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Nasal Allergen Challenge in Rhinitic Subjects

This study has been completed.
Sponsor:
Information provided by:
Laval University
ClinicalTrials.gov Identifier:
NCT01286129
First received: January 13, 2011
Last updated: January 27, 2011
Last verified: December 2010
History of Changes
  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:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Laval University:

Primary Outcome Measures:
  • Change in sputum eosinophils following allergen challenge [ Time Frame: At 7hour post first and last challenge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in nasal lavage eosinophils after allergen challenge [ Time Frame: At 7hour post first and last challenge ] [ Designated as safety issue: No ]
  • Change in NBI after allergen challenge [ Time Frame: At early and late response over the 4 challenge days ] [ Designated as safety issue: No ]

Enrollment: 32
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 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 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 PC20 methacholine 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
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
Investigators
Principal Investigator: Louis-Philippe Boulet, MD Institut universitaire de cardiologie et de pneumologie de Québec
  More Information

No publications provided

Responsible Party: Louis-Philippe Boulet, Institut universitaire de cardiologie et de pneumologie de Québec
ClinicalTrials.gov Identifier: NCT01286129     History of Changes
Other Study ID Numbers: FP-2005-3, CER1223
Study First Received: January 13, 2011
Last Updated: January 27, 2011
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 June 18, 2013