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

Sponsor
Mylan Pharma UK Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05046795
Collaborator
(none)
320
Enrollment
35
Locations
2
Arms
11.6
Anticipated Duration (Months)
9.1
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Revefenacin 175 mcg in 3 ML Inhalation Solution
  • Drug: Placebo inhalation solution QD
 Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
320 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Multicenter, randomized, double-blind, placebo-control, parallel group studyMulticenter, randomized, double-blind, placebo-control, parallel group study
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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).
Actual Study Start Date :
Nov 10, 2021
Anticipated Primary Completion Date :
Oct 30, 2022
Anticipated Study Completion Date :
Oct 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Revefenacin inhalation solution 175 mcg QD.

Revefenacin inhalation solution 175 mcg QD.

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

Placebo inhalation solution QD.

Drug: Placebo inhalation solution QD
Placebo

Outcome Measures

Primary Outcome Measures

  1. Trough FEV1 on Day 85 [up to 12 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anhui Medical University - Hefei First People's Hospital Hefei Anhui China 230061
2 Peking University Third Hospital Beijing Beijing China 100191
3 Beijing Hospital Beijing Beijing China 100730
4 The Third Affiliated Hospital Of Guangzhou Medical University Guangzhou Guangdong China 510150
5 Guangzhou First People's Hospital Guangzhou Guangdong China 510180
6 The Second Affiliated Hospital Of Guangzhou Medical University Guangzhou Guangdong China 510260
7 Affiliated Hospital of Guangdong Medical University Guangzhou Guangdong China 524000
8 The First Affiliated Hospital of Guangzhou Medical University Guangzhou Gunagdong China 510120
9 Hainan General Hospital Haikou Hainan China 570311
10 The First Hospital of Changsha Changsha Hunan China 410005
11 Inner Mongolia Baogang Hospital Baotou Inner Mongolia China 014010
12 The First Affiliated Hospital of Baotou Medical College - Respiration Baotou Inner Mongolia China 014017
13 Inner Mongolia People's Hospital Hohhot Inner Mongolia China 10017
14 Affiliated Hospital of Inner Mongolia Medical College Hohhot Inner Mongolia China 10050
15 Jiangsu Jiangyin People's Hospital Jiangyin Jiangsu China 214400
16 Zhongda Hospital, Southeast University - Pulmonology Nanjing Jiangsu China 210009
17 Nanjing Jiangning Hospital Nanjing Jiangsu China 211100
18 Wuxi People's Hospital Wuxi Jiangsu China 214023
19 Yangzhou First People's Hospital Yangzhou Jiangsu China 225001
20 Jiangxi Provincial People's Hospital Nanchang Jiangxi China 330006
21 Nanchang University - The Second Affiliated Hospital Nanchang Jiangxi China 330006
22 Jiangxi Pingxiang People's Hospital Pingxiang Jiangxi China 337000
23 The First Bethune Hospital of Jilin University Changchun Jilin China 130021
24 Yanbian university hospital Yanji Jilin China 133000
25 The First Hospital of China Medical University Shenyang Liaoning China 110001
26 Shengjing Hospital of China Medical University Shenyang Liaoning China 110004
27 Shanghai East Hospital Shanghai Shanghai China 200031
28 Shanghai Pudong New Area People's Hospital Shanghai Shanghai China 201299
29 Sichuan University - West China Hospital Chengdu Sichuan China 332001
30 Tianjin Medical University General Hospital - Respiration Tianjin Tianjin China 300052
31 The First Center hospital of Tianjin Tianjin Tianjin China 300192
32 The First Affiliated Hospital of Xinjiang Medical University - Hospital Urumqi Xinjiang China 830054
33 Dongyang People's Hospital Dongyang Zhejiang China 322199
34 Xinhua Hostipal of Zhejiang Province Hangzhou Zhejiang China 310005
35 Huzhou Central Hospital Huzhou Zhejiang China 313003

Sponsors and Collaborators

  • Mylan Pharma UK Ltd.

Investigators

  • Study Director: Dik WH Ng, PhD, Mylan Pharmaceuticals Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mylan Pharma UK Ltd.
ClinicalTrials.gov Identifier:
NCT05046795
Other Study ID Numbers:
  • REV-3001
First Posted:
Sep 16, 2021
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mylan Pharma UK Ltd.
Revefenacin
Long-acting muscarinic receptor antagonist(LAMA)
Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pharmaceutical Solutions

Study Results

No Results Posted as of Aug 24, 2022