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
Recruitment status was Recruiting
Sponsor:
Edmond Pharma
Information provided by:
Edmond Pharma
ClinicalTrials.gov Identifier:
NCT01032304
First received: December 11, 2009
Last updated: October 19, 2010
Last verified: October 2010
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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 May 19, 2013