Overview

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

Status:
Withdrawn

Trial end date:
2012-01-13

Target enrollment:

Participant gender:

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.

Phase:

Phase 4

Details

Lead Sponsor:

Hull and East Yorkshire Hospitals NHS Trust
Hull University Teaching Hospitals NHS Trust

Collaborator:

Galen Limited

Treatments:

Erdosteine