Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Intervention1: Revefenacin inhalation solution: 175 mcg (3 mL vial) for oral inhalation. For use with a standard jet nebulizer. Once Daily For 12 weeks.
Control Intervention1: Tiotropium dry powder fo
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged 40 years and above with documented diagnosis of COPD based on Global Initiative for Chronic Obstructive LungDisease guideline 2025 2. Subject has a current or past cigarette smoking history or exposure to noxious stimuli 3. Subjects has a post-ipratropium FEV1/FVC ratio of less than 0.7 and post-ipratropium FEV1 of less than 80% to Greater than and equal to 30% ofpredicted normal and an absolute FEV1 of at least 700 ml at screening. 4. Subjects with CAT score greater than 10.
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to similar class of drugs or to any of the excipients of the formulations. 2. Subjects who have previously taken revefenacin. 3. Subjects with history of myocardial infarction or unstable angina within the previous 6 months, unstable or life-threatening cardiac arrhythmia requiringintervention within the previous 3 months. 4. Subject with NYHA Class IV heart failure prior to the start of the study or exhibited an abnormal and clinically significant 12-lead ECG (QTcF greaterthan 500msec) at screening. 5. Subjects with unstable cardiovascular disease including history of one or more of pre-specified cardiac disorders such as ischemic heart disease,cerebrovascular disease, peripheral arterial disease, heart failure and/or hypertension. 6. Any medical condition precluding use of inhaled anticholinergics, including paradoxical bronchospasm, narrow-angle glaucoma, or symptomatic prostatichypertrophy or bladder outlet obstruction, urinary retention. 7. Subjects with concomitant clinically significant respiratory disease, other than COPD as determined by the Investigator such as asthma, bronchiectasis,pulmonary fibrosis, sarcoidosis, pneumoconiosis, active tuberculosis, or a recent history of respiratory tract infection within 6 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference of mean change in trough Forced Expiratory Volume in 1 second (FEV1) between the two treatment groups.Timepoint: Difference of mean change in trough Forced Expiratory Volume in 1 second (FEV1) between the two treatment groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference of mean change in trough FEV1 between the two treatment groups.Timepoint: At week 4 and week 8 from baseline;Difference of mean change in trough FVC between the two treatment groups.Timepoint: At week 4, week 8 and week 12 from baseline;Difference of mean change in COPD Assessment Test (CAT) score between the two treatment groupsTimepoint: At week 4, week 8 and week 12 from baseline;Difference of mean change in St. George s Respiratory Questionnaire (SGRQ) score between the two treatment groupsTimepoint: At week 4, week 8 and week 12 from baseline;Safety Endpoint: The incidence of all adverse events including treatment emergent adverse events (TEAEs) and serious adverse events.Timepoint: Throughout the study period | — |
Countries
India
Contacts
Public ContactMr Abhijit Vaidya
Cipla Limited
Outcome results
None listed