Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Intervention1: Ensifentrine inhalation suspension: 3mg/2.5ml for oral inhalation. For use with a standard jet nebulizer. Twice Daily For 24 weeks.
Control Intervention1: Matching Placebo: for oral in
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Willing and able to provide written informed consent prior to any study related activities being performed and to follow the protocol requirements Male and female subjects aged 40 years and above with documented diagnosis of COPD based on Global Initiative for Chronic Obstructive Lung Disease GOLD report 2025 Subject has a current or past cigarette smoking history OR Nonsmoking history of exposure to noxious stimuli OR Occupational risk factor exposure for at least 20 years which led to the development of COPD Subject with FEV1 by FVC ratio of less than 0.7 post bronchodilator at screening and with postbronchodilator FEV1 of less than equal to 70 percentgage to more than equal to 30 percentage of predicted normal Subjects with a grade of more than equal to 2 on the Modified Medical Research Council mMRC Dyspnea Scale Subjects on stable maintenance therapy of long acting beta agonists LABA or long acting muscarinic antagonists LAMA or LABA and LAMA or Inhaled corticosteroids ICS and LABA and LAMA or ICS and LABA for at least one month Female subjects of childbearing potential with negative urine pregnancy test Female subjects of childbearing practicing two acceptable methods of contraception during the study and for at least 1 month after completion of study drug dosing
Exclusion criteria
Exclusion criteria: Subject with history of intolerance or hypersensitivity to levosalbutamol or Ensifentrine or to similar class of drugs or to any of the excipients of the formulations Subject with history of life-threatening COPD including intensive care unit admission and or requiring intubation Subject with history of hospitalization for COPD or COPD exacerbation or pneumonia or a need for increase in treatment for COPD within 60 days prior to screening Subjects having history of taking prohibited medications prior to screening visit and are unwilling or unable to discontinue the use of prohibited medications during the study Subject requiring long term oxygen use Subject with lower respiratory tract infection Subjects with other respiratory disorders Subject with historical or current evidence of clinically significant cardiovascular disease Subject with chronic uncontrolled disease Subject with unstable liver disease Subject with history of or current malignancy of any organ system Subject with creatinine clearance CrCl less than 30 mL per min Subject with abnormal liver function test Subject with abnormal findings on physical examination, abnormal laboratory and ECG findings Subjects with chest Xray with clinically significant abnormalities not attributable to COPD Subject with history of drug or alcohol abuse Subjects with positive serology for HBV HCV HIV Female subjects who are pregnant or lactating or planning to become pregnant or is of childbearing potential and not using contraceptive method.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in average (FEV1) area under curveTimepoint: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in average FEV1 area under curveTimepoint: Day 1 and Week 24 from baseline;Change in Peak FEV1Timepoint: Day 1, Week 12 and Week 24 from baseline;Change in morning trough FEV1Timepoint: Week 12 and Week 24 from baseline;Change in Evaluating-Respiratory Symptoms (E-RS), St. George s Respiratory Questionnaire (SGRQ) and Transition Dyspnea Index (TDI)Timepoint: Week 12 and Week 24 from baseline;Rescue medication usageTimepoint: During 24 weeks;Safety Endpoint The incidence of all adverse events including treatment emergent adverse events (TEAEs) and serious adverse events reported Timepoint: During 24 Weeks | — |
Countries
India
Contacts
Public ContactMr Abhijit Vaidya
Cipla Limited
Outcome results
None listed