Chronic Obstructive Pulmonary Disease (COPD)Phase 3RESTORENCT01032304
The Efficacy and Safety of Erdosteine in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing Erdosteine in people with Chronic Obstructive Pulmonary Disease (COPD), run by Edmond Pharma at 46 sites in 10 countries.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Erdosteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 492 participants
- Where
- 46 sitesin 10 countries
- Study dates
- Aug 2009to Sep 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD stage II-III GOLD
- At least 2 exacerbations in the previous 2-12 months
Who cannot join
- Acute exacerbations in the 2 months prior to enrolment
- Diagnosis of asthma and/or other relevant lung diseases
- COPD stage IV
- Unstable concurrent diseases
Trial locations and contacts
46 sites in 10 countries.
46 sites in 10 countries
Italy10 sites
Dip. Pneumologia Osp. G. Rummo
Benevento
U.O. Pneumologia
Bussolengo
UOC di Pneumologia- Ospedale Civile di Massa e Carrara
Carrara
UOC Pneumologia Riabilitativa INRCA
Casatenovo, Lecco
Ospedale Careggi, Malattie dell'Apparato Respiratorio
Florence
UOC Pneumologia Osp. Vito Fazzi
Lecce
UOC di Pneumologia-Ospedale Mater Salutis
Legnago, Verona
UO di Pneumologia Osp. San Paolo
Milan, 20100
Ospedale San Carlo Borromeo, Dipartimento Broncocardiopneumologico
Milan
U.O. Pneumologia
Province of Macerata
Czechia9 sites
Plicnì Ordinace
Havlìckuv Brod
Poliklinica Moravsky Krumlov
Moravský Krumlov
Department of Respiratory Medicine, Faculty Hospital
Olomouc
Lipa Centrum Nove Butovice
Prague, 15900
Lerymed spol. s.r.o.
Prague
Plicnì M.I.O., spol. s.r.o.
Příbor
Plicnì Ambulance
Prostějov, 79601
Plicnì Ordinace
Strakonice, 38601
Nemonice Znojmo
Znojmo, 66902
Poland6 sites
Szpital Uniwersytecki 2
Bydgoszczy, 85168
Klinika Pulmonologii II Katedry, Collegium Medicum Uniwersytetu
Krakow
Katedra Pulmunologii i Alergologii, Klinika Gruźlicy Uniwersytetu Medycznego
Lodz
Katedra i klinika Pulmonologii, Uniwersytet Medyczny
Poznan
NZOZ "Darmeticus"
Warsaw, 04364
Katedra i Klinika Pneumonologii, Warszawski Uniwersytet Medyczny
Warsaw
Romania6 sites
Institutul de Pneumoftiziologie "Marius Nasta"
Bucharest
Novo Medica
Bucharest
Spitalul de Pneumoftiziologie "Leon Daniello"
Cluj-Napoca
Spitalul Clinic de Pneumoftiziologie
Iași
Clinica Pneumologie I, Spitalul Clinic Judetean Mureş
Târgu Mureş
Spitalul de Pneumoftiziologie "Victor Babes"
Timișoara
Bulgaria4 sites
ASMOH-MC "Sveti Panteleiomon"
Sofia, 1463
Clinic for emergency Medicine and Intensive care, Pneumology and Physiatry
Sofia
Clinic of Pulmonary Disease-Military Medical Academy
Sofia
Clinical of Pneumology and Physiatry
Varna
Slovakia4 sites
Nemocnica s Poliklinicou "Svateho Jakuba"n.o.
Bardejov, 08501
Inspiro
Humenné, 06601
Specializovana NemocnicaSvorada Zobor n.o.
Nitra, 94901
Narodny Ustav Tuberculozy
Vyšné Hágy, 05984
United Kingdom3 sites
Regional Respiratory Centre, Belfast City Hospital
Belfast
Cardiovascular and Respiratory Studies Department
Hull
Aintree Chest Centre, University Hospital Aintree
Liverpool
France2 sites
Service de Pneumologie, Hopital Bichat
Paris
Service de Pneumologie, Hopital Bois-Guillaume
Rouen
Denmark1 site
Department of Respiratory Diseases, Copenhagen University Hospital
Hvidovre
About this study
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
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.
- Being tested
- Erdosteine, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErdosteineDrug
One 300 mg capsule twice a day
PlaceboDrug
One capsule twice a day
| Study group | Role | What they receive |
|---|---|---|
| Erdosteine | Experimental | 600 mg/day for 12 months Receives: Drug: Erdosteine |
| Placebo | Placebo comparator | Placebo for 12 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of acute exacerbations
Measured: 12 months
Secondary outcomes (4)
spirometry parameters
Measured: 12 months
COPD symptoms
Measured: 12 months
Quality of life
Measured: 12 months
Safety and tolerability of erdosteine
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startAug 2009
- Primary completionMar 2014
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 492 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edmond Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032304
- Sponsor's protocol ID
- ERD-01-08/EP
- Acronym
- RESTORE
- Status last verified
- Jun 2014
- First submitted
- 11 Dec 2009
- Last updated
- 13 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29025888
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01032304
- Acronym / sponsor ID
- RESTORE / ERD-01-08/EP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 492 participants (estimated)
- Lead sponsor
- Edmond PharmaIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Sep 2015 (estimated)
- First posted
- 15 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erdosteine | Experimental | Drug: Erdosteine600 mg/day for 12 months |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo for 12 months |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- COPD stage II-III GOLD
- At least 2 exacerbations in the previous 2-12 months
Key exclusion criteria (4 listed)
- Acute exacerbations in the 2 months prior to enrolment
- Diagnosis of asthma and/or other relevant lung diseases
- COPD stage IV
- Unstable concurrent diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErdosteineOne 300 mg capsule twice a day | Drug | Erdosteine |
| PlaceboOne capsule twice a day | Drug | Placebo |
Primary outcome
number of acute exacerbations
Time frame: 12 months
4 secondary outcomes
spirometry parameters
Time frame: 12 months
COPD symptoms
Time frame: 12 months
Quality of life
Time frame: 12 months
Safety and tolerability of erdosteine
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2014.
- Derived from this study: PubMed 29025888Dal 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.
Related trials for Chronic Obstructive Pulmonary Disease (COPD)
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
46 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Erdosteine in people with Chronic Obstructive Pulmonary Disease (COPD), run by Edmond Pharma at 46 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in Italy, Czechia, Poland, Romania, Bulgaria and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of acute exacerbations (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01032304, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2014.