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

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• Status: Withdrawn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: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Erdosteine; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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

• 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

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: quality of life; exacerbation; cough
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory System Agents; Expectorants; Erdosteine
• Other Study ID Numbers: Erd090908