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

NCT05046795 | Completed Phase 3 Results

• 1 other identifier: REV-3001
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 35

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.

Conditions

COPD

Keywords

Revefenacin; Long-acting muscarinic receptor antagonist(LAMA)

Outcome Measures

Primary Outcomes (2)

• Trough FEV1 on Day 85

  Change from Baseline (Day 1, pre-dose) trough FEV1 on Day 85

  Baseline and Day 85

• Trough FEV1 on Day 85 - Sensitivity Analysis With Missing Data Imputed

  Sensitivity analysis results of change from baseline in trough FEV1 (mL) on Day 85 with missing data imputed by last observation carried forward

  Baseline, Day 29, Day 57 and Day 85

Secondary Outcomes (5)

• 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

Study Arms (2)

Revefenacin inhalation solution 175 mcg QD.

EXPERIMENTAL

Revefenacin inhalation solution 175 mcg QD.

Drug: Revefenacin 175 mcg in 3 ML Inhalation Solution

Placebo inhalation solution QD.

PLACEBO COMPARATOR

Placebo inhalation solution QD.

Drug: Placebo inhalation solution QD

Interventions

Revefenacin 175 mcg in 3 ML Inhalation Solution DRUG

Revefenacin

Revefenacin inhalation solution 175 mcg QD.

Placebo inhalation solution QD DRUG

Placebo

Placebo inhalation solution QD.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mylan Pharma UK Ltd.: lead

Study Sites (35)

Anhui Medical University - Hefei First People's Hospital

Hefei, Anhui, 230061, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

Location

The Third Affiliated Hospital Of Guangzhou Medical University

Guangzhou, Guangdong, 510150, China

Location

Guangzhou First People's Hospital

Guangzhou, Guangdong, 510180, China

Location

The Second Affiliated Hospital Of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location

Affiliated Hospital of Guangdong Medical University

Guangzhou, Guangdong, 524000, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Gunagdong, 510120, China

Location

Hainan General Hospital

Haikou, Hainan, 570311, China

Location

The First Hospital of Changsha

Changsha, Hunan, 410005, China

Location

Inner Mongolia Baogang Hospital

Baotou, Inner Mongolia, 014010, China

Location

The First Affiliated Hospital of Baotou Medical College - Respiration

Baotou, Inner Mongolia, 014017, China

Location

Inner Mongolia People's Hospital

Hohhot, Inner Mongolia, 10017, China

Location

Affiliated Hospital of Inner Mongolia Medical College

Hohhot, Inner Mongolia, 10050, China

Location

Jiangsu Jiangyin People's Hospital

Jiangyin, Jiangsu, 214400, China

Location

Zhongda Hospital, Southeast University - Pulmonology

Nanjing, Jiangsu, 210009, China

Location

Nanjing Jiangning Hospital

Nanjing, Jiangsu, 211100, China

Location

Wuxi People's Hospital

Wuxi, Jiangsu, 214023, China

Location

Yangzhou First People's Hospital

Yangzhou, Jiangsu, 225001, China

Location

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, 330006, China

Location

Nanchang University - The Second Affiliated Hospital

Nanchang, Jiangxi, 330006, China

Location

Jiangxi Pingxiang People's Hospital

Pingxiang, Jiangxi, 337000, China

Location

The First Bethune Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Yanbian university hospital

Yanji, Jilin, 133000, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Location

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200031, China

Location

Shanghai Pudong New Area People's Hospital

Shanghai, Shanghai Municipality, 201299, China

Location

Sichuan University - West China Hospital

Chengdu, Sichuan, 332001, China

Location

Tianjin Medical University General Hospital - Respiration

Tianjin, Tianjin Municipality, 300052, China

Location

The First Center hospital of Tianjin

Tianjin, Tianjin Municipality, 300192, China

Location

The First Affiliated Hospital of Xinjiang Medical University - Hospital

Ürümqi, Xinjiang, 830054, China

Location

Dongyang People's Hospital

Dongyang, Zhejiang, 322199, China

Location

Xinhua Hostipal of Zhejiang Province

Hangzhou, Zhejiang, 310005, China

Location

Huzhou Central Hospital

Huzhou, Zhejiang, 313003, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

revefenacin

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dik WH Ng, PhD
• Organization: Viatris

dik.ng@viatris.com

+44 (0)1304 626895

Study Officials

• Dik WH Ng, PhD

  Mylan Pharmaceuticals Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, randomized, double-blind, placebo-control, parallel group study

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 16, 2021
• Study Start: November 10, 2021
• Primary Completion: July 26, 2023
• Study Completion: July 26, 2023
• Last Updated: November 1, 2024
• Results First Posted: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (35)