CysLT1-r Expression Following Allergen Exposure in Asthma and Allergic Rhinitis
Modulation of the CysLT1-r Expression Following Allergen Exposure in Non Asthmatic Subjects With Allergic Rhinitis and Mild Allergic Asthmatic Subjects Using the Induced Sputum Technique.
1 other identifier
interventional
30
1 country
1
Brief Summary
Cysteinyl leukotrienes (CysLTs) play an important role in asthma. CysLTs exert most of their bronchoconstrictive and pro-inflammatory effects through activation of the CysLT1-r. As allergic rhinitis appears to be a predisposing factor in the development of asthma and as CysLT-receptors seem to be implicated in the first steps of asthma manifestations, we think it would be of interest to determine if the CysLT1-r is a key mediator in the progression from allergic rhinitis to asthma. We believe it would be interesting to study the expression of the CysLT1-r Our goal is to assess baseline, as well as variations following allergen bronchoprovocations, in the expression of the CysLT1-r in mild asthmatic subjects compared with non asthmatic subjects with allergic rhinitis. Our hypothesis is that there will be a higher baseline expression of the CysLT1-r in asthmatic subjects compared with allergic rhinitis subjects and that allergen bronchoprovocations will induce an increase in the expression of the CysLT1-r in both groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable asthma
Started Oct 2003
Longer than P75 for not_applicable asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
February 27, 2008
CompletedFirst Posted
Study publicly available on registry
March 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedMay 12, 2008
November 1, 2007
5.3 years
February 27, 2008
May 7, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Change in CysLT1-r following allergen challenge
At 7h and 24h following conventional challenge
Secondary Outcomes (2)
Change in CysLT1-r following low dose allergen challenge
At 2 and 4 days of challenge
Difference in CysLT1-r expression in asthma and allergic rhinitis
At baseline
Study Arms (2)
1
ACTIVE COMPARATORConventional allergen challenge: increasing allergen doses given by nebulisation through the mouth and stopped when a 20% fall in forced expiratory volume in one second is obtained. Low dose allergen challenge: very low allergen doses given by nebulisation through the mouth. No more than a 5% fall in forced expiratory volume in one second. Nasal allergen challenge: One drop of increasing allergen doses on nasal mucosa.
2
ACTIVE COMPARATORLow dose allergen challenge: very low allergen doses given by nebulisation through the mouth. No more than a 5% fall in forced expiratory volume in one second. Nasal allergen challenge: One drop of increasing allergen doses on nasal mucosa.
Interventions
Conventional allergen challenge: increasing allergen doses given by nebulisation through the mouth and stopped when a 20% fall in forced expiratory volume in one second is obtained. Low dose allergen challenge: very low allergen doses given by nebulisation through the mouth. No more than a 5% fall in forced expiratory volume in one second. Nasal allergen challenge: One drop of increasing allergen doses on nasal mucosa.
Eligibility Criteria
You may qualify if:
- To have a positive reaction to one or more allergen on prick tests.
- Non smokers
- No respiratory track infection for at least one month prior to the study.
- Asthmatic subjects using only inhaled beta-2 agonists on an as needed basis for their asthma treatment.
- Asthmatic subjects with a history of asthma of at least 6 months.
- Asthmatic subjects with PC20 methacholine lower or equal to 8 mg/ml.
- Allergic rhinitic subjects never experienced any asthma symptoms or took any asthma medication in the past.
- Allergic rhinitic subjects with a PC20 methacholine higher than 16 mg/ml.
You may not qualify if:
- Smokers or ex smokers less than 6 months or more than 10 pack-years.
- Asthmatic subjects using or used in the past 3 months inhaled or oral corticosteroids.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laval Universitylead
Study Sites (1)
Centre de recherche de l'Hopital Laval
Québec, Quebec, G1V 4G5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Louis-Philippe Boulet, MD
Hopital Laval
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 27, 2008
First Posted
March 7, 2008
Study Start
October 1, 2003
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
May 12, 2008
Record last verified: 2007-11