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

Phase 3

Completed

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

• Registration Number: NCT06245551
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-13
• Study Start: 2023-12-22
• Study First Submitted QC: 2024-01-29
• Study First Posted: 2024-02-07
• Primary Completion: 2024-06-29
• Study Completion: 2024-06-29
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A/B - Treatment with PT027 (BUDESONIDE/ALBUTEROL) 160/180 μg followed by treatment with Placebo	Budesonide/albuterol metered-dose inhaler 160/180 μg	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.
A/B - Treatment with PT027 (BUDESONIDE/ALBUTEROL) 160/180 μg followed by treatment with Placebo	Placebo metered-dose inhaler	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.
B/A - Treatment with Placebo followed by treatment with PT027 (BUDESONIDE/ALBUTEROL) 160/180 μg	Budesonide/albuterol metered-dose inhaler 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.
B/A - Treatment with Placebo followed by treatment with PT027 (BUDESONIDE/ALBUTEROL) 160/180 μg	Placebo metered-dose inhaler	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.

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects With a Maximum Percentage Fall in FEV₁ Post-exercise Challenge of <10% and <20%	Up to 60 minutes post exercise challenge	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
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	Up to 60 minutes post exercise challenge	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.
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	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.
Post-Exercise FEV1 Area Under the Curve from 0 to 30 Minutes (AUC0-30min)	Up to 30 minutes post exercise challenge	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.

Trial Locations

Locations (1)

Research Site; 🇷🇺 Ulyanovsk, Russian Federation