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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2014 by Edmond Pharma.
Recruitment status was:  Active, not recruiting
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
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 ]

Secondary Outcome Measures:
  • 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 ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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

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

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Erdosteine
Expectorants
Respiratory System Agents

ClinicalTrials.gov processed this record on February 24, 2017