Erdosteine (Erdotin) Versus Standard Care Plus Placebo on Erdosteine for Treatment of Cough in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT01176318
Last Updated: 2019-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2010-08-10
2012-01-13
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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erdosteine
standard care plus erdosteine for 10 days
Erdosteine
capsule 300mg twice daily for 10 days
placebo
Standard care for exacerbation of COPD plus placebo
Placebo
placebo capsule, twice daily for 10 days
Interventions
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Erdosteine
capsule 300mg twice daily for 10 days
Placebo
placebo capsule, twice daily for 10 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
80 Years
ALL
No
Sponsors
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Galen Limited
INDUSTRY
Hull University Teaching Hospitals NHS Trust
OTHER_GOV
Responsible Party
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Principal Investigators
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Alyn H Morice, FRCP
Role: PRINCIPAL_INVESTIGATOR
Hull and east Yorkshire NHS trust
Locations
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Castle Hill Hospital
Cottingham, East Yorkshire, United Kingdom
Countries
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Other Identifiers
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Erd090908
Identifier Type: -
Identifier Source: org_study_id
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