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. - Study RESTORE

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease; MedDRA version: 12.0Level: LLTClassification code 10009033Term: Chronic obstructive pulmonary disease

• Registration Number: EUCTR2008-008192-34-FR
• Lead Sponsor: Edmond Pharma S.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-17
• Study Completion: 2014-02-03
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 467

Inclusion Criteria

Outpatients of both sexes, aged between 40 and 80 years. Diagnosis of COPD (Stage II and III according to GOLD 2007) as follows: post-bronchodilator FEV1/FVC < 70% and FEV1 between 30%-70% predicted (and at least 0.7 L absolute value).
Current or past cigarette smokers with an history of smoking of at least 10 pack-years. On a stable therapeutic regimen for COPD for at least 8 weeks prior to inclusion. Having experienced at least 2 acute exacerbations of COPD requiring medical intervention within 2-12 months prior to inclusion. Presence of chronic COPD symptoms (cough, sputum production, dyspnoea), and a mean cough and sputum score (derived from BCSS) of at least 1.5 for each symptom during run-in. Written informed consent to participate.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Female subjects: pregnant, lactating mother or lack of efficient contraception in a subject with child-bearing potential. Acute exacerbation of COPD within 8 weeks prior to inclusion. Treatment with antibiotics and/or systemic steroids and/or hospitalisations within 8 weeks prior to inclusion. COPD stage IV. Current or past diagnosis of asthma. Clinically significant or unstable concurrent disease, including significant pulmonary disease (e.g. tuberculosis, bronchiectasis, cystic fibrosis, lung cancer). Significant renal impairment as indicated by creatinine clearance < 25 ml/ min. Active peptic ulcer. Long term oxygen therapy. Known or suspected hypersensitivity to erdosteine. Participation in another clinical trial with an investigational drug within 60 days prior to inclusion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to evaluate the efficacy of erdosteine, compared to placebo, in reducing the number of acute exacerbations over a 12-month treatment period in patients with moderate-to-severe COPD.;Secondary Objective: Secondary objectives of the study will be to investigate the effects of erdosteine on chronic respiratory symptoms and quality of life, pulmonary function and exercise performance, and disease-related costs. Moreover, the safety and tolerability of the drug during long-term treatment administration will be assessed.;Primary end point(s): Number of acute exacerbations of COPD experienced by the patients in the two treatment groups during the 12-month treatment period.<br>Acute COPD exacerbations are defined as a symptomatic worsening requiring treatment with antibiotics, systemic corticosteroids, or both. <br>Exacerbations will be reviewed by the Steering Committee before statistical analysis<br>