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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01032304

Acronym

RESTORE

Enrollment

492

Registered

2009-12-15

Start date

2009-08-31

Completion date

2015-09-30

Last updated

2014-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Brief 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.

Interventions

DRUGErdosteine

One 300 mg capsule twice a day

DRUGPlacebo

One capsule twice a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
number of acute exacerbations	12 months

Secondary

Measure	Time frame
spirometry parameters	12 months
COPD symptoms	12 months
Quality of life	12 months
Safety and tolerability of erdosteine	12 months

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026