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

June 12, 2014 updated by: Edmond Pharma

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

492

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, B-3000
        • Campus Gasthuisberg Dep.t Longfunctiemetingen
  • Bulgaria
      • Sofia, Bulgaria, 1463
        • ASMOH-MC "Sveti Panteleiomon"
      • Sofia, Bulgaria
        • Clinic for emergency Medicine and Intensive care, Pneumology and Physiatry
      • Sofia, Bulgaria
        • Clinic of Pulmonary Disease-Military Medical Academy
      • Varna, Bulgaria
        • Clinical of Pneumology and Physiatry
  • Czech Republic
      • Havlìckuv Brod, Czech Republic
        • Plicnì Ordinace
      • Moravsky Krumlov, Czech Republic
        • Poliklinica Moravsky Krumlov
      • Olomouc, Czech Republic
        • Department of Respiratory Medicine, Faculty Hospital
      • Praha, Czech Republic, 15900
        • Lipa Centrum Nove Butovice
      • Praha, Czech Republic
        • LERYMED spol. s.r.o.
      • Pribor, Czech Republic
        • Plicnì M.I.O., spol. s.r.o.
      • Prostejov, Czech Republic, 79601
        • Plicni ambulance
      • Strakonice, Czech Republic, 38601
        • Plicnì Ordinace
      • Znojmo, Czech Republic, 66902
        • Nemonice Znojmo
  • Denmark
      • Hvidovre, Denmark
        • Department of Respiratory Diseases, Copenhagen University Hospital
  • France
      • Paris, France
        • Service de Pneumologie, Hopital Bichat
      • Rouen, France
        • Service de Pneumologie, Hopital Bois-Guillaume
  • Italy
      • Benevento, Italy
        • Dip. Pneumologia Osp. G. Rummo
      • Bussolengo, Italy
        • U.O. Pneumologia
      • Carrara, Italy
        • UOC di Pneumologia- Ospedale Civile di Massa e Carrara
      • Firenze, Italy
        • Ospedale Careggi, Malattie dell'Apparato Respiratorio
      • Lecce, Italy
        • UOC Pneumologia Osp. Vito Fazzi
      • Macerata, Italy
        • U.O. Pneumologia
      • Milano, Italy, 20100
        • UO di Pneumologia Osp. San Paolo
      • Milano, Italy
        • Ospedale San Carlo Borromeo, Dipartimento Broncocardiopneumologico
    • Lecco
      • Casatenovo, Lecco, Italy
        • UOC Pneumologia Riabilitativa INRCA
    • Verona
      • Legnago, Verona, Italy
        • UOC di Pneumologia-Ospedale Mater Salutis
  • Poland
      • Bydgoszczy, Poland, 85168
        • Szpital Uniwersytecki 2
      • Krakow, Poland
        • Klinika Pulmonologii II Katedry, Collegium Medicum Uniwersytetu
      • Lodz, Poland
        • Katedra Pulmunologii i Alergologii, Klinika Gruźlicy Uniwersytetu Medycznego
      • Poznan, Poland
        • Katedra i klinika Pulmonologii, Uniwersytet Medyczny
      • Warsawa, Poland, 04364
        • NZOZ "Darmeticus"
      • Warszawa, Poland
        • Katedra i Klinika Pneumonologii, Warszawski Uniwersytet Medyczny
  • Romania
      • Bucharest, Romania
        • Institutul de Pneumoftiziologie "Marius Nasta"
      • Bucharest, Romania
        • Novo Medica
      • Cluj, Romania
        • Spitalul de Pneumoftiziologie "Leon Daniello"
      • Iasi, Romania
        • Spitalul Clinic de Pneumoftiziologie
      • Targu Mures, Romania
        • Clinica Pneumologie I, Spitalul Clinic Judetean Mureş
      • Timisoara, Romania
        • Spitalul de Pneumoftiziologie "Victor Babes"
  • Slovakia
      • Bardejov, Slovakia, 08501
        • Nemocnica s Poliklinicou "Svateho Jakuba"n.o.
      • Humenne, Slovakia, 06601
        • Inspiro
      • Nitra, Slovakia, 94901
        • Specializovana NemocnicaSvorada Zobor n.o.
      • Vysne Hagy, Slovakia, 05984
        • Narodny Ustav Tuberculozy
  • United Kingdom
      • Belfast, United Kingdom
        • Regional Respiratory Centre, Belfast City Hospital
      • Hull, United Kingdom
        • Cardiovascular and Respiratory Studies Department
      • Liverpool, United Kingdom
        • Aintree Chest Centre, University Hospital Aintree

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erdosteine
600 mg/day for 12 months
Drug: Erdosteine
One 300 mg capsule twice a day
Placebo Comparator: Placebo
Placebo for 12 months
Drug: Placebo
One capsule twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of acute exacerbations
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
spirometry parameters
Time Frame: 12 months
12 months
COPD symptoms
Time Frame: 12 months
12 months
Quality of life
Time Frame: 12 months
12 months
Safety and tolerability of erdosteine
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edmond Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

March 1, 2014

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

December 11, 2009

First Submitted That Met QC Criteria

December 13, 2009

First Posted (Estimate)

December 15, 2009

Study Record Updates

Last Update Posted (Estimate)

June 13, 2014

Last Update Submitted That Met QC Criteria

June 12, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERD-01-08/EP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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