Status:
COMPLETED
Biopsies and Polyps
Lead Sponsor:
Laval University
Conditions:
Nasal Polyps
Asthma
Eligibility:
All Genders
18-65 years
Brief Summary
Background: Nasal polyps are found in about 5% of asthmatic patients.A close link exists between the upper and lower airways and the concept of the "United Airways" has emerged mainly from studies on ...
Detailed Description
The study will include 2 visits separated by a maximum of 7 days. During the first visit, subjects' characteristics will be documented by a locally validated questionnaire. Allergy skin prick tests, s...
Eligibility Criteria
Inclusion
- For all subjects:
- Non smoking men or women aged 18 to 65 years old.
- Subjects will have nasal polyps as defined above.
- For asthmatic subjects:
- Subjects will have a history consistent with asthma according to the criteria of the ATS\[18\] defined on the basis of episodic or persistent chest tightness, wheeze or cough in the past 6 months. At entry into the study, FEV1 will be over 70% predicted.
- Asthma will have been stable for at least 3 months before entering the trial.
- Asthma medication will have been stable for at least 1 month prior to the study.
- For non asthmatic subjects:
- A methacholine challenge test with a PC20 (provoking concentration of methacholine to cause a 20% fall in FEV1) over 16 mg/mL.
Exclusion
- For all subjects:
- Smoking (current smoking) or ex-smoking (les than 6 months or history of more than 10 pack-year of smoking).
- Use of anti-leukotriene medication within the last 3 months.
- Use of systemic corticosteroids within the last 3 months.
- Use of anti-coagulant therapy.
- Recent (less than 1 month) upper or lower respiratory tract infection, any other condition that may interfere with the evaluations.
- Pregnancy, breast-feeding or planned pregnancy during the study. Fertile woman not using acceptable contraceptive measures, as judged by the investigator.
- Subjects unable to perform or with contraindications to the tests proposed.
- Subjects who are, in the opinion of the investigator, mentally or legally incapacitated thus preventing informed consent from being obtained.
- For asthmatic subjects:
- Unstable asthma shown by respiratory symptoms and B2-agonists need more than 3 times/week and nocturnal asthma symptoms.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00835445
Start Date
July 1 2007
End Date
September 1 2009
Last Update
January 7 2011
Active Locations (1)
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1
Hopital Laval
Ste-Foy, Quebec, Canada, G1V 4G5