Dextromethorphan in smoking related cough

ISRCTN	ISRCTN46985377
DOI	https://doi.org/10.1186/ISRCTN46985377
Protocol serial number	N0084120889
Sponsor	Department of Health (UK)
Funders	The North and South Bank Research and Development Consortium (NHS R&D Support Funding) (UK), Procter & Gamble (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Respiratory: Smoking related cough
Intervention	Dextromethorphan versus placebo.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Dextromethorphan
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	01/06/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	42
Key inclusion criteria	50 volunteers between 18 - 70 years.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	11/03/2003
Date of final enrolment	01/06/2004

Academic Department of Medicine

Cottingham, East Yorkshire
HU16 5JQ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

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