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

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)

Sponsors

Lead Sponsor: Hull University Teaching Hospitals NHS Trust

Collaborator: Galen Limited

Source 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.

Overall Status Withdrawn
Start Date August 10, 2010
Completion Date January 13, 2012
Primary Completion Date October 12, 2011
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
24 hr cough recording 5 days
Secondary Outcome
Measure Time Frame
Quality of life questionnaire 10 days
Condition
Intervention

Intervention Type: Drug

Intervention Name: Erdosteine

Description: capsule 300mg twice daily for 10 days

Arm Group Label: erdosteine

Other Name: erdotin

Intervention Type: Drug

Intervention Name: Placebo

Description: placebo capsule, twice daily for 10 days

Arm Group Label: placebo

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

Gender: All

Minimum Age: 40 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Alyn H Morice, FRCP Principal Investigator Hull and east Yorkshire NHS trust
Location
Facility: Castle Hill Hospital
Location Countries

United Kingdom

Verification Date

June 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: erdosteine

Type: Experimental

Description: standard care plus erdosteine for 10 days

Label: placebo

Type: Placebo Comparator

Description: Standard care for exacerbation of COPD plus placebo

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov