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

Asthma, Exercise-Induced Clinical Trial

— BREATH  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06245551
• Other study ID #: AZ-RU-00004
• Status: Recruiting
• Phase: Phase 3
• Start date: December 22, 2023
• Est. completion date: July 23, 2024

Study information

• Verified date: May 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: July 23, 2024
• Est. primary completion date: July 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 ß 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.

Related Conditions & MeSH terms

• Asthma
• Asthma, Exercise-Induced

Intervention

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)
• Placebo metered-dose inhaler
Placebo aerosol for inhalation, single dose (given as 2 actuations)

Locations

Country	Name	City	State
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Penza
Russian Federation	Research Site	Perm
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	Saratov
Russian Federation	Research Site	Ulyanovsk

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with AEs	The safety profile will be evaluated using vital signs, physical examination, electrocardiograms (ECGs) and adverse event data.	Through study completion, an average of 4 weeks
Primary	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	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
Secondary	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
Secondary	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
Secondary	Time To Recovery, Defined As The Time From Completion Of The Exercise Challenge To The First Measured Post-exercise Challenge FEV1 Value Within 10% Of The Post-dose, Pre-exercise Challenge Baseline FEV1	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