Condition category
Ear, Nose and Throat
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
07/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes