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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Edmond Pharma.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Edmond Pharma
ClinicalTrials.gov Identifier:
NCT01032304
First received: December 11, 2009
Last updated: October 19, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: Erdosteine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Edmond Pharma:

Primary Outcome Measures:
  • number of acute exacerbations [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • spirometry parameters [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • COPD symptoms [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Safety and tolerability of erdosteine [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 492
Study Start Date: August 2009
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032304

Contacts
Contact: Maria Ballabio, MD +39 02 3320781 ext 225 medical.director@edmondpharma.it

Locations
Czech Republic
Department of Respiratory Medicine, Faculty Hospital Recruiting
Olomouc, Czech Republic
Principal Investigator: Vitezslav Kolek         
Denmark
Department of Respiratory Diseases, Copenhagen University Hospital Recruiting
Hvidovre, Denmark
Principal Investigator: Peter Lange         
France
Service de Pneumologie, Hopital Bichat Recruiting
Paris, France
Principal Investigator: Michael Aubier         
Service de Pneumologie, Hopital Bois-Guillaume Recruiting
Rouen, France
Principal Investigator: Jean Francois Muir         
Italy
U.O. Pneumologia Recruiting
Bussolengo, Italy
Principal Investigator: Roberto Dal Negro         
Ospedale Careggi, Malattie dell'Apparato Respiratorio Recruiting
Firenze, Italy
Principal Investigator: Giovanni Fontana         
U.O. Pneumologia Recruiting
Macerata, Italy
Principal Investigator: Alberto Tubaldi         
Ospedale San Carlo Borromeo, Dipartimento Broncocardiopneumologico Recruiting
Milano, Italy
Principal Investigator: Sandro Amaducci         
Poland
Klinika Pulmonologii II Katedry, Collegium Medicum Uniwersytetu Recruiting
Krakow, Poland
Principal Investigator: Ewa Niżankowska-Mogilnicka         
Katedra Pulmunologii i Alergologii, Klinika Gruźlicy Uniwersytetu Medycznego Completed
Lodz, Poland
Katedra i klinika Pulmonologii, Uniwersytet Medyczny Recruiting
Poznan, Poland
Principal Investigator: Halina Batura-Gabryel         
Katedra i Klinika Pneumonologii, Warszawski Uniwersytet Medyczny Recruiting
Warszawa, Poland
Principal Investigator: Ryszarda Chazan         
Romania
Institutul de Pneumoftiziologie "Marius Nasta" Recruiting
Bucharest, Romania
Principal Investigator: Florin Mihaltan         
Principal Investigator: Roxandra Ulmeanu         
Spitalul de Pneumoftiziologie "Leon Daniello" Recruiting
Cluj, Romania
Principal Investigator: Doina Todea         
Principal Investigator: Monica Carmen Pop         
Spitalul Clinic de Pneumoftiziologie Recruiting
Iasi, Romania
Principal Investigator: Traian Mihaescu         
Clinica Pneumologie I, Spitalul Clinic Judetean Mureş Recruiting
Targu Mures, Romania
Principal Investigator: Gabriela Jimborean         
Spitalul de Pneumoftiziologie "Victor Babes" Recruiting
Timisoara, Romania
Principal Investigator: Voicu Tudorache         
United Kingdom
Regional Respiratory Centre, Belfast City Hospital Recruiting
Belfast, United Kingdom
Principal Investigator: Lorcan McGarvey         
Aintree Chest Centre, University Hospital Aintree Recruiting
Liverpool, United Kingdom
Principal Investigator: Lisa Davies         
Sponsors and Collaborators
Edmond Pharma
  More Information

No publications provided

Responsible Party: Maria Ballabio, MD, Edmond Pharma
ClinicalTrials.gov Identifier: NCT01032304     History of Changes
Other Study ID Numbers: ERD-01-08/EP
Study First Received: December 11, 2009
Last Updated: October 19, 2010
Health Authority: Italy: Ethics Committee
Denmark: Danish Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Czech Republic: State Institute for Drug Control
Poland: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Romania: National Medicines Agency

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Erdosteine
Expectorants
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014