Nasal Allergen Challenge in Rhinitic Subjects

This study has been completed.
Sponsor:
Collaborator:
AllerGen NCE Inc.
Information provided by (Responsible Party):
Laval University
ClinicalTrials.gov Identifier:
NCT01286129
First received: January 13, 2011
Last updated: May 24, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Asthma
Allergic Rhinitis
Procedure: Nasal allergen challenge

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Comparative Responses to Nasal Allergen Challenge in Allergic Rhinitic Subjects With or Without Asthma

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • Change in Sputum Eosinophils Following Allergen Challenge [ Time Frame: At 7 hours post first and last challenge compared to baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: At 7 hours post first and last challenge compared to baseline ] [ Designated as safety issue: No ]
    Change in nasal lavage eosinophil percentages in allergic asthmatic and allergic non asthmatic at baseline and at 7h post first and last challenge


Enrollment: 45
Study Start Date: November 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01286129

Locations
Canada, Quebec
Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Laval University
AllerGen NCE Inc.
Investigators
Principal Investigator: Louis-Philippe Boulet, MD Institut universitaire de cardiologie et de pneumologie de Québec
  More Information

No publications provided

Responsible Party: Laval University
ClinicalTrials.gov Identifier: NCT01286129     History of Changes
Other Study ID Numbers: FP-2005-3, CER1223
Study First Received: January 13, 2011
Results First Received: March 29, 2012
Last Updated: May 24, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:
Asthma
Rhinitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on July 29, 2014