Condition category
Respiratory
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
27/10/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Caroline Wright

ORCID ID

Contact details

Academic Department of Medicine
Castle Hill Hospital
Castle Road
Cottingham
East Yorkshire
HU16 5JQ
United Kingdom
+44 (0)1482 875 875
c.e.wright@hull.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0084120889

Study information

Scientific title

A single centre, randomised, double blind, placebo controlled, crossover, pilot study to determine the efficacy and safety of dextromethorphan versus placebo for the treatment of smoking related cough

Acronym

Study hypothesis

This project was undertaken to evaluate the efficacy of dextromethorphan in the optimised cough formulation compared to placebo in a group of subjects with smoking related cough.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Respiratory: Smoking related cough

Intervention

Dextromethorphan versus placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

Dextromethorphan

Primary outcome measures

Reduction in cough frequency measured subjectively after waking on treatment day 1 over time periods 0 - 10, 10 - 20, 20 - 40 and 40 - 60 minutes.

Secondary outcome measures

1. Reduction in cough frequency on days 2 - 5
2. Change in cough symptoms (severity expectoration, chest pain, etc.,) and nocturnal cough
3. Change in cough threshold as measured via citric acid cough challenge

Overall trial start date

11/03/2003

Overall trial end date

01/06/2004

Reason abandoned

Eligibility

Participant inclusion criteria

50 volunteers between 18 - 70 years.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

42

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

11/03/2003

Recruitment end date

01/06/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Department of Medicine
Cottingham, East Yorkshire
HU16 5JQ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Industry

Funder name

The North and South Bank Research and Development Consortium (NHS R&D Support Funding) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Procter & Gamble (UK)

Alternative name(s)

Procter & Gamble, PandG, P&G

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18279476

Publication citations

  1. Results

    Ramsay J, Wright C, Thompson R, Hull D, Morice AH, Assessment of antitussive efficacy of dextromethorphan in smoking related cough: objective vs. subjective measures., Br J Clin Pharmacol, 2008, 65, 5, 737-741, doi: 10.1111/j.1365-2125.2008.03115.x.

Additional files

Editorial Notes