A Study to Investigate the Effects of PT027 (Budesonide/Albuterol Sulfate) Metered-dose Inhaler C… (NCT06245551) | Clinical Trial Compass
CompletedPhase 3
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
Russia64 participantsStarted 2023-12-22
Plain-language 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
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Female or male aged 18 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):
✓. Demonstrate acceptable MDI administration technique (use of a spacer device during the treatment phase is not permitted)
Exclusion criteria
✕. 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.
✕. 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.
What they're measuring
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
Timeframe: Up to 60 minutes post-exercise challenge
✕. 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.