A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-03715455 ADMINISTERED TWICE DAILY BY INHALATION FOR 12 WEEKS IN SUBJECTS WITH PERSISTENT MODERATE TO SEVERE ASTHMA WHO REMAIN UNCONTROLLED DESPITE TREATMENT WITH INHALED CORTICOSTEROIDS (ICS) AND LONG-ACTING BETA2 AGONISTS (LABA)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 51
- 试验地点
- 28
- 主要终点
- Percentage of Participants With Asthma Worsening Events
研究概览
简要总结
The study proposes to evaluate the safety and efficacy of PF-03715455 in moderate to severe asthma when added to standard of care and during staged withdrawal of background therapy.
详细描述
Study terminated on 7th April 2015. The termination was due to business reasons. No safety or efficacy concerns contributed to the termination of the study
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a physician documented history or diagnosis of persistent asthma (according to GINA, 2014 definition of asthma),
- •Pre bronchodilator FEV1 of greater than or equal to 50 and less that 80% of predicted.
- •Subjects defined as GINA Step 4 on a stable dose of either fluticasone/salmeterol combination therapy, or budesonide/formoterol combination therapy or mometasone/formoterol combination therapy.
- •Subjects who are defined as uncontrolled as evidenced by; Juniper Asthma Control Questionnaire (5 item version, ACQ) score greater than or equal to 1.5 and less than or equal to 3.0)
排除标准
- •Subjects diagnosed with chronic pulmonary disease (COPD) and/or other chronic pulmonary diseases (eg, Occupational asthma, pulmonary fibrosis, bronchiectasis, Allergic bronchopulmonary aspergillosis (ABPA), pneumoconiosis, sarcoidosis, tuberculosis).
- •Subjects who are current smokers.
研究组 & 干预措施
Placebo
Matched blinded placebo
干预措施: Placebo (Drug)
PF-03715455
PF-03715455
干预措施: PF-03715455 (Drug)
结局指标
主要结局
Percentage of Participants With Asthma Worsening Events
时间窗: Baseline up to follow-up period (Week 16)
Asthma worsening was defined as one of the following events: greater than or equal to (\>=) 30% reduction from baseline in morning peak expiratory flow (PEF) on 2 consecutive days; \>=6 additional rescue puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; deterioration of asthma (as determined by the Investigator) requiring systemic steroid treatment, an increase in inhaled corticosteroids \>=4 times the last dose received prior to discontinuation from the study, or hospitalization due to asthma.
次要结局
- Time to Asthma Worsening Event(Baseline up to follow-up period (Week 16))
- Change From Baseline in Forced Expiratory Volume in 6 Seconds (FEV6)(Baseline, Week 1, Week 2, Week 3, and Week 4)
- Change From Baseline in Asthma Symptom Scores(Baseline, Week 1, Week 2, Week 3, and Week 4)
- Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score at Week 1, Week 2, Week 3, and Week 4(Baseline, Week 1, Week 2, Week 3, and Week 4)
- Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)(Baseline, Week 1, Week 2, Week 3, and Week 4)
- Change From Baseline in Forced Vital Capacity (FVC)(Baseline, Week 1, Week 2, Week 3, and Week 4)
- Number of Night Time Awakenings Per Week(Baseline, Week 1, Week 2, Week 3, and Week 4)
- Number of Daily Puffs of Rescue Medication(Baseline, Week 1, Week 2, Week 3, and Week 4)
- Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF)(Baseline, Week 1, Week 2, Week 3, and Week 4)