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
TYREE
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
1 other identifier
interventional
60
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2020
Shorter than P25 for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2020
CompletedFirst Submitted
Initial submission to the registry
January 16, 2020
CompletedFirst Posted
Study publicly available on registry
January 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2020
CompletedResults Posted
Study results publicly available
December 30, 2021
CompletedJanuary 13, 2022
January 1, 2022
8 months
January 16, 2020
November 1, 2021
January 4, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Percentage of Subjects With a Maximum Percentage Fall in FEV₁ Post-exercise Challenge of <10%
Up to 60 minutes post exercise challenge
Study Arms (2)
A/B - Treatment with BDA MDI 160/180 followed by treatment with Placebo MDI
EXPERIMENTALSubjects randomized to receive a single dose of BDA MDI 160/180 in treatment period 1, and a single dose of Placebo MDI in treatment period 2.
B/A - Treatment with Placebo MDI followed by treatment with BDA MDI 160/180
EXPERIMENTALSubjects randomized to receive a single dose of Placebo MDI in treatment period 1, and a single dose of BDA MDI 160/180 in treatment period 2.
Interventions
Budesonide/albuterol sulfate combination inhalation aerosol single dose
Placebo inhalation aerosol single dose
Eligibility Criteria
You may qualify if:
- Female or male aged 12 to 70 years at the time of informed consent
- Documented history of asthma for at least 6 months prior to Visit 1
- 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 β 2-adrenoreceptor agonist (SABA) used as needed
- Low- to medium-dose maintenance therapy with inhaled corticosteroid (ICS) and SABA used as needed
- Demonstrate acceptable MDI administration technique (use of a spacer device during the treatment phase is not permitted)
You may not qualify if:
- 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
- Systemic corticosteroids (SCS) use (any dose and any indication) within 3 months before Visit 1
- History of life-threatening asthma, defined by past intubations for asthma, or intensive care unit admission for asthma within the prior 24 months
- 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
- Unable to tolerate the lung function testing performed after exercise challenge test without use of rescue medication
- 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)
- Completed treatment for lower respiratory infection within 6 weeks prior to Visit 1, regardless if resulting in accompanying asthma symptoms aggravation or not
- Upper respiratory infection involving antibiotic treatment not resolved within 7 days prior to Visit 1
- Received any marketed (eg, omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab) or investigational biologic within 3 months before Visit 1, or any other prohibited medication
- Current treatment with any investigational product or within the last 30 days of Visit 1.
- Historical or current evidence of a clinically significant disease
- Cancer not in complete remission for at least 5 years before Visit 1
- Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit 1
- History of psychiatric disease or intellectual deficiency
- Having a scheduled or planned hospitalization during the study
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Research Site
Denver, Colorado, 80230, United States
Research Site
North Dartmouth, Massachusetts, 02747, United States
Research Site
St Louis, Missouri, 63109, United States
Research Site
Skillman, New Jersey, 08558, United States
Research Site
Raleigh, North Carolina, 27607, United States
Research Site
Burke, Virginia, 22015, United States
Related 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. 2022 Feb;128(2):169-177. doi: 10.1016/j.anai.2021.10.020. Epub 2021 Oct 24.
PMID: 34699967RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Avillion LLP
Study Officials
- STUDY DIRECTOR
Frank Albers, MD, PhD
Avillion LLP
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2020
First Posted
January 21, 2020
Study Start
January 15, 2020
Primary Completion
August 28, 2020
Study Completion
August 28, 2020
Last Updated
January 13, 2022
Results First Posted
December 30, 2021
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share