Status:
COMPLETED
Nasal Lavage Study: Comparing Single Versus Multi Sample Lavages
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
Firestone Institute for Respiratory Health
Conditions:
Nasal Lavage Fluid
Eosinophils
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Nasal lavage could be an integral component of assessing airway inflammation. Research into the reproducibility of cell counts is key to understanding the value of lavage results. The objective of th...
Detailed Description
Nasal lavage is a relatively simple way to measure the degree of upper airway inflammation. It is useful in research because it is noninvasive, relatively discomfort-free, and simple to perform. Yet t...
Eligibility Criteria
Inclusion
- Subject is male or female aged 18 years or older.
- Subject understands the research project and agrees to participate by signing an informed consent agreement.
- Subject is able to successfully complete nasal lavage training session.
Exclusion
- Subjects with severe nasal polyps which prevent collecting adequate nasal lavage sample.
- Subjects who have undergone surgery to treat their nasal polyps (nasal polypectomy) within one year prior to visit one
- Subjects who have a known fungal infection of the nose and/or paranasal sinuses, nasal candidiasis, acute or chronic infectious sinusitis of viral or bacterial nature.
- Subjects who have had an upper respiratory tract infection within four weeks prior to visit one.
- Subjects having cystic fibrosis, Young's syndrome, primary ciliary dyskinesia, known HIV infection or alcohol abuse.
- Subjects with clinically significant, uncontrolled evidence of cardiovascular, neurological, hepatic, renal, respiratory, or any other medical condition that may interfere with the study.
- Subjects with a recent history (within six months) of a clinically significant psychiatric disorder other than mild depression.
- Subjects who have any clinically relevant deviation from normal in the general physical examination.
- Subjects who have received any depot, systemic or oral corticosteroid in the previous three months prior to the start of the study.
- Subjects who are using an intranasal steroid or antihistamine for their nasal symptoms and are unable to remain on a constant dose for four weeks prior to visit 1 or for the duration of the study.
- Females who are pregnant or lactating or are likely to become pregnant during the study or are less than 8 weeks postpartum. Women of childbearing age may be included if, in the opinion of the investigator, they are taking adequate contraceptive measures.
- Subjects who are unable to follow the instructions within this protocol or known inability to attend all clinic visits within the intervals stated.
- Subjects who have participated in a clinical trial involving an investigational or marketed drug within four weeks of visit one.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00229190
Start Date
September 1 2004
End Date
May 1 2005
Last Update
April 24 2007
Active Locations (1)
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1
Hamilton Health Sciences Corporation, McMaster Site
Hamilton, Ontario, Canada, L8N 3Z5