Dextromethorphan in smoking related cough
| 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
Scientific
Academic Department of Medicine
Castle Hill Hospital
Castle Road
Cottingham, East Yorkshire
HU16 5JQ
United Kingdom
| Phone | +44 (0)1482 875 875 |
|---|---|
| c.e.wright@hull.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Dextromethorphan |
| Primary outcome measure | 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 study start date | 11/03/2003 |
| Completion date | 01/06/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Academic Department of Medicine
Cottingham, East Yorkshire
HU16 5JQ
United Kingdom
HU16 5JQ
United Kingdom
Sponsor information
Department of Health (UK)
Government
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)
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
