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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This study has been withdrawn prior to enrollment.
(pharmaceutical grant was withdrawn, thus no financial support to conduct the study.)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:
ClinicalTrials.gov Identifier:
NCT01176318
First Posted: August 6, 2010
Last Update Posted: January 10, 2012
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.
Collaborator:
Galen Limited
Information provided by:
Hull and East Yorkshire Hospitals NHS Trust
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


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

Primary Outcome Measures:
  • 24 hr cough recording [ Time Frame: 5 days ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Professor Alyn Morice, Hull and East orkshire HospitalsTrust
ClinicalTrials.gov Identifier: NCT01176318     History of Changes
Other Study ID Numbers: Erd090908
First Submitted: August 4, 2010
First Posted: August 6, 2010
Last Update Posted: January 10, 2012
Last Verified: July 2010

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

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