Condition category
Ear, Nose and Throat
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
16/01/2014
Prospective/Retrospective
Prospectively 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

Mr Carl Philpott

ORCID ID

Contact details

St Paul's Sinus Centre
St Paul's Hospital
1081 Burrard Street
Vancouver
BC
V6Z 1Y6
Canada
+1 604 806 9926
carl.philpott@btinternet.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0274181493

Study information

Scientific title

Acronym

Study hypothesis

The aim of this study is to evaluate the whether pheromones can influence the occurrence of superosmia during an olfactory threshold test.

Ethics approval

Added September 2008: UCLH Committee (UK), ref 06/Q0505/10, 04/08/06 (Ethics Approval), 18/05/07 (R&D Approval).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Ear, Nose and Throat: Superosmia

Intervention

The study will take place at the ENT departments of Leicester Royal Infirmary and the West Suffolk Hospital. One hundred subjects will be recruited from amongst hospital staff who consider themselves to have a 'normal' sense of smell and no active sino-nasal disease. The study will take the form of a single-blinded randomised controlled trial. Subjects selected will be invited to undergo a 15 minute smell test and examination of their nose. They will be tested with a computer-driven olfactometer which enables a quantitative threshold test to be performed for several odours: phenethyl alcohol (roses), eucalyptol (menthol), acetic acid (vinegar) and mercaptan (gas). These odours have been shown to represent distinct entities in an individual’s sense of smell (1) and the test format has been validated in our previous work (2). The test involves the patient being seated in front of the olfactometer and the process of the test is explained to them by the researcher. At the voice prompts from the computer attached to the olfactometer, they will be asked to deliver two puffs of air from the spout using the two buttons attached to the olfactometer’s valve. The puffs of air are paired, one being a blank, the other containing the odour and they will be asked to identify the odour repeatedly like this in a forced response format until they have defined a threshold.

Following this they will then be exposed to either a pheromone (delta4,16-androstadien-3-one for female subjects and 1,3,5,(10),16-estratetraen-3-ol for male subjects) or sterile water - 1cm3 of the solution will be placed on a mask and held in front of the subjects nose for 2 minutes. The substance applied to the mask will be determined by use of a closed envelope system. Subjects will be then retested for their olfactory thresholds using the technique described above. This whole process will take less than an hour and no further involvement will be required of the individual subjects.

1. Gaskin JA, Robinson A, Philpott CM, Goodenough PC, Murty GE. Are patients cross-sensitive to odours in parallel threshold tests Chemical Senses 2006
2. Philpott CM, Dhanji F, Wolstenholme CR, Goodenough PC, Clark A, Murty GE. Eucalyptol olfactory threshold testing with a computer driven olfactometer. Journal of Laryngology and Otology 2006

Updated 16/01/2014: The study did not proceed due to a lack of funds and personnel.

Intervention type

Drug

Phase

Not Specified

Drug names

pheromones

Primary outcome measures

Olfactory thresholds

Secondary outcome measures

No secondary outcome measures

Overall trial start date

11/08/2008

Overall trial end date

01/08/2009

Reason abandoned

Lack of funding/sponsorship

Eligibility

Participant inclusion criteria

Anyone who considers themselves to have a normal sense of smell.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

Number of participants: 100 total. 50 from West Suffolk.

Participant exclusion criteria

People who are found to be hyposmic/anosmic (ie lacking in ability to detect odours at normal levels), people with sino-nasal disease, people unable to understand spoken English or who are mentally impaired.

Recruitment start date

11/08/2008

Recruitment end date

01/08/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Paul's Sinus Centre
Vancouver, BC
V6Z 1Y6
Canada

Sponsor information

Organisation

University Hospitals of Leicester NHS Trust (UK)

Sponsor details

University Hospitals of Leicester NHS Trust Headquarters
Level 3
Balmoral Building
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.uhl-tr.nhs.uk/

Funders

Funder type

Government

Funder name

West Suffolk Hospitals NHS Trust (UK), NHS R&D Support Funding

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