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Erdosteine (Erdotin) Versus Standard Care Plus Placebo on Erdosteine for Treatment of Cough in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)

This study has been withdrawn prior to enrollment.
(pharmaceutical grant was withdrawn, thus no financial support to conduct the study.)
Sponsor:
Collaborator:
Galen limited
Information provided by:
Hull and East Yorkshire Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01176318
First received: August 4, 2010
Last updated: January 9, 2012
Last verified: July 2010
History of Changes
  Purpose

This is a parallel group, double-blind, placebo controlled, multi-centre, randomised trial.

60 patients to be included who are adult patients admitted to hospital with a clinical diagnosis of acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). Acute exacerbation of COPD will be defined as sustained worsening of the patient's condition with an increase in cough and one or more of dyspnoea, sputum volume or sputum purulence, necessitating a change in regular medication.

The primary objective of this study is to evaluate the effectiveness of standard care plus erdosteine in reducing hourly cough (24 hour cough recording using automated cough recorder) measured from baseline (Day 0) and at Day 5 of treatment, compared with standard care plus placebo.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
 Drug: Erdosteine
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind, Placebo Controlled Multicentre Study of the Effects of Standard Care Plus Erdosteine (Erdotin) Versus Standard Care Plus Placebo on Cough in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hull and East Yorkshire Hospitals NHS Trust:

Primary Outcome Measures:
  • 24 hr cough recording [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    The primary objective is to evaluate the effectiveness of standard care plus erdosteine in reducing hourly cough (24 hour cough recording using automated cough recorder) measureing differerrence in hourly cough rate from baseline (Day 0) and Day 5 of treatment, compared with standard care plus placebo


Secondary Outcome Measures:
  • Quality of life questionnaire [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    QOL questionnaire score,Compare differece in scores recorded at baseline (day 0) and day 10, compare the difference between erdosteine plus standard care with that of standard care plus placebo.


Enrollment: 0
Arms Assigned Interventions
Experimental: erdosteine
standard care plus erdosteine for 10 days
 Drug: Erdosteine
capsule 300mg twice daily for 10 days
Other Name: erdotin
Placebo Comparator: placebo
Standard care for exacerbation of COPD plus placebo
 Drug: Placebo
placebo capsule, twice daily for 10 days

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male/females aged between 40-80 years
  • Previous diagnosis of COPD
  • Acute exacerbation of COPD requiring treatment with antibiotics and/or corticosteroids
  • Symptoms of increased breathlessness, cough, sputum volume or sputum purulence
  • Acute exacerbation of COPD hospitalised within 24hrs of study participation.
  • On a stable therapeutic regimen for COPD for 8 weeks prior to inclusion
  • Known history of cigarette smoking at least 10 pack yrs
  • Willing and able to comply with study procedures
  • Able to provide written informed consent to participate

Exclusion Criteria:

  • Acute exacerbation of COPD within 8 weeks prior to inclusion
  • Arterial blood gas on admission < pH 7.26
  • Currently on treatment with mucolytics
  • Patients suffering from post nasal drip, or gastro-oesophageal reflux disease
  • Clinically significant or unstable concurrent disease e.g. left ventricular failure, diabetes mellitus
  • On long-term oxygen therapy
  • Known or suspected hypersensitivity to erdosteine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01176318

Locations
United Kingdom
Castle Hill Hospital
Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
Sponsors and Collaborators
Hull and East Yorkshire Hospitals NHS Trust
Galen limited
Investigators
Principal Investigator: Alyn H Morice, FRCP Hull and east Yorkshire NHS trust
  More Information

No publications provided

Responsible Party: Professor Alyn Morice, Hull and East orkshire HospitalsTrust
ClinicalTrials.gov Identifier: NCT01176318     History of Changes
Other Study ID Numbers: Erd090908
Study First Received: August 4, 2010
Last Updated: January 9, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Hull and East Yorkshire Hospitals NHS Trust:
cough
exacerbation
quality of life

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 May 23, 2013