Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0236169531
Study information
Scientific title
Acronym
Study hypothesis
To determine the effects of low concentrations of carbon monoxide gas on the motility of human nasal cilia cells.
Ethics approval
Not provided at time of registration
Study design
Prospective single-blinded controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
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
Intervention
A steady flow of normal air (100 ml/min) is fed into one nostril; the other nostril is left unblocked so air can escape. Simultaneously, the subject breathes via the mouth into an oxygen mouthpiece so that the soft palate closes the mouth from the nasal cavity, and gas flows from one nostril to the other without being inspired into the lungs. This lasts for 10 minutes. The saccharine test is then used to measure the nasal mucociliary clearance time. A saccharine granule is placed in the nose at the same site in all subjects. The time required for the subject to taste the sweetness is measured. Oral only breathing is maintained during the saccharine test. The test is repeated with a 100 cc/min flow of low concentration CO gas (30 ppm) fed into the nostril. The subject is blinded and does not know which gas is fed into the nostril. The nostril into which the gas is fed into is randomised. The background ambient CO level is measured using a commercially available CO detector.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
The mucociliary clearance time, measured as the time to taste the saccharin
Secondary outcome measures
No secondary outcome measures
Overall trial start date
21/08/2005
Overall trial end date
21/08/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Healthy adult volunteers between 18 and 40 years old. Volunteers will be recruited from amongst medical and nursing staff and students at St Georges Hospital, London. They will be personally approached by the principle investigator.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Added 21/07/2008: 26
Participant exclusion criteria
1. Smokers
2. Subjects with a history of chronic respiratory or nasal disease
3. Symptomatic upper respiratory tract infection during the previous 4 weeks
4. Subjects who have taken systemic or topical steroids or anti-histamine therapy during the previous 4 weeks
5. Presence of significant mechanical intra-nasal deformity such as a septal deviation or bony spur
6. Children under 16 years old
7. Vulnerable groups including those with learning difficulty, mental illness and dementia
8. Pregnancy
9. Other conditions that increase risk are hyperthyroidism, obesity, bronchitis, asthma, pre-existing heart disease and alcoholism
Recruitment start date
21/08/2005
Recruitment end date
21/08/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Otolaryngology
London
SW17 0QT
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
St George's Healthcare NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding (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
Basic results (scientific)
Publication list