An 8 Week, Randomized, Double-Blind, Parallel Group, Multicenter Trial Comparing the Efficacy and Safety of Oral IPL512,602 to Placebo in Subjects With Moderate to Severe Persistent Asthma Inadequately Controlled on Inhaled Corticosteroids
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 16
- 主要终点
- Change in AQLQ(S) overall scores from baseline to 8 weeks post-randomization
研究概览
简要总结
The purpose of the study is to determine whether IPL512,602 is safe and effective for the treatment of asthma symptoms in patients who remain symptomatic on a background therapy of inhaled corticosteroids.
详细描述
This multicenter, randomized, double-blind, placebo-controlled, parallel group study will include subjects with persistent moderate to severe asthma who require inhaled corticosteroids and inhaled short-acting β2-agonists (SABAs). Subjects who pass screening at Visit 1 will enter a 2-3 week baseline period to confirm stable asthma symptoms and collect baseline data. Subjects will continue with ongoing prescribed treatment during this period, or as modified by the investigator based on clinical judgment. Subjects will use the SABA prescribed for them to alleviate asthma symptoms on an as needed basis throughout the study. If eligible, at Visit 2 subjects will be randomized to treatment with either IPL512,602 (20 mg) daily or placebo in a 1:1 ratio. Randomization in each treatment group will be stratified into two subgroups: those receiving low to medium doses of inhaled corticosteroids (≤500 µg per day fluticasone or equivalent) and those receiving high doses of inhaled corticosteroids (>500 µg per day fluticasone or equivalent). During the 8-week treatment period, subjects will return to the clinic after 1, 2, 4, 6, and 8 weeks of treatment (Visits 3-7). Adverse event data will be collected for 14 days following the last dose administration (Visit 8).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a history of persistent asthma for at least the 4 months prior to entry
- •require daily inhaled corticosteroids (220-1000 µg fluticasone equivalent per day) for at least 4 weeks prior to randomization and short-acting beta-2-agonist (SABA)
- •FEV1 at randomization (without exposure to a SABA for at least 6 hours) must be between 50% and 80% of predicted normal
- •reversibility of FEV1 by at least 12% and at least 250 mL following two to four inhalations of a SABA must be demonstrated prior to randomization
- •AQLQ(S) score of 4.5 or less at both the screening (Visit 1) and randomization (Visit 2) visits
- •patients must meet at least two out of three of the following criteria:
- •overall score minimum of 2 on Asthma Control Questionnaire (ACQ)
- •require rescue SABA use of 2 or more inhalations per day for symptom relief on at least 4 of 7 days during each week of the baseline period
- •nighttime awakenings due to asthma, an average of at least once a week during the baseline period
排除标准
- •history of chronic pulmonary diseases other than asthma, including bronchitis, chronic obstructive pulmonary disease (COPD), emphysema, cystic fibrosis, pulmonary tuberculosis, or bronchiectasis
- •other asthma therapies:
- •use of long-acting beta-2-agonists within 5 weeks prior to randomization
- •use of leukotriene modulators, theophylline, or muscarinic antagonists within 4 weeks prior to randomization
- •use of injectable or oral corticosteroids within 2 months prior to screening
- •requirement for more than 10 inhalations per day of a short-acting beta-2-agonist more than 3 times per week during the baseline period
结局指标
主要结局
Change in AQLQ(S) overall scores from baseline to 8 weeks post-randomization
次要结局
- Change in AQLQ(S) individual domain scores
- Change in asthma control
- Change in FEV1
- Change in morning and evening PEFR
- Change in SABA usage
- Change in nighttime awakenings
- Total number of asthma worsening events
- Change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)