Erdosteine (Erdotin) Versus Standard Care Plus Placebo on Erdosteine for Treatment of Cough in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT01176318
- Lead Sponsor
- Hull University Teaching Hospitals NHS Trust
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo Placebo Standard care for exacerbation of COPD plus placebo erdosteine Erdosteine standard care plus erdosteine for 10 days
- Primary Outcome Measures
Name Time Method 24 hr cough recording 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
Name Time Method Quality of life questionnaire 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.
Trial Locations
- Locations (1)
Castle Hill Hospital
🇬🇧Cottingham, East Yorkshire, United Kingdom