Overview
The Efficacy and Safety of Erdosteine in Chronic Obstructive Pulmonary Disease (COPD)
Status:
Unknown status
Unknown status
Trial end date:
2015-09-01
2015-09-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The aim of the study is to evaluate the effect of erdosteine, compared to placebo, on exacerbation rate over a 12-month treatment period in patients with moderate-to-severe COPD. Moreover, the effects of erdosteine on pulmonary function parameters, clinical symptoms and quality of life, and the long-term safety of the drug will be assessed.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Edmond PharmaTreatments:
Erdosteine
Criteria
Inclusion Criteria:- COPD stage II-III GOLD
- At least 2 exacerbations in the previous 2-12 months
Exclusion Criteria:
- Acute exacerbations in the 2 months prior to enrolment
- Diagnosis of asthma and/or other relevant lung diseases
- COPD stage IV
- Unstable concurrent diseases