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)

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01176318

Enrollment

Registered

2010-08-06

Start date

2010-08-10

Completion date

2012-01-13

Last updated

2019-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

cough, exacerbation, quality of life

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.

Interventions

DRUGErdosteine

capsule 300mg twice daily for 10 days

DRUGPlacebo

placebo capsule, twice daily for 10 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
24 hr cough recording	5 days	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

Measure	Time frame	Description
Quality of life questionnaire	10 days	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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026