Trial | NCT01032304  Report issue

Title

The Efficacy and Safety of Erdosteine in Chronic Obstructive Pulmonary Disease (COPD)
The Efficacy and Safety of Erdosteine in the Long-term Therapy of Chronic Obstructive Pulmonary Disease (COPD). A 12-month, Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    erdosteine ...

  • Study Participants

    492
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.
Study Started
Aug 31
2009
Primary Completion
Mar 31
2014
Study Completion
Sep 30
2015
Anticipated
Last Update
Jun 13
2014
Estimate

Drug Erdosteine

One 300 mg capsule twice a day

Drug Placebo

One capsule twice a day

Erdosteine Experimental

600 mg/day for 12 months

Placebo Placebo Comparator

Placebo for 12 months

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
No Results Posted