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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01032304
Recruitment Status : Unknown
Verified June 2014 by Edmond Pharma.
Recruitment status was:  Active, not recruiting
First Posted : December 15, 2009
Last Update Posted : June 13, 2014
Information provided by (Responsible Party):
Edmond Pharma

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: Erdosteine Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 492 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2009
Actual Primary Completion Date : March 2014
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: Erdosteine
600 mg/day for 12 months
Drug: Erdosteine
One 300 mg capsule twice a day

Placebo Comparator: Placebo
Placebo for 12 months
Drug: Placebo
One capsule twice a day

Primary Outcome Measures :
  1. number of acute exacerbations [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. spirometry parameters [ Time Frame: 12 months ]
  2. COPD symptoms [ Time Frame: 12 months ]
  3. Quality of life [ Time Frame: 12 months ]
  4. Safety and tolerability of erdosteine [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01032304

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Sponsors and Collaborators
Edmond Pharma
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Edmond Pharma Identifier: NCT01032304    
Other Study ID Numbers: ERD-01-08/EP
First Posted: December 15, 2009    Key Record Dates
Last Update Posted: June 13, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Respiratory System Agents