A Phase III, Multicentre, Randomized, Double-blind, Single-Dose, 2-Arm, 2-Period, Crossover Study to Investigate the Efficacy of PT027 Compared With Placebo on Exercise-Induced Bronchoconstriction in Adult Patients With Asthma (BREATH)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 64
- 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
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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):
- •Short-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, bronchopulmonary dysplasia), including regular or occasional use of oxygen.
- •Systemic corticosteroids (SCS) use (any dose and any indication) within 3 months before Visit
- •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
- •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
- •Received any marketed (eg, omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab) or investigational biologic within 3 months before Visit 1, or any other prohibited medication.
- •Historical or current evidence of a clinically significant disease.
- •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.
研究组 & 干预措施
A/B - Treatment with PT027 (BUDESONIDE/ALBUTEROL) 160/180 μg followed by treatment with Placebo
Subjects randomized to receive a single dose of PT027 160/180 μg in treatment Period 1, and a single dose of Placebo in treatment Period 2.
干预措施: Budesonide/albuterol metered-dose inhaler 160/180 μg (Drug)
A/B - Treatment with PT027 (BUDESONIDE/ALBUTEROL) 160/180 μg followed by treatment with Placebo
Subjects randomized to receive a single dose of PT027 160/180 μg in treatment Period 1, and a single dose of Placebo in treatment Period 2.
干预措施: Placebo metered-dose inhaler (Drug)
B/A - Treatment with Placebo followed by treatment with PT027 (BUDESONIDE/ALBUTEROL) 160/180 μg
Subjects randomized to receive a single dose of Placebo in treatment Period 1, and a single dose of PT027 160/180 in treatment Period 2.
干预措施: Budesonide/albuterol metered-dose inhaler 160/180 μg (Drug)
B/A - Treatment with Placebo followed by treatment with PT027 (BUDESONIDE/ALBUTEROL) 160/180 μg
Subjects randomized to receive a single dose of Placebo in treatment Period 1, and a single dose of PT027 160/180 in treatment Period 2.
干预措施: Placebo metered-dose inhaler (Drug)
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% and <20%(Up to 60 minutes post exercise challenge)
- Post-Exercise FEV1 Area Under the Curve From 0 to 30 Minutes (AUC0-30min)(Up to 30 minutes post exercise challenge)
- Percentage Fall From Post-dose, Pre-exercise Baseline in FEV1 at Each Time Point Within 60 Minutes Post-exercise Challenge(Up to 60 minutes post exercise challenge)
- Time To Recovery(Up to 60 minutes post exercise challenge)