Back to resultsErdosteine (Erdotin) Versus Standard Care Plus Placebo on Erdosteine for Treatment of Cough in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Withdrawn
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Erdosteine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring cough, exacerbation, quality of life
Eligibility Criteria
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
Sites / Locations
- Castle Hill Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
erdosteine
placebo
Arm Description
standard care plus erdosteine for 10 days
Standard care for exacerbation of COPD plus placebo
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01176318
First Posted
August 4, 2010
Last Updated
June 17, 2019
Sponsor
Hull University Teaching Hospitals NHS Trust
Collaborators
Galen Limited
1. Study Identification
Unique Protocol Identification Number
NCT01176318
Brief Title
Erdosteine (Erdotin) Versus Standard Care Plus Placebo on Erdosteine for Treatment of Cough in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Withdrawn
Why Stopped
grant was withdrawn no financial support to conduct the study.
Study Start Date
August 10, 2010 (Anticipated)
Primary Completion Date
October 12, 2011 (Anticipated)
Study Completion Date
January 13, 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hull University Teaching Hospitals NHS Trust
Collaborators
Galen Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
cough, exacerbation, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
erdosteine
Arm Type
Experimental
Arm Description
standard care plus erdosteine for 10 days
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Standard care for exacerbation of COPD plus placebo
Intervention Type
Drug
Intervention Name(s)
Erdosteine
Other Intervention Name(s)
erdotin
Intervention Description
capsule 300mg twice daily for 10 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo capsule, twice daily for 10 days
Primary Outcome Measure Information:
Title
24 hr cough recording
Description
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
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Quality of life questionnaire
Description
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.
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alyn H Morice, FRCP
Organizational Affiliation
Hull and east Yorkshire NHS trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Castle Hill Hospital
City
Cottingham
State/Province
East Yorkshire
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Erdosteine (Erdotin) Versus Standard Care Plus Placebo on Erdosteine for Treatment of Cough in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
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