NCT01032304: RESTORE

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

Status unknown Phase 3 Last updated 12 June 2014

What this trial tests

Phase 3 trial testing Erdosteine in Chronic Obstructive Pulmonary Disease (COPD) in 492 participants. Status unknown.

Timeline

1 August 2009

Primary endpoint
1 March 2014

1 September 2015

Quick facts

Lead sponsor	Edmond Pharma
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	492
Start date	1 August 2009
Primary completion	1 March 2014
Estimated completion	1 September 2015
Sites	46 locations across Belgium, Bulgaria, Czechia, Denmark, France, Italy, Poland, Romania

Drugs / interventions tested

• Erdosteine (ERDOSTEINE) — full drug profile →
• Placebo

Conditions studied

• Chronic Obstructive Pulmonary Disease (COPD) — all drugs for Chronic Obstructive Pulmonary Disease (COPD) →

Sponsor

Edmond Pharma

Who can join

Adults 40 to 80, any sex, with Chronic Obstructive Pulmonary Disease (COPD). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• number of acute exacerbations
  Time frame: 12 months

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Redox regulation: mechanisms, biology and therapeutic targets in diseases.
   Li B, Ming H, Qin S, Nice EC, et al · · 2025 · cited 104× · PMID 40050273 · DOI 10.1038/s41392-024-02095-6
2. Effect of erdosteine on the rate and duration of COPD exacerbations: the RESTORE study.
   Dal Negro RW, Wedzicha JA, Iversen M, Fontana G, et al · · 2017 · cited 54× · PMID 29025888 · DOI 10.1183/13993003.00711-2017
3. Efficacy and safety profile of mucolytic/antioxidant agents in chronic obstructive pulmonary disease: a comparative analysis across erdosteine, carbocysteine, and N-acetylcysteine.
   Rogliani P, Matera MG, Page C, Puxeddu E, et al · · 2019 · cited 47× · PMID 31133026 · DOI 10.1186/s12931-019-1078-y
4. Effect of Erdosteine on COPD Exacerbations in COPD Patients with Moderate Airflow Limitation.
   Calverley PM, Page C, Dal Negro RW, Fontana G, et al · · 2019 · cited 21× · PMID 31819405 · DOI 10.2147/copd.s221852
5. Multifaceted Beneficial Effects of Erdosteine: More than a Mucolytic Agent.
   Cazzola M, Page C, Rogliani P, Calzetta L, et al · · 2020 · cited 19× · PMID 33025535 · DOI 10.1007/s40265-020-01412-x
6. The Effect of Maintenance Treatment with Erdosteine on Exacerbation Treatment and Health Status in Patients with COPD: A Post-Hoc Analysis of the RESTORE Dataset.
   Calverley PMA, Papi A, Page C, Rogliani P, et al · · 2022 · cited 7× · PMID 36034589 · DOI 10.2147/copd.s369804