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

NHS Trust

Status and phase: Withdrawn; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Placebo; Drug: Erdosteine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01176318

Erd090908

Details and patient eligibility

About

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.

Sex: All

Ages: 40 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

erdosteine

Experimental group

Description:

standard care plus erdosteine for 10 days

Treatment:

Drug: Erdosteine

placebo

Placebo Comparator group

Description:

Standard care for exacerbation of COPD plus placebo

Treatment:

Drug: Placebo