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

June 17, 2019 updated by: Hull University Teaching Hospitals NHS Trust

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)

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • East Yorkshire
      • Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
        • Castle Hill Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: erdosteine
standard care plus erdosteine for 10 days
Drug: Erdosteine
capsule 300mg twice daily for 10 days
Other Names:
  • erdotin
Placebo Comparator: placebo
Standard care for exacerbation of COPD plus placebo
Drug: Placebo
placebo capsule, twice daily for 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hull University Teaching Hospitals NHS Trust

Collaborators

Galen Limited

Investigators

  • Principal Investigator: Alyn H Morice, FRCP, Hull and East Yorkshire NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 10, 2010

Primary Completion (Anticipated)

October 12, 2011

Study Completion (Anticipated)

January 13, 2012

Study Registration Dates

First Submitted

August 4, 2010

First Submitted That Met QC Criteria

August 5, 2010

First Posted (Estimate)

August 6, 2010

Study Record Updates

Last Update Posted (Actual)

June 19, 2019

Last Update Submitted That Met QC Criteria

June 17, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Erd090908

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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