The Efficacy and Safety of Erdosteine in Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT01032304
Last Updated: 2014-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
492 participants
INTERVENTIONAL
2009-08-31
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Erdosteine
600 mg/day for 12 months
Erdosteine
One 300 mg capsule twice a day
Placebo
Placebo for 12 months
Placebo
One capsule twice a day
Interventions
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Erdosteine
One 300 mg capsule twice a day
Placebo
One capsule twice a day
Eligibility Criteria
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Inclusion Criteria
* At least 2 exacerbations in the previous 2-12 months
Exclusion Criteria
* Diagnosis of asthma and/or other relevant lung diseases
* COPD stage IV
* Unstable concurrent diseases
40 Years
80 Years
ALL
No
Sponsors
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Edmond Pharma
INDUSTRY
Responsible Party
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Locations
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Campus Gasthuisberg Dep.t Longfunctiemetingen
Leuven, , Belgium
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
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, , Czechia
Lerymed spol. s.r.o.
Prague, , Czechia
Plicnì Ambulance
Prostějov, , Czechia
Plicnì M.I.O., spol. s.r.o.
Příbor, , Czechia
Plicnì Ordinace
Strakonice, , Czechia
Nemonice Znojmo
Znojmo, , 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, , Italy
Ospedale San Carlo Borromeo, Dipartimento Broncocardiopneumologico
Milan, , Italy
Szpital Uniwersytecki 2
Bydgoszczy, , 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, , 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, , Slovakia
Inspiro
Humenné, , Slovakia
Specializovana NemocnicaSvorada Zobor n.o.
Nitra, , Slovakia
Narodny Ustav Tuberculozy
Vyšné Hágy, , 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
Countries
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References
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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.
Other Identifiers
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ERD-01-08/EP
Identifier Type: -
Identifier Source: org_study_id
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