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
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Exercise Induced Bronchospasm
- 发起方
- Bond Avillion 2 Development LP
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 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
- 状态
- 已完成
- 最后更新
- 4年前
概览
简要总结
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.
研究者
入排标准
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
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
时间窗: 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.
次要结局
- Percentage of Subjects With a Maximum Percentage Fall in FEV₁ Post-exercise Challenge of <10%(Up to 60 minutes post exercise challenge)