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).

REV-3001

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.

2021-11-10

2023-07-26

2023-07-26

Completed

Early phase I

258

Inclusion Criteria: * 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 2. * 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. Exclusion Criteria: * 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 3. * Pneumonia requiring hospitalization within 28 days prior to screening or during the screening period between Visit 1 and Visit 3. * Lower respiratory tract infection requiring treatment with antibiotics during the 28 days preceding screening or during the screening period between Visit 1 and Visit 3. * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicenter, randomized, double-blind, placebo-control, parallel group study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 258, 'type': 'ACTUAL'}}

2023-08-18