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

COPD Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05046795
• Other study ID #: REV-3001
• Status: Completed
• Phase: Phase 3
• Start date: November 10, 2021
• Est. completion date: July 26, 2023

Study information

• Verified date: August 2023
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: July 26, 2023
• Est. primary completion date: July 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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 ß2 agonists (except study-supplied salbutamol).

• Short-acting anticholinergic agents (except those used for reversibility testing).

• Long-acting anticholinergics (except study supplied medication).

• Combination ß2 agonists/anticholinergic agents.

• Combination ß2 agonists/inhaled corticosteroids/anticholinergic agents.

• Phosphodiesterase 4 inhibitors.

• Theophyllines.

• Leukotriene inhibitors.

• Orally inhaled nedocromil or cromolyn sodium.

• Oral or parenteral corticosteroids.

Related Conditions & MeSH terms

• COPD
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Revefenacin 175 mcg in 3 ML Inhalation Solution
Revefenacin
• Placebo inhalation solution QD
Placebo

Locations

Country	Name	City	State
China	Inner Mongolia Baogang Hospital	Baotou	Inner Mongolia
China	The First Affiliated Hospital of Baotou Medical College - Respiration	Baotou	Inner Mongolia
China	Beijing Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	The First Bethune Hospital of Jilin University	Changchun	Jilin
China	The First Hospital of Changsha	Changsha	Hunan
China	Sichuan University - West China Hospital	Chengdu	Sichuan
China	Dongyang People's Hospital	Dongyang	Zhejiang
China	Affiliated Hospital of Guangdong Medical University	Guangzhou	Guangdong
China	Guangzhou First People's Hospital	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Gunagdong
China	The Second Affiliated Hospital Of Guangzhou Medical University	Guangzhou	Guangdong
China	The Third Affiliated Hospital Of Guangzhou Medical University	Guangzhou	Guangdong
China	Hainan General Hospital	Haikou	Hainan
China	Xinhua Hostipal of Zhejiang Province	Hangzhou	Zhejiang
China	Anhui Medical University - Hefei First People's Hospital	Hefei	Anhui
China	Affiliated Hospital of Inner Mongolia Medical College	Hohhot	Inner Mongolia
China	Inner Mongolia People's Hospital	Hohhot	Inner Mongolia
China	Huzhou Central Hospital	Huzhou	Zhejiang
China	Jiangsu Jiangyin People's Hospital	Jiangyin	Jiangsu
China	Jiangxi Provincial People's Hospital	Nanchang	Jiangxi
China	Nanchang University - The Second Affiliated Hospital	Nanchang	Jiangxi
China	Nanjing Jiangning Hospital	Nanjing	Jiangsu
China	Zhongda Hospital, Southeast University - Pulmonology	Nanjing	Jiangsu
China	Jiangxi Pingxiang People's Hospital	Pingxiang	Jiangxi
China	Shanghai East Hospital	Shanghai	Shanghai
China	Shanghai Pudong New Area People's Hospital	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	The First Center hospital of Tianjin	Tianjin	Tianjin
China	Tianjin Medical University General Hospital - Respiration	Tianjin	Tianjin
China	The First Affiliated Hospital of Xinjiang Medical University - Hospital	Urumqi	Xinjiang
China	Wuxi People's Hospital	Wuxi	Jiangsu
China	Yangzhou First People's Hospital	Yangzhou	Jiangsu
China	Yanbian university hospital	Yanji	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Mylan Pharma UK Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trough FEV1 on Day 85	Change from Baseline (Day 1, pre-dose) trough FEV1 on Day 85	up to 12 weeks