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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erdosteine | Experimental | 600 mg/day for 12 months |
|
| Placebo | Placebo Comparator | Placebo for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erdosteine | Drug | One 300 mg capsule twice a day |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| number of acute exacerbations | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| spirometry parameters | 12 months | |
| COPD symptoms | 12 months | |
| Quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Campus Gasthuisberg Dep.t Longfunctiemetingen | Leuven | B-3000 | Belgium | |||
| ASMOH-MC "Sveti Panteleiomon" |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29025888 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 13, 2016 | |
| Reset | Nov 2, 2016 | |
| Release | Nov 21, 2016 |
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| Drug |
One capsule twice a day |
|
| 12 months |
| Safety and tolerability of erdosteine | 12 months |
| Sofia |
| 1463 |
| 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 | Bulgaria |
| Plicnì Ordinace | Havlìckuv Brod | Czechia |
| Poliklinica Moravsky Krumlov | Moravský Krumlov | Czechia |
| Department of Respiratory Medicine, Faculty Hospital | Olomouc | Czechia |
| Lipa Centrum Nove Butovice | Prague | 15900 | Czechia |
| Lerymed spol. s.r.o. | Prague | Czechia |
| Plicnì Ambulance | Prostějov | 79601 | Czechia |
| Plicnì M.I.O., spol. s.r.o. | Příbor | Czechia |
| Plicnì Ordinace | Strakonice | 38601 | Czechia |
| Nemonice Znojmo | Znojmo | 66902 | Czechia |
| Department of Respiratory Diseases, Copenhagen University Hospital | Hvidovre | Denmark |
| Service de Pneumologie, Hopital Bichat | Paris | France |
| Service de Pneumologie, Hopital Bois-Guillaume | Rouen | France |
| UOC Pneumologia Riabilitativa INRCA | Casatenovo | Lecco | Italy |
| UOC di Pneumologia-Ospedale Mater Salutis | Legnago | Verona | Italy |
| Dip. Pneumologia Osp. G. Rummo | Benevento | Italy |
| U.O. Pneumologia | Bussolengo | Italy |
| UOC di Pneumologia- Ospedale Civile di Massa e Carrara | Carrara | Italy |
| Ospedale Careggi, Malattie dell'Apparato Respiratorio | Florence | Italy |
| UOC Pneumologia Osp. Vito Fazzi | Lecce | Italy |
| UO di Pneumologia Osp. San Paolo | Milan | 20100 | Italy |
| Ospedale San Carlo Borromeo, Dipartimento Broncocardiopneumologico | Milan | Italy |
| U.O. Pneumologia | Province of Macerata | Italy |
| Szpital Uniwersytecki 2 | Bydgoszczy | 85168 | Poland |
| Klinika Pulmonologii II Katedry, Collegium Medicum Uniwersytetu | Krakow | Poland |
| Katedra Pulmunologii i Alergologii, Klinika Gruźlicy Uniwersytetu Medycznego | Lodz | Poland |
| Katedra i klinika Pulmonologii, Uniwersytet Medyczny | Poznan | Poland |
| NZOZ "Darmeticus" | Warsaw | 04364 | Poland |
| Katedra i Klinika Pneumonologii, Warszawski Uniwersytet Medyczny | Warsaw | Poland |
| Institutul de Pneumoftiziologie "Marius Nasta" | Bucharest | Romania |
| Novo Medica | Bucharest | Romania |
| Spitalul de Pneumoftiziologie "Leon Daniello" | Cluj-Napoca | Romania |
| Spitalul Clinic de Pneumoftiziologie | Iași | Romania |
| Clinica Pneumologie I, Spitalul Clinic Judetean Mureş | Târgu Mureş | Romania |
| Spitalul de Pneumoftiziologie "Victor Babes" | Timișoara | Romania |
| Nemocnica s Poliklinicou "Svateho Jakuba"n.o. | Bardejov | 08501 | Slovakia |
| Inspiro | Humenné | 06601 | Slovakia |
| Specializovana NemocnicaSvorada Zobor n.o. | Nitra | 94901 | Slovakia |
| Narodny Ustav Tuberculozy | Vyšné Hágy | 05984 | Slovakia |
| Regional Respiratory Centre, Belfast City Hospital | Belfast | United Kingdom |
| Cardiovascular and Respiratory Studies Department | Hull | United Kingdom |
| Aintree Chest Centre, University Hospital Aintree | Liverpool | United Kingdom |
| Unrelease | Yes |
| Release | Jan 10, 2017 |
| Reset | Feb 28, 2017 |
| Release | May 12, 2017 |
| Unrelease | Yes |
| Release | May 17, 2017 |
| Reset | Dec 18, 2017 |
| Release | Feb 6, 2018 |
| Reset | Feb 7, 2018 |
| Release | Feb 9, 2018 |
| Reset | Oct 26, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 13, 2016 | Nov 2, 2016 | |||
| Nov 21, 2016 | Yes | |||
| Jan 10, 2017 | Feb 28, 2017 | |||
| May 12, 2017 | Yes | |||
| May 17, 2017 | Dec 18, 2017 | |||
| Feb 6, 2018 | Feb 7, 2018 | |||
| Feb 9, 2018 | Oct 26, 2018 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C048498 | erdosteine |
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