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

Edmond Pharma

Status and phase: Unknown; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Erdosteine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01032304

ERD-01-08/EP

Details and patient eligibility

About

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.

Enrollment: 492 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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492 participants in 2 patient groups, including a placebo group

Erdosteine

Experimental group

Description:

600 mg/day for 12 months

Treatment:

Drug: Erdosteine

Placebo

Placebo Comparator group

Description:

Placebo for 12 months

Treatment:

Drug: Placebo