) 160/180 μg; Subjects randomized to receive a single dose of Placebo in treatment Period 1, and a single dose of PT027 160/180 in treatment Period 2.	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); Other Names: PT027 (BDA MDI) 160/180 μg; Drug: Placebo metered-dose inhaler; Placebo aerosol for inhalation, single dose (given as 2 actuations); Other Names: Placebo MDI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With a Maximum Percentage Fall in FEV₁ Post-exercise Challenge of <10% and <20%	The percentage fall in FEV₁ was calculated based on the baseline value and maximum percentage fall value during the 60-minute assessment period, and the percentage of subjects with a maximum percentage fall <10% and <20% was determined	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	The percentage fall in FEV₁ at each time point was calculated based on the baseline value and percentage fall value during the 60-minute assessment period at each time point.	Up to 60 minutes post exercise challenge
Post-Exercise FEV1 Area Under the Curve From 0 to 30 Minutes (AUC0-30min)	FEV1 AUC0-30min will be derived for the changes from the post-dose, pre-exercise baseline using the trapezoidal rule and will be normalized by dividing by the actual time (in minutes) from dosing to the last included measurement, scheduled at 30 minutes post-exercise challenge.	Up to 30 minutes post exercise challenge
Time To Recovery	Time to recovery will be derived as the time (minutes) post-exercise challenge in which the FEV1 result returns to within 10% of the value recorded at the post-dose, pre-exercise baseline.	Up to 60 minutes post exercise challenge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events (AEs)	The safety profile will be evaluated using vital signs, physical examination, electrocardiograms (ECGs) and AE data.	Through study completion, an average of 4 weeks

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• AZ-RU-00004_CSP_Redacted
• AZ-RU-00004_Statistical Analysis Plan_Redacted
• AZ-RU-00004_CSR Synopsis_Redacted

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2023
• Primary Completion (Actual): June 29, 2024
• Study Completion (Actual): June 29, 2024

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Estimated): August 27, 2025
• Last Update Submitted That Met QC Criteria: August 8, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Asthma; Anti-Inflammatory Agents; Bronchodilator Agents; Budesonide; Albuterol; Bronchial Spasm; Exercise-Induced Allergies
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Asthma, Exercise-Induced; Bronchial Spasm; Exercise-Induced Allergies; Polycyclic Compounds; Pregnanes; Steroids; Fused-Ring Compounds; Pregnenediones; Pregnenes; Budesonide
• Other Study ID Numbers: AZ-RU-00004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes