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

E

Edmond Pharma

Status and phase

Unknown
Phase 3

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Treatments

Drug: Erdosteine
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01032304
ERD-01-08/EP

Details and patient eligibility

About

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.

Enrollment

492 estimated patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

492 participants in 2 patient groups, including a placebo group

Erdosteine
Experimental group
Description:
600 mg/day for 12 months
Treatment:
Drug: Erdosteine
Placebo
Placebo Comparator group
Description:
Placebo for 12 months
Treatment:
Drug: Placebo

Trial contacts and locations

46

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Data sourced from clinicaltrials.gov

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