The Efficacy and Safety of Erdosteine in Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Drug: Placebo
- Registration Number
- NCT01032304
- Lead Sponsor
- Edmond Pharma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 492
- COPD stage II-III GOLD
- At least 2 exacerbations in the previous 2-12 months
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo for 12 months Erdosteine Erdosteine 600 mg/day for 12 months
- Primary Outcome Measures
Name Time Method number of acute exacerbations 12 months
- Secondary Outcome Measures
Name Time Method spirometry parameters 12 months COPD symptoms 12 months Quality of life 12 months Safety and tolerability of erdosteine 12 months
Trial Locations
- Locations (44)
Poliklinica Moravsky Krumlov
๐จ๐ฟMoravsky Krumlov, Czech Republic
Clinic of Pulmonary Disease-Military Medical Academy
๐ง๐ฌSofia, Bulgaria
Campus Gasthuisberg Dep.t Longfunctiemetingen
๐ง๐ชLeuven, Belgium
Lipa Centrum Nove Butovice
๐จ๐ฟPraha, Czech Republic
Institutul de Pneumoftiziologie "Marius Nasta"
๐ท๐ดBucharest, Romania
Novo Medica
๐ท๐ดBucharest, Romania
Dip. Pneumologia Osp. G. Rummo
๐ฎ๐นBenevento, Italy
UOC di Pneumologia- Ospedale Civile di Massa e Carrara
๐ฎ๐นCarrara, Italy
UO di Pneumologia Osp. San Paolo
๐ฎ๐นMilano, Italy
Service de Pneumologie, Hopital Bois-Guillaume
๐ซ๐ทRouen, France
Klinika Pulmonologii II Katedry, Collegium Medicum Uniwersytetu
๐ต๐ฑKrakow, Poland
Katedra i klinika Pulmonologii, Uniwersytet Medyczny
๐ต๐ฑPoznan, Poland
U.O. Pneumologia
๐ฎ๐นMacerata, Italy
UOC Pneumologia Osp. Vito Fazzi
๐ฎ๐นLecce, Italy
Clinical of Pneumology and Physiatry
๐ง๐ฌVarna, Bulgaria
Plicnรฌ Ordinace
๐จ๐ฟStrakonice, Czech Republic
Plicnรฌ M.I.O., spol. s.r.o.
๐จ๐ฟPribor, Czech Republic
Department of Respiratory Diseases, Copenhagen University Hospital
๐ฉ๐ฐHvidovre, Denmark
Ospedale San Carlo Borromeo, Dipartimento Broncocardiopneumologico
๐ฎ๐นMilano, Italy
Clinic for emergency Medicine and Intensive care, Pneumology and Physiatry
๐ง๐ฌSofia, Bulgaria
Service de Pneumologie, Hopital Bichat
๐ซ๐ทParis, France
ASMOH-MC "Sveti Panteleiomon"
๐ง๐ฌSofia, Bulgaria
UOC di Pneumologia-Ospedale Mater Salutis
๐ฎ๐นLegnago, Verona, Italy
Plicnรฌ Ambulance
๐จ๐ฟProstejov, Czech Republic
UOC Pneumologia Riabilitativa INRCA
๐ฎ๐นCasatenovo, Lecco, Italy
Ospedale Careggi, Malattie dell'Apparato Respiratorio
๐ฎ๐นFirenze, Italy
Szpital Uniwersytecki 2
๐ต๐ฑBydgoszczy, Poland
Katedra i Klinika Pneumonologii, Warszawski Uniwersytet Medyczny
๐ต๐ฑWarszawa, Poland
Clinica Pneumologie I, Spitalul Clinic Judetean Mureล
๐ท๐ดTargu Mures, Romania
Inspiro
๐ธ๐ฐHumenne, Slovakia
Spitalul de Pneumoftiziologie "Victor Babes"
๐ท๐ดTimisoara, Romania
Specializovana NemocnicaSvorada Zobor n.o.
๐ธ๐ฐNitra, Slovakia
Cardiovascular and Respiratory Studies Department
๐ฌ๐งHull, United Kingdom
Regional Respiratory Centre, Belfast City Hospital
๐ฌ๐งBelfast, United Kingdom
Aintree Chest Centre, University Hospital Aintree
๐ฌ๐งLiverpool, United Kingdom
Spitalul de Pneumoftiziologie "Leon Daniello"
๐ท๐ดCluj, Romania
NZOZ "Darmeticus"
๐ต๐ฑWarsawa, Poland
Nemocnica s Poliklinicou "Svateho Jakuba"n.o.
๐ธ๐ฐBardejov, Slovakia
Narodny Ustav Tuberculozy
๐ธ๐ฐVysne Hagy, Slovakia
Lerymed spol. s.r.o.
๐จ๐ฟPraha, Czech Republic
Katedra Pulmunologii i Alergologii, Klinika Gruลบlicy Uniwersytetu Medycznego
๐ต๐ฑLodz, Poland
Spitalul Clinic de Pneumoftiziologie
๐ท๐ดIasi, Romania
Department of Respiratory Medicine, Faculty Hospital
๐จ๐ฟOlomouc, Czech Republic
Nemonice Znojmo
๐จ๐ฟZnojmo, Czech Republic