The Efficacy and Safety of Erdosteine in Chronic Obstructive Pulmonary Disease (COPD)
RESTORE
1 other identifier
interventional
492
10 countries
46
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2009
Longer than P75 for phase_3
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 11, 2009
CompletedFirst Posted
Study publicly available on registry
December 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedJune 13, 2014
June 1, 2014
4.6 years
December 11, 2009
June 12, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
number of acute exacerbations
12 months
Secondary Outcomes (4)
spirometry parameters
12 months
COPD symptoms
12 months
Quality of life
12 months
Safety and tolerability of erdosteine
12 months
Study Arms (2)
Erdosteine
EXPERIMENTAL600 mg/day for 12 months
Placebo
PLACEBO COMPARATORPlacebo for 12 months
Interventions
Eligibility Criteria
You may qualify if:
- COPD stage II-III GOLD
- At least 2 exacerbations in the previous 2-12 months
You may not qualify if:
- Acute exacerbations in the 2 months prior to enrolment
- Diagnosis of asthma and/or other relevant lung diseases
- COPD stage IV
- Unstable concurrent diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Edmond Pharmalead
Study Sites (46)
Campus Gasthuisberg Dep.t Longfunctiemetingen
Leuven, B-3000, Belgium
ASMOH-MC "Sveti Panteleiomon"
Sofia, 1463, Bulgaria
Clinic for emergency Medicine and Intensive care, Pneumology and Physiatry
Sofia, Bulgaria
Clinic of Pulmonary Disease-Military Medical Academy
Sofia, Bulgaria
Clinical of Pneumology and Physiatry
Varna, Bulgaria
Plicnì Ordinace
Havlìckuv Brod, Czechia
Poliklinica Moravsky Krumlov
Moravský Krumlov, Czechia
Department of Respiratory Medicine, Faculty Hospital
Olomouc, Czechia
Lipa Centrum Nove Butovice
Prague, 15900, Czechia
Lerymed spol. s.r.o.
Prague, Czechia
Plicnì Ambulance
Prostějov, 79601, Czechia
Plicnì M.I.O., spol. s.r.o.
Příbor, Czechia
Plicnì Ordinace
Strakonice, 38601, Czechia
Nemonice Znojmo
Znojmo, 66902, Czechia
Department of Respiratory Diseases, Copenhagen University Hospital
Hvidovre, Denmark
Service de Pneumologie, Hopital Bichat
Paris, France
Service de Pneumologie, Hopital Bois-Guillaume
Rouen, France
UOC Pneumologia Riabilitativa INRCA
Casatenovo, Lecco, Italy
UOC di Pneumologia-Ospedale Mater Salutis
Legnago, Verona, Italy
Dip. Pneumologia Osp. G. Rummo
Benevento, Italy
U.O. Pneumologia
Bussolengo, Italy
UOC di Pneumologia- Ospedale Civile di Massa e Carrara
Carrara, Italy
Ospedale Careggi, Malattie dell'Apparato Respiratorio
Florence, Italy
UOC Pneumologia Osp. Vito Fazzi
Lecce, Italy
U.O. Pneumologia
Macerata, Italy
UO di Pneumologia Osp. San Paolo
Milan, 20100, Italy
Ospedale San Carlo Borromeo, Dipartimento Broncocardiopneumologico
Milan, Italy
Szpital Uniwersytecki 2
Bydgoszczy, 85168, Poland
Klinika Pulmonologii II Katedry, Collegium Medicum Uniwersytetu
Krakow, Poland
Katedra Pulmunologii i Alergologii, Klinika Gruźlicy Uniwersytetu Medycznego
Lodz, Poland
Katedra i klinika Pulmonologii, Uniwersytet Medyczny
Poznan, Poland
NZOZ "Darmeticus"
Warsaw, 04364, Poland
Katedra i Klinika Pneumonologii, Warszawski Uniwersytet Medyczny
Warsaw, Poland
Institutul de Pneumoftiziologie "Marius Nasta"
Bucharest, Romania
Novo Medica
Bucharest, Romania
Spitalul de Pneumoftiziologie "Leon Daniello"
Cluj-Napoca, Romania
Spitalul Clinic de Pneumoftiziologie
Iași, Romania
Clinica Pneumologie I, Spitalul Clinic Judetean Mureş
Târgu Mureş, Romania
Spitalul de Pneumoftiziologie "Victor Babes"
Timișoara, Romania
Nemocnica s Poliklinicou "Svateho Jakuba"n.o.
Bardejov, 08501, Slovakia
Inspiro
Humenné, 06601, Slovakia
Specializovana NemocnicaSvorada Zobor n.o.
Nitra, 94901, Slovakia
Narodny Ustav Tuberculozy
Vyšné Hágy, 05984, Slovakia
Regional Respiratory Centre, Belfast City Hospital
Belfast, United Kingdom
Cardiovascular and Respiratory Studies Department
Hull, United Kingdom
Aintree Chest Centre, University Hospital Aintree
Liverpool, United Kingdom
Related Publications (1)
Dal Negro RW, Wedzicha JA, Iversen M, Fontana G, Page C, Cicero AF, Pozzi E, Calverley PMA; RESTORE group; RESTORE study. Effect of erdosteine on the rate and duration of COPD exacerbations: the RESTORE study. Eur Respir J. 2017 Oct 12;50(4):1700711. doi: 10.1183/13993003.00711-2017. Print 2017 Oct.
PMID: 29025888DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2009
First Posted
December 15, 2009
Study Start
August 1, 2009
Primary Completion
March 1, 2014
Study Completion
September 1, 2015
Last Updated
June 13, 2014
Record last verified: 2014-06