ISRCTN ISRCTN46985377
DOI https://doi.org/10.1186/ISRCTN46985377
Secondary identifying numbers N0084120889
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
27/10/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Caroline Wright
Scientific

Academic Department of Medicine
Castle Hill Hospital
Castle Road
Cottingham, East Yorkshire
HU16 5JQ
United Kingdom

Phone +44 (0)1482 875 875
Email c.e.wright@hull.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA 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
Study objectivesThis 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedRespiratory: Smoking related cough
InterventionDextromethorphan versus placebo.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Dextromethorphan
Primary outcome measureReduction 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 measures1. 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 study start date11/03/2003
Completion date01/06/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants42
Key inclusion criteria50 volunteers between 18 - 70 years.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment11/03/2003
Date of final enrolment01/06/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Industry

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

No information available

Procter & Gamble (UK)
Government organisation / For-profit companies (industry)
Alternative name(s)
Procter & Gamble, PandG, The Procter & Gamble Company, P&G
Location
United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2008 Yes No