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

Study identifier:AZ-RU-00004

ClinicalTrials.gov identifier:NCT06245551

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

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)

Medical condition

Asthma, Exercise-Induced

Phase

Phase 3

Healthy volunteers

Study drug

Budesonide/albuterol metered-dose inhaler 160/180 μg, Placebo metered-dose inhaler

Sex

All

Estimated Enrollment

Study type

Interventional

Age

18 Years - 70 Years

Date

Study Start Date: 22 Dec 2023

Estimated Primary Completion Date: 23 Jul 2024

Estimated Study Completion Date: 23 Jul 2024

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2024 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

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.

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Arms	Assigned Interventions
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 Name: PT027 (BDA MDI) 160/180 μg Drug: Placebo metered-dose inhaler Placebo aerosol for inhalation, single dose (given as 2 actuations) Other Name: 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 Name: PT027 (BDA MDI) 160/180 μg Drug: Placebo metered-dose inhaler Placebo aerosol for inhalation, single dose (given as 2 actuations) Other Name: Placebo MDI

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]