Status:
WITHDRAWN
Erdosteine (Erdotin) Versus Standard Care Plus Placebo on Erdosteine for Treatment of Cough in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Hull University Teaching Hospitals NHS Trust
Collaborating Sponsors:
Galen Limited
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-80 years
Phase:
PHASE4
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 e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 10 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01176318
Start Date
August 10 2010
End Date
January 13 2012
Last Update
June 19 2019
Active Locations (1)
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1
Castle Hill Hospital
Cottingham, East Yorkshire, United Kingdom, HU16 5JQ