Contact information
Type
Scientific
Primary contact
Dr Peter Howarth
ORCID ID
Contact details
IIR (RCMB)
MP 810
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 023 8079 6990
p.h.howarth@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0231117469
Study information
Scientific title
Acronym
N?A
Study hypothesis
To evaluate and gain insight into nasal hyper-reactivity in multiple chemical sensitivity and chronic fatigue syndrome.
Ethics approval
Not provided at time of registration
Study design
Randomised double blind, placebo controlled cross over design
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Ear, Nose and Throat
Intervention
Not provided at time of registration
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
27/09/2002
Overall trial end date
26/09/2007
Reason abandoned
Lack of staff/facilities/resources
Eligibility
Participant inclusion criteria
36 subjects between age of 18 - 60 years, 12 of which are healthy controls.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
36
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
27/09/2002
Recruitment end date
26/09/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
IIR (RCMB), MP 810
Southampton
SO16 6YD
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Southampton University Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary