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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Edmond Pharma
ClinicalTrials.gov Identifier:
NCT01032304
First received: December 11, 2009
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: Erdosteine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Edmond Pharma:

Primary Outcome Measures:
  • number of acute exacerbations [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • spirometry parameters [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • COPD symptoms [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Safety and tolerability of erdosteine [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 492
Study Start Date: August 2009
Estimated Study Completion Date: September 2015
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032304

  Show 46 Study Locations
Sponsors and Collaborators
Edmond Pharma
  More Information

No publications provided

Responsible Party: Edmond Pharma
ClinicalTrials.gov Identifier: NCT01032304     History of Changes
Other Study ID Numbers: ERD-01-08/EP
Study First Received: December 11, 2009
Last Updated: June 12, 2014
Health Authority: Italy: Ethics Committee
Denmark: Danish Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Czech Republic: State Institute for Drug Control
Poland: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Romania: National Medicines Agency

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Erdosteine
Expectorants
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014