Nasal Allergen Challenge in Rhinitic Subjects

Comparative Responses to Nasal Allergen Challenge in Allergic Rhinitic Subjects With or Without Asthma

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.

Study Overview

• Status: Completed
• Conditions: Asthma; Allergic Rhinitis
• Intervention / Treatment: Procedure: Nasal allergen challenge

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1V 4G5
      • Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Allergic asthmatic; Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.	Procedure: 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.
ACTIVE_COMPARATOR: Allergic rhinitic without asthma; Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Sputum Eosinophils Following Allergen Challenge	Eosinophil is an inflammatory cell found in the lungs. Sputum is obtained from hypertonic inhalation. patients expectorate in a sterile dish and mucus plugs are selected and treated to obtain cells. cells are transferred on a slide and a differential count is obtained where eosinophils are counted.	At 7 hours post first and last challenge compared to baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Nasal Lavage Eosinophils After Allergen Challenge	Change in nasal lavage eosinophil percentages in allergic asthmatic and allergic non asthmatic at baseline and at 7h post first and last challenge	At 7 hours post first and last challenge compared to baseline

Collaborators and Investigators

• Sponsor: Laval University
• Collaborators: AllerGen NCE Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (ACTUAL): March 1, 2008
• Study Completion (ACTUAL): March 1, 2008

Study Registration Dates

• First Submitted: January 13, 2011
• First Submitted That Met QC Criteria: January 27, 2011
• First Posted (ESTIMATE): January 31, 2011

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2019
• Last Update Submitted That Met QC Criteria: January 15, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Otorhinolaryngologic Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Asthma; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: FP-2005-3; CER1223 (OTHER: Ethics committee)