Clinical trial NCT01032304: The Efficacy and Safety of Erdosteine in Chronic Obstructive Pulmonary Disease (COPD)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Edmond Pharma
Sponsor class: INDUSTRY
First posted: 2009-12-15
Enrollment: 492
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: number of acute exacerbations
timeFrame: 12 months
Secondary outcomes:
measure: spirometry parameters
timeFrame: 12 months
measure: COPD symptoms
timeFrame: 12 months
measure: Quality of life
timeFrame: 12 months
measure: Safety and tolerability of erdosteine
timeFrame: 12 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Campus Gasthuisberg Dep.t Longfunctiemetingen
city: Sofia
country: Bulgaria
facility: ASMOH-MC "Sveti Panteleiomon"
city: Sofia
country: Bulgaria
facility: Clinic for emergency Medicine and Intensive care, Pneumology and Physiatry
city: Sofia
country: Bulgaria
facility: Clinic of Pulmonary Disease-Military Medical Academy
city: Varna
country: Bulgaria
facility: Clinical of Pneumology and Physiatry
city: Havlìckuv Brod
country: Czech Republic
facility: Plicnì Ordinace
city: Moravsky Krumlov
country: Czech Republic
facility: Poliklinica Moravsky Krumlov
city: Olomouc
country: Czech Republic
facility: Department of Respiratory Medicine, Faculty Hospital
city: Praha
country: Czech Republic
facility: Lipa Centrum Nove Butovice
city: Praha
country: Czech Republic
facility: Lerymed spol. s.r.o.
city: Pribor
country: Czech Republic
facility: Plicnì M.I.O., spol. s.r.o.
city: Prostejov
country: Czech Republic
facility: Plicnì Ambulance
city: Strakonice
country: Czech Republic
facility: Plicnì Ordinace
city: Znojmo
country: Czech Republic
facility: Nemonice Znojmo
city: Hvidovre
country: Denmark
facility: Department of Respiratory Diseases, Copenhagen University Hospital
city: Paris
country: France
facility: Service de Pneumologie, Hopital Bichat
city: Rouen
country: France
facility: Service de Pneumologie, Hopital Bois-Guillaume
city: Casatenovo
country: Italy
facility: UOC Pneumologia Riabilitativa INRCA
state: Lecco
city: Legnago
country: Italy
facility: UOC di Pneumologia-Ospedale Mater Salutis
state: Verona
city: Benevento
country: Italy
facility: Dip. Pneumologia Osp. G. Rummo
city: Bussolengo
country: Italy
facility: U.O. Pneumologia
city: Carrara
country: Italy
facility: UOC di Pneumologia- Ospedale Civile di Massa e Carrara
city: Firenze
country: Italy
facility: Ospedale Careggi, Malattie dell'Apparato Respiratorio
city: Lecce
country: Italy
facility: UOC Pneumologia Osp. Vito Fazzi
city: Macerata
country: Italy
facility: U.O. Pneumologia
city: Milano
country: Italy
facility: UO di Pneumologia Osp. San Paolo
city: Milano
country: Italy
facility: Ospedale San Carlo Borromeo, Dipartimento Broncocardiopneumologico
city: Bydgoszczy
country: Poland
facility: Szpital Uniwersytecki 2
city: Krakow
country: Poland
facility: Klinika Pulmonologii II Katedry, Collegium Medicum Uniwersytetu
city: Lodz
country: Poland
facility: Katedra Pulmunologii i Alergologii, Klinika Gruźlicy Uniwersytetu Medycznego
city: Poznan
country: Poland
facility: Katedra i klinika Pulmonologii, Uniwersytet Medyczny
city: Warsawa
country: Poland
facility: NZOZ "Darmeticus"
city: Warszawa
country: Poland
facility: Katedra i Klinika Pneumonologii, Warszawski Uniwersytet Medyczny
city: Bucharest
country: Romania
facility: Institutul de Pneumoftiziologie "Marius Nasta"
city: Bucharest
country: Romania
facility: Novo Medica
city: Cluj
country: Romania
facility: Spitalul de Pneumoftiziologie "Leon Daniello"
city: Iasi
country: Romania
facility: Spitalul Clinic de Pneumoftiziologie
city: Targu Mures
country: Romania
facility: Clinica Pneumologie I, Spitalul Clinic Judetean Mureş
city: Timisoara
country: Romania
facility: Spitalul de Pneumoftiziologie "Victor Babes"
city: Bardejov
country: Slovakia
facility: Nemocnica s Poliklinicou "Svateho Jakuba"n.o.
city: Humenne
country: Slovakia
facility: Inspiro
city: Nitra
country: Slovakia
facility: Specializovana NemocnicaSvorada Zobor n.o.
city: Vysne Hagy
country: Slovakia
facility: Narodny Ustav Tuberculozy
city: Belfast
country: United Kingdom
facility: Regional Respiratory Centre, Belfast City Hospital
city: Hull
country: United Kingdom
facility: Cardiovascular and Respiratory Studies Department
city: Liverpool
country: United Kingdom
facility: Aintree Chest Centre, University Hospital Aintree
Study officials:
References:
citation: 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.