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ISRCTN
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ISRCTN54813440
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ClinicalTrials.gov identifier
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Public title
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Effects of carbon monoxide on nasal mucociliary clearance.
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0236169531
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Study hypothesis
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To determine the effects of low concentrations of carbon monoxide gas on the motility of human nasal cilia cells.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Prospective single-blinded controlled study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Ear, Nose and Throat:
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Participants - inclusion criteria
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Healthy adult volunteers between 18 and 40 years old. Volunteers will be recruited from amongst medical and nursing staff and students at St George’s Hospital, London. They will be personally approached by the principle investigator.
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Participants - exclusion criteria
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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, preexisting heart disease and alcoholism
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Anticipated start date
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21/08/2005
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Anticipated end date
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21/08/2006
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Added 21 July 2008: 26
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Interventions
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A steady flow normal air (100ml/min) is fed into one nostril; the other nostril is left unblocked so air can escape. Simultaneously, the subject breaths 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 100cc/min flow of low concentration CO gas (30ppm) 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.
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Primary outcome measure(s)
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The mucociliary clearance time, measured as the time to taste the saccharin.
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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St George's Healthcare NHS Trust (UK)
NHS R&D Support Funding, no external funding
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Trial website
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Publications
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Contact name
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Mr
Stephen
Lo
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Address
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Department of Otolaryngology
St George's Hospital Medical School
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City/town
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London
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Zip/Postcode
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SW17 0QT
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Country
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United Kingdom
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Tel
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+44 020 8725 2050
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Fax
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+44
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Email
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stephenlo@lycos.co.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2006 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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29/09/2006
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Last edited
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28/09/2011
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Date ISRCTN assigned
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29/09/2006
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