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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Erdosteine
Placebo
Sponsored by
Edmond Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Campus Gasthuisberg Dep.t Longfunctiemetingen
  • ASMOH-MC "Sveti Panteleiomon"
  • Clinic for emergency Medicine and Intensive care, Pneumology and Physiatry
  • Clinic of Pulmonary Disease-Military Medical Academy
  • Clinical of Pneumology and Physiatry
  • Plicnì Ordinace
  • Poliklinica Moravsky Krumlov
  • Department of Respiratory Medicine, Faculty Hospital
  • Lipa Centrum Nove Butovice
  • Lerymed spol. s.r.o.
  • Plicnì M.I.O., spol. s.r.o.
  • Plicnì Ambulance
  • Plicnì Ordinace
  • Nemonice Znojmo
  • Department of Respiratory Diseases, Copenhagen University Hospital
  • Service de Pneumologie, Hopital Bichat
  • Service de Pneumologie, Hopital Bois-Guillaume
  • UOC Pneumologia Riabilitativa INRCA
  • UOC di Pneumologia-Ospedale Mater Salutis
  • Dip. Pneumologia Osp. G. Rummo
  • U.O. Pneumologia
  • UOC di Pneumologia- Ospedale Civile di Massa e Carrara
  • Ospedale Careggi, Malattie dell'Apparato Respiratorio
  • UOC Pneumologia Osp. Vito Fazzi
  • U.O. Pneumologia
  • UO di Pneumologia Osp. San Paolo
  • Ospedale San Carlo Borromeo, Dipartimento Broncocardiopneumologico
  • Szpital Uniwersytecki 2
  • Klinika Pulmonologii II Katedry, Collegium Medicum Uniwersytetu
  • Katedra Pulmunologii i Alergologii, Klinika Gruźlicy Uniwersytetu Medycznego
  • Katedra i klinika Pulmonologii, Uniwersytet Medyczny
  • NZOZ "Darmeticus"
  • Katedra i Klinika Pneumonologii, Warszawski Uniwersytet Medyczny
  • Institutul de Pneumoftiziologie "Marius Nasta"
  • Novo Medica
  • Spitalul de Pneumoftiziologie "Leon Daniello"
  • Spitalul Clinic de Pneumoftiziologie
  • Clinica Pneumologie I, Spitalul Clinic Judetean Mureş
  • Spitalul de Pneumoftiziologie "Victor Babes"
  • Nemocnica s Poliklinicou "Svateho Jakuba"n.o.
  • Inspiro
  • Specializovana NemocnicaSvorada Zobor n.o.
  • Narodny Ustav Tuberculozy
  • Regional Respiratory Centre, Belfast City Hospital
  • Cardiovascular and Respiratory Studies Department
  • Aintree Chest Centre, University Hospital Aintree

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Erdosteine

Placebo

Arm Description

600 mg/day for 12 months

Placebo for 12 months

Outcomes

Primary Outcome Measures

number of acute exacerbations

Secondary Outcome Measures

spirometry parameters
COPD symptoms
Quality of life
Safety and tolerability of erdosteine

Full Information

First Posted
December 11, 2009
Last Updated
June 12, 2014
Sponsor
Edmond Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01032304
Brief Title
The Efficacy and Safety of Erdosteine in Chronic Obstructive Pulmonary Disease (COPD)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edmond Pharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
492 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Erdosteine
Arm Type
Experimental
Arm Description
600 mg/day for 12 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for 12 months
Intervention Type
Drug
Intervention Name(s)
Erdosteine
Intervention Description
One 300 mg capsule twice a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One capsule twice a day
Primary Outcome Measure Information:
Title
number of acute exacerbations
Time Frame
12 months
Secondary Outcome Measure Information:
Title
spirometry parameters
Time Frame
12 months
Title
COPD symptoms
Time Frame
12 months
Title
Quality of life
Time Frame
12 months
Title
Safety and tolerability of erdosteine
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Campus Gasthuisberg Dep.t Longfunctiemetingen
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
ASMOH-MC "Sveti Panteleiomon"
City
Sofia
ZIP/Postal Code
1463
Country
Bulgaria
Facility Name
Clinic for emergency Medicine and Intensive care, Pneumology and Physiatry
City
Sofia
Country
Bulgaria
Facility Name
Clinic of Pulmonary Disease-Military Medical Academy
City
Sofia
Country
Bulgaria
Facility Name
Clinical of Pneumology and Physiatry
City
Varna
Country
Bulgaria
Facility Name
Plicnì Ordinace
City
Havlìckuv Brod
Country
Czech Republic
Facility Name
Poliklinica Moravsky Krumlov
City
Moravsky Krumlov
Country
Czech Republic
Facility Name
Department of Respiratory Medicine, Faculty Hospital
City
Olomouc
Country
Czech Republic
Facility Name
Lipa Centrum Nove Butovice
City
Praha
ZIP/Postal Code
15900
Country
Czech Republic
Facility Name
Lerymed spol. s.r.o.
City
Praha
Country
Czech Republic
Facility Name
Plicnì M.I.O., spol. s.r.o.
City
Pribor
Country
Czech Republic
Facility Name
Plicnì Ambulance
City
Prostejov
ZIP/Postal Code
79601
Country
Czech Republic
Facility Name
Plicnì Ordinace
City
Strakonice
ZIP/Postal Code
38601
Country
Czech Republic
Facility Name
Nemonice Znojmo
City
Znojmo
ZIP/Postal Code
66902
Country
Czech Republic
Facility Name
Department of Respiratory Diseases, Copenhagen University Hospital
City
Hvidovre
Country
Denmark
Facility Name
Service de Pneumologie, Hopital Bichat
City
Paris
Country
France
Facility Name
Service de Pneumologie, Hopital Bois-Guillaume
City
Rouen
Country
France
Facility Name
UOC Pneumologia Riabilitativa INRCA
City
Casatenovo
State/Province
Lecco
Country
Italy
Facility Name
UOC di Pneumologia-Ospedale Mater Salutis
City
Legnago
State/Province
Verona
Country
Italy
Facility Name
Dip. Pneumologia Osp. G. Rummo
City
Benevento
Country
Italy
Facility Name
U.O. Pneumologia
City
Bussolengo
Country
Italy
Facility Name
UOC di Pneumologia- Ospedale Civile di Massa e Carrara
City
Carrara
Country
Italy
Facility Name
Ospedale Careggi, Malattie dell'Apparato Respiratorio
City
Firenze
Country
Italy
Facility Name
UOC Pneumologia Osp. Vito Fazzi
City
Lecce
Country
Italy
Facility Name
U.O. Pneumologia
City
Macerata
Country
Italy
Facility Name
UO di Pneumologia Osp. San Paolo
City
Milano
ZIP/Postal Code
20100
Country
Italy
Facility Name
Ospedale San Carlo Borromeo, Dipartimento Broncocardiopneumologico
City
Milano
Country
Italy
Facility Name
Szpital Uniwersytecki 2
City
Bydgoszczy
ZIP/Postal Code
85168
Country
Poland
Facility Name
Klinika Pulmonologii II Katedry, Collegium Medicum Uniwersytetu
City
Krakow
Country
Poland
Facility Name
Katedra Pulmunologii i Alergologii, Klinika Gruźlicy Uniwersytetu Medycznego
City
Lodz
Country
Poland
Facility Name
Katedra i klinika Pulmonologii, Uniwersytet Medyczny
City
Poznan
Country
Poland
Facility Name
NZOZ "Darmeticus"
City
Warsawa
ZIP/Postal Code
04364
Country
Poland
Facility Name
Katedra i Klinika Pneumonologii, Warszawski Uniwersytet Medyczny
City
Warszawa
Country
Poland
Facility Name
Institutul de Pneumoftiziologie "Marius Nasta"
City
Bucharest
Country
Romania
Facility Name
Novo Medica
City
Bucharest
Country
Romania
Facility Name
Spitalul de Pneumoftiziologie "Leon Daniello"
City
Cluj
Country
Romania
Facility Name
Spitalul Clinic de Pneumoftiziologie
City
Iasi
Country
Romania
Facility Name
Clinica Pneumologie I, Spitalul Clinic Judetean Mureş
City
Targu Mures
Country
Romania
Facility Name
Spitalul de Pneumoftiziologie "Victor Babes"
City
Timisoara
Country
Romania
Facility Name
Nemocnica s Poliklinicou "Svateho Jakuba"n.o.
City
Bardejov
ZIP/Postal Code
08501
Country
Slovakia
Facility Name
Inspiro
City
Humenne
ZIP/Postal Code
06601
Country
Slovakia
Facility Name
Specializovana NemocnicaSvorada Zobor n.o.
City
Nitra
ZIP/Postal Code
94901
Country
Slovakia
Facility Name
Narodny Ustav Tuberculozy
City
Vysne Hagy
ZIP/Postal Code
05984
Country
Slovakia
Facility Name
Regional Respiratory Centre, Belfast City Hospital
City
Belfast
Country
United Kingdom
Facility Name
Cardiovascular and Respiratory Studies Department
City
Hull
Country
United Kingdom
Facility Name
Aintree Chest Centre, University Hospital Aintree
City
Liverpool
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29025888
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.
Results Reference
derived

Learn more about this trial

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

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