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

NCT01176318 | Withdrawn Phase 4

• 1 other identifier: Erd090908
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

cough; exacerbation; quality of life

Outcome Measures

Primary Outcomes (1)

• 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

  5 days

Secondary Outcomes (1)

• Quality of life questionnaire

  10 days

Study Arms (2)

erdosteine

EXPERIMENTAL

standard care plus erdosteine for 10 days

Drug: Erdosteine

placebo

PLACEBO COMPARATOR

Standard care for exacerbation of COPD plus placebo

Drug: Placebo

Interventions

Erdosteine DRUG

capsule 300mg twice daily for 10 days

Also known as: erdotin

erdosteine

Placebo DRUG

placebo capsule, twice daily for 10 days

placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead
• Galen Limited: collaborator

Study Sites (1)

Castle Hill Hospital

Cottingham, East Yorkshire, HU16 5JQ, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Cough

Interventions

erdosteine

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Alyn H Morice, FRCP

  Hull and east Yorkshire NHS trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: August 6, 2010
• Study Start: August 10, 2010
• Primary Completion: October 12, 2011
• Study Completion: January 13, 2012
• Last Updated: June 19, 2019

Record last verified: 2019-06

Locations

GB (1)