CTRI/2022/09/045402
Completed
Phase 3
A Double-Blind, placebo-controlled study of nebulized revefenacin inhalation solution in Indian Subjects with moderate to very severe chronic obstructive pulmonary disease (COPD).
Mylan Pharmaceuticals Pvt Ltd0 sites244 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: J44- Other chronic obstructive pulmonary disease
- Sponsor
- Mylan Pharmaceuticals Pvt Ltd
- Enrollment
- 244
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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