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COPDPhase 3NCT05046795

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

A Phase 3 study testing Revefenacin 175 mcg in 3 ML Inhalation Solution in people with COPD, run by Mylan Pharma UK Ltd. at 35 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
COPD
What is being tested?
Revefenacin 175 mcg in 3 ML Inhalation Solution
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
258 participants
Where
35 sitesChina
Study dates
10 Nov 2021to 26 Jul 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 23Show fewer
  • 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.

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

China35 sites

  • Inner Mongolia Baogang Hospital

    Baotou, Inner Mongolia, 014010

  • The First Affiliated Hospital of Baotou Medical College - Respiration

    Baotou, Inner Mongolia, 014017

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin, 130021

  • The First Hospital of Changsha

    Changsha, Hunan, 410005

  • Sichuan University - West China Hospital

    Chengdu, Sichuan, 332001

  • Dongyang People's Hospital

    Dongyang, Zhejiang, 322199

  • The Third Affiliated Hospital Of Guangzhou Medical University

    Guangzhou, Guangdong, 510150

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510180

  • The Second Affiliated Hospital Of Guangzhou Medical University

    Guangzhou, Guangdong, 510260

  • Affiliated Hospital of Guangdong Medical University

    Guangzhou, Guangdong, 524000

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Gunagdong, 510120

  • Hainan General Hospital

    Haikou, Hainan, 570311

  • Xinhua Hostipal of Zhejiang Province

    Hangzhou, Zhejiang, 310005

  • Anhui Medical University - Hefei First People's Hospital

    Hefei, Anhui, 230061

  • Inner Mongolia People's Hospital

    Hohhot, Inner Mongolia, 10017

  • Affiliated Hospital of Inner Mongolia Medical College

    Hohhot, Inner Mongolia, 10050

  • Huzhou Central Hospital

    Huzhou, Zhejiang, 313003

  • Jiangsu Jiangyin People's Hospital

    Jiangyin, Jiangsu, 214400

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330006

  • Nanchang University - The Second Affiliated Hospital

    Nanchang, Jiangxi, 330006

  • Zhongda Hospital, Southeast University - Pulmonology

    Nanjing, Jiangsu, 210009

  • Nanjing Jiangning Hospital

    Nanjing, Jiangsu, 211100

  • Jiangxi Pingxiang People's Hospital

    Pingxiang, Jiangxi, 337000

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200031

  • Shanghai Pudong New Area People's Hospital

    Shanghai, Shanghai Municipality, 201299

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

  • Tianjin Medical University General Hospital - Respiration

    Tianjin, Tianjin Municipality, 300052

  • The First Center hospital of Tianjin

    Tianjin, Tianjin Municipality, 300192

  • The First Affiliated Hospital of Xinjiang Medical University - Hospital

    Ürümqi, Xinjiang, 830054

  • Wuxi People's Hospital

    Wuxi, Jiangsu, 214023

  • Yangzhou First People's Hospital

    Yangzhou, Jiangsu, 225001

  • Yanbian university hospital

    Yanji, Jilin, 133000

Other trials in China

About this study

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).

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.

Read the 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
Being tested
Revefenacin 175 mcg in 3 ML Inhalation Solution, Placebo inhalation solution QD
Keywords
Revefenacin, Long-acting muscarinic receptor antagonist(LAMA)
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Revefenacin 175 mcg in 3 ML Inhalation SolutionDrug

    Revefenacin

  • Placebo inhalation solution QDDrug

    Placebo

Study groups in NCT05046795
Study groupRoleWhat they receive
Revefenacin inhalation solution 175 mcg QD.ExperimentalRevefenacin inhalation solution 175 mcg QD.
Receives: Drug: Revefenacin 175 mcg in 3 ML Inhalation Solution
Placebo inhalation solution QD.Placebo comparatorPlacebo inhalation solution QD.
Receives: Drug: Placebo inhalation solution QD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Trough FEV1 on Day 85

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

    Measured: Baseline and Day 85

  2. 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

    Measured: Baseline, Day 29, Day 57 and Day 85

Secondary outcomes (5)

  1. Trough FVC on Day 85

    Change from baseline (Day 1, pre-dose) trough Forced Vital Capacity (FVC) on Day 85

    Measured: Baseline and Day 85

  2. Change From Baseline in Peak FEV1 (0-2h) on Day 1

    Baseline FEV1 was defined as the average of the -45 and -15 minute measurements prior to dosing of study drug on Day 1. Peak FEV1 (0-2h) was defined as the highest post dose FEV1 value within 2 hours after the dosing.

    Measured: Day 1, from 45 minutes before dosing to 2 hours after dosing

  3. Change From Baseline in Peak FEV1 (0-2h) on Day 85

    Baseline FEV1 was defined as the average of the -45 and -15 minute measurements prior to dosing of study drug on Day 1. Peak FEV1 (0-2h) was defined as the highest post dose FEV1 value within 2 hours after the dosing.

    Measured: Day 1 (baseline) and Day 85, from 45 minutes before dosing to 2 hours after dosing

  4. Change From Baseline in SGRQ Total Score on Day 85

    Change from Baseline in the St George's Respiratory Questionnaire (SGRQ) Total Score on Day 85.

    Scores range from 0 to 100, with higher scores indicating more health limitations. A reduction of 4 or more points is considered to be a clinically meaningful improvement

    Measured: Day 1 (baseline) and Day 85

  5. Number (%) of SGRQ Responders on Day 85

    Number of subjects with a decrease from baseline of ≥4 units in SGRQ total score (which was defined as a responder) on Day 85

    Measured: Day 85

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2021
  2. Study start10 Nov 2021
  3. Primary completion26 Jul 2023
  4. Study completion26 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicenter, randomized, double-blind, placebo-control, parallel group study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
258 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05046795
Sponsor's protocol ID
REV-3001
Status last verified
Oct 2024
First submitted
7 Sep 2021
Last updated
1 Nov 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Revefenacin 175 mcg in 3 ML Inhalation Solution in people with COPD, run by Mylan Pharma UK Ltd. at 35 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Trough FEV1 on Day 85 (time frame: Baseline and Day 85). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05046795.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.

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