The Efficacy and Safety of Erdosteine in Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— RESTORE  

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01032304
• Other study ID #: ERD-01-08/EP
• Status: Unknown status
• Phase: Phase 3
• First received: December 11, 2009
• Last updated: June 12, 2014
• Start date: August 2009
• Est. completion date: September 2015

Study information

• Verified date: June 2014
• Source: Edmond Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 492
• Est. completion date: September 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Erdosteine
One 300 mg capsule twice a day
• Placebo
One capsule twice a day

Locations

Country	Name	City	State
Belgium	Campus Gasthuisberg Dep.t Longfunctiemetingen	Leuven
Bulgaria	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
Czech Republic	Plicnì Ordinace	Havlìckuv Brod
Czech Republic	Poliklinica Moravsky Krumlov	Moravsky Krumlov
Czech Republic	Department of Respiratory Medicine, Faculty Hospital	Olomouc
Czech Republic	Lerymed spol. s.r.o.	Praha
Czech Republic	Lipa Centrum Nove Butovice	Praha
Czech Republic	Plicnì M.I.O., spol. s.r.o.	Pribor
Czech Republic	Plicnì Ambulance	Prostejov
Czech Republic	Plicnì Ordinace	Strakonice
Czech Republic	Nemonice Znojmo	Znojmo
Denmark	Department of Respiratory Diseases, Copenhagen University Hospital	Hvidovre
France	Service de Pneumologie, Hopital Bichat	Paris
France	Service de Pneumologie, Hopital Bois-Guillaume	Rouen
Italy	Dip. Pneumologia Osp. G. Rummo	Benevento
Italy	U.O. Pneumologia	Bussolengo
Italy	UOC di Pneumologia- Ospedale Civile di Massa e Carrara	Carrara
Italy	UOC Pneumologia Riabilitativa INRCA	Casatenovo	Lecco
Italy	Ospedale Careggi, Malattie dell'Apparato Respiratorio	Firenze
Italy	UOC Pneumologia Osp. Vito Fazzi	Lecce
Italy	UOC di Pneumologia-Ospedale Mater Salutis	Legnago	Verona
Italy	U.O. Pneumologia	Macerata
Italy	Ospedale San Carlo Borromeo, Dipartimento Broncocardiopneumologico	Milano
Italy	UO di Pneumologia Osp. San Paolo	Milano
Poland	Szpital Uniwersytecki 2	Bydgoszczy
Poland	Klinika Pulmonologii II Katedry, Collegium Medicum Uniwersytetu	Krakow
Poland	Katedra Pulmunologii i Alergologii, Klinika Gruzlicy Uniwersytetu Medycznego	Lodz
Poland	Katedra i klinika Pulmonologii, Uniwersytet Medyczny	Poznan
Poland	NZOZ "Darmeticus"	Warsawa
Poland	Katedra i Klinika Pneumonologii, Warszawski Uniwersytet Medyczny	Warszawa
Romania	Institutul de Pneumoftiziologie "Marius Nasta"	Bucharest
Romania	Novo Medica	Bucharest
Romania	Spitalul de Pneumoftiziologie "Leon Daniello"	Cluj
Romania	Spitalul Clinic de Pneumoftiziologie	Iasi
Romania	Clinica Pneumologie I, Spitalul Clinic Judetean Mures	Targu Mures
Romania	Spitalul de Pneumoftiziologie "Victor Babes"	Timisoara
Slovakia	Nemocnica s Poliklinicou "Svateho Jakuba"n.o.	Bardejov
Slovakia	Inspiro	Humenne
Slovakia	Specializovana NemocnicaSvorada Zobor n.o.	Nitra
Slovakia	Narodny Ustav Tuberculozy	Vysne Hagy
United Kingdom	Regional Respiratory Centre, Belfast City Hospital	Belfast
United Kingdom	Cardiovascular and Respiratory Studies Department	Hull
United Kingdom	Aintree Chest Centre, University Hospital Aintree	Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
Edmond Pharma

Countries where clinical trial is conducted

Belgium,  Bulgaria,  Czech Republic,  Denmark,  France,  Italy,  Poland,  Romania,  Slovakia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of acute exacerbations		12 months
Secondary	spirometry parameters		12 months
Secondary	COPD symptoms		12 months
Secondary	Quality of life		12 months
Secondary	Safety and tolerability of erdosteine		12 months