Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Intervention1: Group 1 Erdosteine and usual care
Group 2 Usual care alone: Intervention group n is 60 Erdosteine 300mg twice daily by oral route and usual COPD treatment
Control group n is 60 Usual
Sponsors
Cipla Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Age more than equal to 40 years Male and female and others Current or Ex smokers With more than equal to 10 pack years treated as outpatients This will mean that the major proportion of participants will be male A previously and currently diagnosed case of COPD confirmed by a doctor with GOLD 2025 criteria stage I II III defined by the presence of respiratory symptoms risk factors and post bronchodilator FEV1 by FVC less than 70 percent and FEV1 between more than equal to 80 percent predicted for stage I 50 percent less than equal to FEV1 less than 80 percent predicted for stage II and 30 percent less than equal to FEV1 less than 50percent predicted for stage III at screening visit A stable therapeutic regimen for more than equal to 8 weeks History of one or more acute exacerbations in the past 12 months but no exacerbations in the last 2 months Patients stabilized on treatment Stabilized is defined as patients who had no exacerbation in the last 2 months and they should also be on a stable dose of COPD pharmacotherapy for the past 2 months Patients who have not previously used Erdosteine past 6 months Patients who are on Oral NAC mucoactive drug need to have a washout period discontinuation of mucolytics of 1 month and then be included in the trial
Exclusion criteria
Exclusion criteria: Participants unwilling or unable to perform spirometry Patients unwilling to come for the follow up visits History and ongoing asthma bronchiectasis or any other respiratory condition other than COPD that may affect respiratory disease management Subject to be excluded if they have any of the following pneumonia acute heart failure acute respiratory acidosis needing non invasive ventilation AECOPD treated with antibiotics or systemic corticosteroids in the previous 8 weeks or any other medical problems that the in the opinion of the investigator would interfere with the conduct of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in BCSS Breathlessness Cough and Sputum Scale score Mean change in CAT COPD Assessment Test score from baseline visit V0 to End of study visit V3 Mean changes in SGRQ C from baseline V0 to V1 V2 and V3 Comparisons between the two treatment groups Erdosteine 300 mg twice daily vs Usual COPD treatment will be conducted using Independent t test for normally distributed data & Mann Whitney U test for non normally distributed data Within groups changes will be analyzed using Paired sample t test if normally distributed and Wilcoxon signed rank test if non normally distributed The average number of exacerbations between groups will be analyzed using independent t test or Mann Whitney U test The number of mild moderate and severe exacerbations over 24 weeks will be summarizedTimepoint: Screening V0 Baseline Randomization V1 1 month from baseline V2 3 months from baseline V3 6 months from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Sundeep Salvi
Chest Research and Training CREST
Outcome results
None listed