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The Efficacy and Safety of Erdosteine in Chronic Obstructive Pulmonary Disease (COPD)

NCT01032304 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 492

Last updated 2014-06-13

No results posted yet for this study

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.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

Erdosteine

One 300 mg capsule twice a day

DRUG

Placebo

One capsule twice a day

Sponsors & Collaborators

  • Edmond Pharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2014-03-31
Completion
2015-09-30

Countries

  • Belgium
  • Bulgaria
  • Czechia
  • Denmark
  • France
  • Italy
  • Poland
  • Romania
  • Slovakia
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01032304 on ClinicalTrials.gov