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
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
-
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.