Condition category
Ear, Nose and Throat
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
22/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Stephen Lo

ORCID ID

Contact details

Department of Otolaryngology
St George's Hospital Medical School
London
SW17 0QT
United Kingdom
+44 (0)20 8725 2050

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 measures

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

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 George’s 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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes