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

Completed · Phase 3 · Has a placebo group

Conditions studied: Exercise Induced Bronchospasm

In brief

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.

Key facts

Study ID: NCT04234464
Run by: Bond Avillion 2 Development LP
People needed: 60
Starts: 2020-01-15
Expected to finish: 2020-08-28
Last updated by the study team: 2022-01-13

Who can join

Age: 12 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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
Inability (and/or unwillingness) to abstain from protocol-defined prohibited medications during the study.
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.
Significant abuse of alcohol or drugs

Where it is running

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

Full record on ClinicalTrials.gov

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