A Study to Assess the Efficacy of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) on Exercise-induced Bronchoconstriction in Adults and Adolescents With Asthma

Exercise Induced Bronchospasm Clinical Trial

— TYREE  

Official title:

A Randomized, Double-blind, Single-dose, 2-Period, Crossover Study to Assess the Efficacy of PT027 Compared With Placebo on Exercise-Induced Bronchoconstriction in Adult and Adolescent Subjects With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04234464
• Other study ID #: AV005
• Status: Completed
• Phase: Phase 3
• Start date: January 15, 2020
• Est. completion date: August 28, 2020

Study information

• Verified date: January 2022
• Source: Bond Avillion 2 Development LP
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, randomized, double-blind, single-dose, placebo-controlled, 2-period, crossover study to evaluate the efficacy and safety of budesonide/albuterol metered-dose inhaler (BDA MDI/PT027) as compared with a placebo metered-dose inhaler (placebo MDI) on exercise-induced bronchoconstriction (EIB) in adult and adolescent subjects with asthma. Subjects will receive each study treatment on separate visits and undergo a treadmill exercise challenge test for up to 10 minutes so that the effect of study treatment on exercise-induced bronchoconstriction can be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 28, 2020
• Est. primary completion date: August 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Female or male aged 12 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/rapid-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, or 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. Current treatment with any investigational product or within the last 30 days of Visit 1.

11. Historical or current evidence of a clinically significant disease

12. Cancer not in complete remission for at least 5 years before Visit 1

13. Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit 1

14. History of psychiatric disease or intellectual deficiency

15. Having a scheduled or planned hospitalization during the study

16. Inability (and/or unwillingness) to abstain from protocol-defined prohibited medications during the study.

17. 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.

18. Significant abuse of alcohol or drugs

Related Conditions & MeSH terms

• Asthma, Exercise-Induced
• Bronchial Spasm
• Exercise Induced Bronchospasm

Intervention

Combination Product:
• Budesonide/albuterol sulfate metered-dose inhaler 160/180 µg
Budesonide/albuterol sulfate combination inhalation aerosol single dose
• Placebo metered-dose inhaler
Placebo inhalation aerosol single dose

Locations

Country	Name	City	State
United States	Research Site	Burke	Virginia
United States	Research Site	Denver	Colorado
United States	Research Site	North Dartmouth	Massachusetts
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Skillman	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bond Avillion 2 Development LP

Country where clinical trial is conducted

United States, 

References & Publications (1)

LaForce C, Chipps BE, Albers FC, Reilly L, Johnsson E, Andrews H, Cappelletti C, Maes A, Papi A. Albuterol/budesonide for the treatment of exercise-induced bronchoconstriction in patients with asthma: The TYREE study. Ann Allergy Asthma Immunol. 2021 Oct — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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%	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% was determined.	Up to 60 minutes post exercise challenge