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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01176318
• Other study ID #: Erd090908
• Status: Withdrawn
• Phase: Phase 4
• Start date: August 10, 2010
• Est. completion date: January 13, 2012

Study information

• Verified date: June 2019
• Source: Hull and East Yorkshire Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 13, 2012
• Est. primary completion date: October 12, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Erdosteine
capsule 300mg twice daily for 10 days
• Placebo
placebo capsule, twice daily for 10 days

Locations

Country	Name	City	State
United Kingdom	Castle Hill Hospital	Cottingham	East Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Hull and East Yorkshire Hospitals NHS Trust	Galen Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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