Recruiting

Observational StudyCysLT1-r Expression Following Allergen Exposure in Asthma and Allergic Rhinitis

Sponsor:

Laval University

Code:

NCT00631254

Conditions

Asthma

Allergic Rhinitis

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Allergen challenge

Study Details

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.

Conditions

Asthma

Allergic Rhinitis

Study ID

NCT00631254

Start date

Oct, 2003

Status verified date

Nov, 2007

Completion date

Jan, 2009

Anticipated

Primary completion date

Jan, 2009

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: 1

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.

active comparator: 2

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.

Interventions

Allergen challenge

Primary outcome measure

Change in CysLT1-r following allergen challenge [ Time Frame: At 7h and 24h following conventional challenge ]

Central Contacts and Locations

Central contacts

Marie-Eve Boulay, MSc

418-656-8711 Marie-Eve.Boulay@crhl.ulaval.ca

Philippe Prince, MSc

418-656-8711 Philippe.Prince@crhl.ulaval.ca

Locations

Centre de recherche de l'Hopital Laval

Recruiting

Quebec, Canada, G1V 4G5

More Information

Sponsor

Laval University

Last update posted

May 12, 2008

Last verified

Nov, 2007

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2008-05-12.