Tolerability study of nasal delivery of humidified & warmed air
Not Applicable
Completed
- Conditions
- Tolerability in health, for further use on patients with the common cold.Respiratory - Other respiratory disorders / diseases
- Registration Number
- ACTRN12614000183684
- Lead Sponsor
- Fisher and Paykel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
10 healthy subjects without recent upper respiratory tract infection (defined as sore throat, cough, runny nose and/or raised temperature (subjective or objectively measured) within the last 7 days)
Exclusion Criteria
1.Age under 18 years
2.Asthma or Chronic Obstructive Pulmonary Disease (COPD) requiring medication use in the past 6 months
3. Sinusitis and/or use of nasal sprays in the last 7 days
4.Current smoker, defined as cigarette use in the last month
5.Any other condition which, at the investigator’s discretion, is believed may present a safety risk or impact the feasibility of the study or the study results.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intervention Tolerability Questionnaire results[Following intervention A and B at the end of visit 1 and visit 3, ie approximately 7 hours after time 0 at each visit.]
- Secondary Outcome Measures
Name Time Method umber of participants who did not tolerate the intervention for 60 minutes, and length of time it was tolerated for<br><br>[Following intervention A and B at the end of visit 1 and visit 3, ie approximately 7 hours after time 0 at each visit.];Effect on nasal mucociliary function - change in saccharin test times from baseline [Ten minutes after intervention A and B (approximately 7 hours and ten minutes after time 0) in visit 1 and 3, and 22-26 hours following Time 0 in visit 2 and 4. ]