Clinical trial NCT01286129: Nasal Allergen Challenge in Rhinitic Subjects
Official title: Comparative Responses to Nasal Allergen Challenge in Allergic Rhinitic Subjects With or Without Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Allergic Rhinitis
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: AllerGen NCE Inc.
First posted: 2011-01-31
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: Nasal allergen challenge (NAC) is useful to study the pathophysiology of rhinitis, and multiple challenges may more adequately approximate natural exposure.

Objective: To determine the effect of 4 consecutive daily NAC, on clinical and inflammatory parameters in rhinitics with or without asthma.

Detailed description: The study will be performed outside the pollen season. On a baseline visit, 2 to 7 days prior to control challenge, allergy skin prick tests and methacholine inhalation test will be done. Prior to first allergen challenge, skin titration will be done using tenfold dilutions of the allergen chosen for nasal challenges. Subsequent to baseline visit, a control challenge will be done, followed, a week later, by repeated NACs. NACs will be done over 4 consecutive days, in the morning. Nasal peak inspiratory flows (NPIF), oral peak expiratory flows (PEF), and symptoms will be recorded at baseline and at regular intervals over 7 hours post-challenge on each challenge day. Induced sputum and nasal lavage specimen will be obtained 7 hours following the control challenge and the first and last NAC.

Eligibility criteria: 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.
* Positive reaction to cat hair and/or house dust mite (Dermatophagoides pteronyssinus) aeroallergens on allergy skin prick tests and report rhinitis symptoms when exposed to an environment containing this allergen.
* 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 provocative concentration of methacholine (PC20 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.

Primary outcomes:
measure: Change in Sputum Eosinophils Following Allergen Challenge
timeFrame: At 7 hours post first and last challenge compared to baseline
Secondary outcomes:
measure: Change in Nasal Lavage Eosinophils After Allergen Challenge
timeFrame: At 7 hours post first and last challenge compared to baseline
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec
state: Quebec
Study officials:
affiliation: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
name: Louis-Philippe Boulet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rousseau MC, Boulay ME, Goronfolah L, Denburg J, Keith P, Boulet LP. Comparative responses to nasal allergen challenge in allergic rhinitic subjects with or without asthma. Allergy Asthma Clin Immunol. 2011 Apr 20;7(1):8. doi: 10.1186/1710-1492-7-8.