Revefenacin in Chinese Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease(COPD)

NCT ID: NCT05046795

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 258 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-10
• Study Completion Date: 2023-07-26

Brief Summary

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.

Detailed Description

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.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Revefenacin inhalation solution 175 mcg QD.

Revefenacin inhalation solution 175 mcg QD.

Group Type: EXPERIMENTAL

Revefenacin 175 mcg in 3 ML Inhalation Solution

Intervention Type: DRUG

Revefenacin

Placebo inhalation solution QD.

Placebo inhalation solution QD.

Group Type: PLACEBO_COMPARATOR

Placebo inhalation solution QD

Intervention Type: DRUG

Placebo

Interventions

Revefenacin 175 mcg in 3 ML Inhalation Solution

Revefenacin

Intervention Type: DRUG

Placebo inhalation solution QD

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mylan Pharma UK Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dik WH Ng, PhD

Role: STUDY_DIRECTOR

Mylan Pharmaceuticals Inc

Locations

Anhui Medical University - Hefei First People's Hospital

Hefei, Anhui, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

Beijing Hospital

Beijing, Beijing Municipality, China

The Third Affiliated Hospital Of Guangzhou Medical University

Guangzhou, Guangdong, China

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

The Second Affiliated Hospital Of Guangzhou Medical University

Guangzhou, Guangdong, China

Affiliated Hospital of Guangdong Medical University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Gunagdong, China

Hainan General Hospital

Haikou, Hainan, China

The First Hospital of Changsha

Changsha, Hunan, China

Inner Mongolia Baogang Hospital

Baotou, Inner Mongolia, China

The First Affiliated Hospital of Baotou Medical College - Respiration

Baotou, Inner Mongolia, China

Inner Mongolia People's Hospital

Hohhot, Inner Mongolia, China

Affiliated Hospital of Inner Mongolia Medical College

Hohhot, Inner Mongolia, China

Jiangsu Jiangyin People's Hospital

Jiangyin, Jiangsu, China

Zhongda Hospital, Southeast University - Pulmonology

Nanjing, Jiangsu, China

Nanjing Jiangning Hospital

Nanjing, Jiangsu, China

Wuxi People's Hospital

Wuxi, Jiangsu, China

Yangzhou First People's Hospital

Yangzhou, Jiangsu, China

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

Nanchang University - The Second Affiliated Hospital

Nanchang, Jiangxi, China

Jiangxi Pingxiang People's Hospital

Pingxiang, Jiangxi, China

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

Yanbian university hospital

Yanji, Jilin, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Shanghai Pudong New Area People's Hospital

Shanghai, Shanghai Municipality, China

Sichuan University - West China Hospital

Chengdu, Sichuan, China

Tianjin Medical University General Hospital - Respiration

Tianjin, Tianjin Municipality, China

The First Center hospital of Tianjin

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital of Xinjiang Medical University - Hospital

Ürümqi, Xinjiang, China

Dongyang People's Hospital

Dongyang, Zhejiang, China

Xinhua Hostipal of Zhejiang Province

Hangzhou, Zhejiang, China

Huzhou Central Hospital

Huzhou, Zhejiang, China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

REV-3001

Identifier Type: -

Identifier Source: org_study_id