Nasal Allergen Challenge in Rhinitic Subjects

NCT ID: NCT01286129

Last Updated: 2019-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2008-03-31

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.

Conditions

Asthma; Allergic Rhinitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Allergic asthmatic

Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.

Group Type: ACTIVE_COMPARATOR

Nasal allergen challenge

Intervention Type: PROCEDURE

Allergen sprayed into nostrils. Allergen used will be house dust mite or cat allergen. Allergens will be given in increasing ten-fold dilutions until a positive response occurs.

Allergic rhinitic without asthma

Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.

Group Type: ACTIVE_COMPARATOR

Nasal allergen challenge

Intervention Type: PROCEDURE

Allergen sprayed into nostrils. Allergen used will be house dust mite or cat allergen. Allergens will be given in increasing ten-fold dilutions until a positive response occurs.

Interventions

Nasal allergen challenge

Allergen sprayed into nostrils. Allergen used will be house dust mite or cat allergen. Allergens will be given in increasing ten-fold dilutions until a positive response occurs.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AllerGen NCE Inc.

INDUSTRY

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Louis-Philippe Boulet, MD

Role: PRINCIPAL_INVESTIGATOR

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Locations

Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 21507261 (View on PubMed)

Other Identifiers

CER1223

Identifier Type: OTHER

Identifier Source: secondary_id

FP-2005-3

Identifier Type: -

Identifier Source: org_study_id