Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Sun Pharmaceutical Industries Ltd. (SPIL)
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male or female patients more than and equal to 18 years of age 2 Patients diagnosed with COPD in accordance with the definition by the American Thoracic Society or European Respiratory Society, diagnosis requires spirometry, a post-bronchodilator forced expiratory volume in one second FEV1 by forced vital capacity FVC less than 0.7 confirms the presence of airflow limitation that is not fully reversible 3 Patients with FEV1 less than 80 percentage of predicted value 4 Patients with COPD symptoms like dyspnea, cough, sputum production, etc. 5 Patients in whom FEV1, FVC, and symptoms assessment have been conducted as part of routine clinical practice and data are available for the same at least at baseline and 6 1 weeks 6 Patients on stable COPD treatment ICS, LABA or LAMA, SABA, SAMA as monotherapy or their combinations for at least 3 months prior to initiation of treatment with acebrophylline
Exclusion criteria
Exclusion criteria: 1 Presence of active respiratory tract infection including tuberculosis 2 Pregnant or breastfeeding women 3 Patients with comorbid lung diseases such as cystic fibrosis, bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease 5 Patients with hypersensitivity to ambroxol, acebrophylline, theophylline or any other xanthine derivative 6 Patients receiving any other concomitant medications for COPD during the study except continuation of the allowed medications as per inclusion criteria 7 Patients on methylxanthines, phosphodiesterase-4 inhibitors, mucolytics, or any other drug including acebrophylline used for management of COPD in the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in forced expiratory volume (FEV1) from baseline to 6 1 weeks in patients with COPDTimepoint: Baseline to 6 1 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in forced expiratory volume (FEV1) from baseline to end of study period, upon stratification of patients based on duration of treatment and based on 2024 COPD GOLD Grading and Severity of airflow obstructionTimepoint: Baseline to end of study;Change in FEV1/FVC ratio from baseline to end of study period, upon stratification of patients based on duration of treatment and based on 2024 COPD GOLD Grading and Severity of airflow obstructionTimepoint: Baseline to end of study;Changes in COPD symptoms (dyspnea, cough, sputum production, etc.) from baseline to end of study period, upon stratification of patients based on duration of treatment and based on 2024 COPD GOLD Grading and Severity of airflow obstructionTimepoint: Baseline to end of study;Proportion of patients with adverse events (AEs) and serious AEs (SAEs) from baseline to end of study periodTimepoint: Baseline to end of study;Change in the number of COPD exacerbations from baseline to end of study period, upon stratification of patients based on duration of treatment and based on 2024 COPD GOLD Grading and Severity of airflow obstructionTimepoint: Baseline to end of study | — |
Countries
India
Contacts
Public ContactMs Colette Pinto
Sun Pharmaceutical Industries Ltd.
Outcome results
None listed