A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study of Nebulized Revefenacin Inhalation Solution in Chinese Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 258
- 试验地点
- 35
- 主要终点
- Trough FEV1 on Day 85
研究概览
简要总结
This study is a phase III clinical study to assess the efficacy and safety of Revefenacin inhalation solution 175 mcg administered once daily via nebulization for 12 weeks compared to placebo in a population of Chinese subjects with moderate to very severe COPD.
详细描述
This will be a multi-center, randomized, double blind, placebo-controlled, parallel group study, randomizing approximately 320 male or female moderate-very severe COPD subjects. Subjects will receive study drug for 12 weeks. Treatments to be received during the study will include one of the following, administered using a centrally-provided, standard jet nebulizer and compressor via a mouthpiece: A. Revefenacin inhalation solution 175 mcg Quaque die (QD). B. Placebo inhalation solution QD. Subjects will have approximately 6 clinic visits (encompassing a screening period of up to 30 days and a treatment period of 12 weeks), and a follow-up telephone call 1-2 weeks after the End of Treatment (EoT) visit.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Key inclusion criteria include:
- •Males and females of Chinese ethnicity, at least 40 years of age. Females may be of either childbearing or non-childbearing potential. All females of childbearing potential must be using an acceptable, highly effective method of contraception and have a negative pregnancy test at screening.
- •A clinical diagnosis for at least 6 months prior to screening of COPD according to Global Initiative for Chronic Obstructive Lung Disease(GOLD) guidelines.
- •Subject is capable of performing reproducible spirometry maneuvers as described by current American Thoracic Society/European Respiratory Society (ATS/ERS) Guidelines and has a post-ipratropium (500 mcg nebulized) Forced Expiratory Volume in
- •1 second(FEV1)/Forced Vital Capacity(FVC) ratio <0.7 at Visit
- •Subject has moderate to very severe COPD with a post-ipratropium (500 mcg nebulized) FEV1 less than 80% of predicted normal (using the Global Lung Function Initiative reference range; ) and an absolute FEV1 >700 mL at Visit 2
- •Current smoker or ex-smoker, with a history of at least 10 pack-years of tobacco smoking. Ex-smokers must have stopped smoking >6 months prior to Visit 1.
排除标准
- •Key exclusion criteria include:
- •Previously dosed with Revefenacin.
- •Current diagnosis of asthma.
- •Alpha-1 anti-trypsin deficiency.
- •Other chronic or active respiratory disorder (e.g., clinically significant [as determined by the Investigator] bronchiectasis, pulmonary fibrosis, sarcoidosis, pneumoconiosis, active tuberculosis).
- •Symptoms of, or treatment for an Acute Exacerbation of COPD(AECOPD) requiring antibiotics and/or oral/systemic corticosteroids or in-patient hospitalization during the 28 days preceding screening or during the screening period between Visit 1 and Visit
- •Pneumonia requiring hospitalization within 28 days prior to screening or during the screening period between Visit 1 and Visit
- •Lower respiratory tract infection requiring treatment with antibiotics during the 28 days preceding screening or during the screening period between Visit 1 and Visit
- •History or presence of pulmonary hypertension, respiratory failure, cor pulmonale or right ventricular failure which may impact the safety of the subject in the clinical judgement of the Investigator.
- •History of pulmonary lobectomy, lung volume reduction surgery, or lung transplantation.
- •Use of supplemental oxygen therapy for more than 15 hours per day (includes night-time use).
- •Subjects with hepatic impairment.
- •Subject suffers from any medical condition that would preclude the use of inhaled anticholinergics, including narrow-angle glaucoma, symptomatic benign prostatic hyperplasia, bladder neck obstruction, or urinary retention.
- •Subjects who are unable to stop any of the following medications, and refrain from their use throughout the study until the final dose of study drug:
- •Short-acting β2 agonists (except study-supplied salbutamol).
- •Short-acting anticholinergic agents (except those used for reversibility testing).
- •Long-acting anticholinergics (except study supplied medication).
- •Combination β2 agonists/anticholinergic agents.
- •Combination β2 agonists/inhaled corticosteroids/anticholinergic agents.
- •Phosphodiesterase 4 inhibitors.
- •Theophyllines.
- •Leukotriene inhibitors.
- •Orally inhaled nedocromil or cromolyn sodium.
- •Oral or parenteral corticosteroids.
研究组 & 干预措施
Revefenacin inhalation solution 175 mcg QD.
Revefenacin inhalation solution 175 mcg QD.
干预措施: Revefenacin 175 mcg in 3 ML Inhalation Solution (Drug)
Placebo inhalation solution QD.
Placebo inhalation solution QD.
干预措施: Placebo inhalation solution QD (Drug)
结局指标
主要结局
Trough FEV1 on Day 85
时间窗: Baseline and Day 85
Change from Baseline (Day 1, pre-dose) trough FEV1 on Day 85
Trough FEV1 on Day 85 - Sensitivity Analysis With Missing Data Imputed
时间窗: Baseline, Day 29, Day 57 and Day 85
Sensitivity analysis results of change from baseline in trough FEV1 (mL) on Day 85 with missing data imputed by last observation carried forward
次要结局
- Trough FVC on Day 85(Baseline and Day 85)
- Change From Baseline in Peak FEV1 (0-2h) on Day 1(Day 1, from 45 minutes before dosing to 2 hours after dosing)
- Change From Baseline in Peak FEV1 (0-2h) on Day 85(Day 1 (baseline) and Day 85, from 45 minutes before dosing to 2 hours after dosing)
- Change From Baseline in SGRQ Total Score on Day 85(Day 1 (baseline) and Day 85)
- Number (%) of SGRQ Responders on Day 85(Day 85)