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
NCT ID: NCT04234464
Last Updated: 2022-01-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
60 participants
INTERVENTIONAL
2020-01-15
2020-08-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) in Adults and Children 4 Years of Age or Older With Asthma
NCT03769090
A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered Dose Inhaler (BDA MDI/PT027) Used 4 Times Daily in Adults and Children 4 Years of Age or Older With Asthma
NCT03847896
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
NCT06245551
A Study to Investigate the Effect on Lung Function of BDA Formulated With a Next Generation Propellant Compared With an Approved Asthma Treatment (BDA With HFA Propellant) in Participants With Asthma
NCT06502366
Study to Assess the Efficacy and Safety of Budesonide (PT008) in Adult Subjects With Mild to Moderate Persistent Asthma
NCT02105012
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A/B - Treatment with BDA MDI 160/180 followed by treatment with Placebo MDI
Subjects 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.
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
B/A - Treatment with Placebo MDI followed by treatment with BDA MDI 160/180
Subjects 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.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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 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
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
12 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bond Avillion 2 Development LP
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Frank Albers, MD, PhD
Role: STUDY_DIRECTOR
Avillion LLP
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Denver, Colorado, United States
Research Site
North Dartmouth, Massachusetts, United States
Research Site
St Louis, Missouri, United States
Research Site
Skillman, New Jersey, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Burke, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AV005
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.