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ISRCTN
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ISRCTN46985377
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ClinicalTrials.gov identifier
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Public title
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Dextromethorphan in smoking related cough
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Scientific title
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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
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Acronym
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N/A
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Serial number at source
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N0084120889
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Study hypothesis
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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.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Respiratory: Smoking related cough
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Participants - inclusion criteria
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50 volunteers between 18 - 70 years.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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11/03/2003
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Anticipated end date
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01/06/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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42
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Interventions
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Dextromethorphan versus placebo.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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
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Sources of funding
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1. The North and South Bank Research and Development Consortium (NHS R&D Support Funding) (UK)
2. Procter & Gamble (UK)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/18279476
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Contact name
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Miss
Caroline
Wright
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Address
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Academic Department of Medicine
Castle Hill Hospital
Castle Road
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City/town
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Cottingham, East Yorkshire
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Zip/Postcode
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HU16 5JQ
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Country
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United Kingdom
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Fax
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+44 (0)1482 622248
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Email
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c.e.wright@hull.ac.uk
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Sponsor
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Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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12/09/2003
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Last edited
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22/02/2008
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Date ISRCTN assigned
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12/09/2003
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