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 individuals 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 olfactometers 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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list