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

• Status: Not yet recruiting
• Trial end date: 2022-10-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mylan Inc.
• Collaborator: Mylan Pharmaceuticals
• Treatments: Pharmaceutical Solutions

Criteria

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.