NCT00430300终止2 期
A Phase II, Randomized, Double Blind, Placebo Controlled, Parallel Group Study To Evaluate the Efficacy And Safety of UK-432,097 Dry Powder For Inhalation In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6
研究概览
简要总结
Safety and efficacy (measured by spirometry) of UK-432,097 administration will be tested in patients with chronic obstructive pulmonary disease.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease
- •Patients must have a smoking history of at least 10 pack-years
- •Patients must have stable disease for at least 1 month prior to screening.
排除标准
- •More than 2 exacerbations of COPD in the preceding year
- •History of a lower respiratory tract infection or significant disease instability during the month proceding screening or during the time between screen and randomization.
- •History or presence of respiratory failure, cor pulmonale or right ventricular failure
研究组 & 干预措施
150mcg, 450mcg or 1350mcg
Experimental
Active treatment given BID via a double pin monodose capsule inhaler device
干预措施: UK-432,097 (Drug)
Placebo
Placebo Comparator
Placebo treatment given BID via a single pin monodose inhaler device
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6
时间窗: Pre-dose at Baseline, Week 6
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.
次要结局
- Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8(Pre-dose at Baseline, Week 2, 4, 8)
- Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8(Pre-dose at Baseline, Week 2, 4, 6, 8)
- Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8(Pre-dose at Baseline, Week 2, 4, 6, 8)
- Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8(Pre-dose at Baseline, Week 2, 4, 6, 8)
- Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6(15 to 30 minutes post-dose at Baseline, Week 2, 4, 6)
- Change From Baseline in Post-Study Drug FEV6 at Week 2, 4, and 6(15 to 30 minutes post-dose at Baseline, Week 2, 4, 6)
- Change From Baseline in Post-Study Drug FVC at Week 2, 4, and 6(15 to 30 minutes post-dose at Baseline, Week 2, 4, 6)
- Change From Baseline in Post-Study Drug IC at Week 2, 4, and 6(15 to 30 minutes post-dose at Baseline, Week 2, 4, 6)
- Change From Baseline in Post-Bronchodilator IC at Week 6(15 to 30 minutes post-bronchodilator administration at Baseline, Week 6)
- Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6(Baseline, Week 2, 4, 6)
- Change From Baseline in Post-Bronchodilator FEV1 at Week 6(15 to 30 minutes post-bronchodilator administration at Baseline, Week 6)
- Change From Baseline in Post-Bronchodilator FEV6 at Week 6(15 to 30 minutes post-bronchodilator administration at Baseline, Week 6)
- Change From Baseline in Post-Bronchodilator FVC at Week 6(15 to 30 minutes post-bronchodilator administration at Baseline, Week 6)
- Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8(Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8)
- Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8(Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8)
- Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8(Pre-dose at Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8)
- Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C)(Week 6)
- Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)(Week 6)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Phase 2 Study of the Safety and Efficacy of UK-500,001 in Adult Patients With COPDPulmonary Disease, Chronic ObstructiveNCT00263874Pfizer324
已完成
2 期
The Efficacy and Safety of Pirfenidone in Patients With Heart Failure and Preserved Left Ventricular Ejection FractionCardiac FailureNCT02932566Manchester University NHS Foundation Trust129
已完成
2 期
Safety and Efficacy of C21 in Subjects With COVID-19COVID-19NCT04452435Vicore Pharma AB206
终止
2 期
Study to Evaluate PF-04965842 in Patients With Moderate to Severe PsoriasisPlaque PsoriasisNCT02201524Pfizer59
已完成
2 期
Efficacy, Safety, and Tolerability, of EN3835 vs Placebo in the Treatment of Plantar FibromatosisPlantar FibromatosisNCT05152173Endo Pharmaceuticals177