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

Mylan

Status and phase: Completed; Phase 3

Conditions: COPD

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05046795

REV-3001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 258 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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258 participants in 2 patient groups, including a placebo group

Revefenacin inhalation solution 175 mcg QD.

Experimental group

Description:

Revefenacin inhalation solution 175 mcg QD.

Treatment:

Drug: Revefenacin 175 mcg in 3 ML Inhalation Solution

Placebo inhalation solution QD.

Placebo Comparator group

Description:

Placebo inhalation solution QD.

Treatment:

Drug: Placebo inhalation solution QD