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Nasal Allergen Challenge in Rhinitic Subjects

Primary Purpose

Asthma, Allergic Rhinitis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Nasal allergen challenge
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Allergic asthmatic

Allergic rhinitic without asthma

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 13, 2011
Last Updated
January 15, 2019
Sponsor
Laval University
Collaborators
AllerGen NCE Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01286129
Brief Title
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laval University
Collaborators
AllerGen NCE Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Allergic Rhinitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Allergic asthmatic
Arm Type
Active Comparator
Arm Description
Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
Arm Title
Allergic rhinitic without asthma
Arm Type
Active Comparator
Arm Description
Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
Intervention Type
Procedure
Intervention Name(s)
Nasal allergen challenge
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Sputum Eosinophils Following Allergen Challenge
Description
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.
Time Frame
At 7 hours post first and last challenge compared to baseline
Secondary Outcome Measure Information:
Title
Change in Nasal Lavage Eosinophils After Allergen Challenge
Description
Change in nasal lavage eosinophil percentages in allergic asthmatic and allergic non asthmatic at baseline and at 7h post first and last challenge
Time Frame
At 7 hours post first and last challenge compared to baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis-Philippe Boulet, MD
Organizational Affiliation
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21507261
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.
Results Reference
derived

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Nasal Allergen Challenge in Rhinitic Subjects

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