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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Erdosteine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: erdosteine<br>standard care plus erdosteine for 10 days | Drug: Erdosteine<br>* capsule 300mg twice daily for 10 days<br>* Other names: erdotin;|
| Placebo Comparator: placebo<br>Standard care for exacerbation of COPD plus placebo | Drug: Placebo<br>* placebo capsule, twice daily for 10 days<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cough, exacerbation, quality of life