Nasal hyper-reactivity in multiple chemical sensitivity and chronic fatigue syndrome: randomised double blind, placebo-controlled, cross-over, nasal challenge study to evaluate neural and vascular responsiveness
| ISRCTN | ISRCTN52896230 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52896230 |
| Secondary identifying numbers | N0231117469 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 07/04/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Peter Howarth
Scientific
Scientific
IIR (RCMB), MP 810
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 023 8079 6990 |
|---|---|
| p.h.howarth@soton.ac.uk |
Study information
| Study design | Randomised double blind, placebo controlled cross over design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study acronym | N?A |
| Study objectives | To evaluate and gain insight into nasal hyper-reactivity in multiple chemical sensitivity and chronic fatigue syndrome. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Ear, Nose and Throat |
| Intervention | Not provided at time of registration |
| Intervention type | Other |
| Primary outcome measure | 1. Concentration at which challenge is discontinued 2. Nasal lavage inflammatory proteins pre and post 3. Magnitude of symptoms |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 27/09/2002 |
| Completion date | 26/09/2007 |
| Reason abandoned (if study stopped) | Lack of staff/facilities/resources |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 36 |
| Key inclusion criteria | 36 subjects between age of 18 - 60 years, 12 of which are healthy controls. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 27/09/2002 |
| Date of final enrolment | 26/09/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
IIR (RCMB), MP 810
Southampton
SO16 6YD
United Kingdom
SO16 6YD
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
Government
Southampton University Hospitals NHS Trust (UK)
No information available
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 |
