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 |
| Protocol serial number | N0231117469 |
| Sponsor | Department of Health (UK) |
| Funder | Southampton University Hospitals NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double blind, placebo controlled cross over design |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. Concentration at which challenge is discontinued |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| 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 sample size at registration | 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
- United Kingdom
- England
Study participating centre
IIR (RCMB), MP 810
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
