Health Condition 1: J44- Other chronic obstructive pulmonary disease
Conditions
Interventions
Intervention1: Revefenacin: Revefenacin 175 mcg, Frequency- once daily, route of administration – Inhalation, total duration of such intervention- approximately 12 weeks
Control Intervention1: Placebo
Sponsors
Mylan Pharmaceuticals Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female subjects, at least 40 years of age (i.e., =40 years). 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. 2. A clinical diagnosis for at least 6 months prior to screening of COPD according to GOLD guidelines 3. 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. 4. Capable of self-administering (or with the help of a caregiver) study medication, 5. Able to understand and complete the study requirements, provide written informed consent, and agree to abide by the study protocol and its restrictions.
Exclusion criteria
Exclusion criteria: 1. Previously dosed with revefenacin. 2. Current diagnosis of asthma. 3. Alpha-1 anti-trypsin deficiency. 4. Other chronic or active respiratory disorder 5. Symptoms of, or treatment for an AE COPD requiring antibiotics and/or oral/systemic corticosteroids or in-patient hospitalization. 6. History or presence of pulmonary hypertension, respiratory failure, cor pulmonale or right ventricular failure, surgical treatments to the lungs. 7. Use of supplemental oxygen therapy for more than 15 hours per day 8. Subjects participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the trial (maintenance program is permitted). 9. Clinically significant, abnormal chest X-ray at screening indicating an active/significant disease process other than COPD.. 10. 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. 11. Use of medications with the potential to interact with revefenacin, salbutamol or ipratropium bromide or medications with the potential to affect or confound COPD disease status. 12. History of reactions/hypersensitivity to any of the following inhaled drugs or drugs of a similar class: short- or long- acting ß2 agonists, anticholinergic agents, corticosteroids, sympathomimetic amines.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary estimand is, the difference (Revefenacin – Placebo) in the Change From Baseline (CFB) in Trough Forced Expiratory Volume in 1 second (FEV1) on Day 85Timepoint: Approximately 12 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| • CFB to Peak FEV1 (during the 2 hours post-dose) on Day 1. • CFB in Trough FVC on Day 85. • CFB in Trough FEV1 on Day 29. • CFB in Trough FVC on Day 29. • CFB to Peak FVC on Day 1. • St. George’s Respiratory Questionnaire (SGRQ) responders on Day 85. Timepoint: Approximately 12 Weeks | — |
Countries
India
Contacts
Public ContactMr Devesh Verma
Cliantha Research Limited
Outcome results
None listed