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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

January 13, 2011
May 24, 2013
November 2005
March 2008   (final data collection date for primary outcome measure)
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.
Change in sputum eosinophils following allergen challenge [ Time Frame: At 7hour post first and last challenge ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01286129 on ClinicalTrials.gov Archive Site
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
  • 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 ]
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Asthma
  • Allergic Rhinitis
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 asthmatic
    Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
    Intervention: Procedure: Nasal allergen challenge
  • 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.
    Intervention: Procedure: Nasal allergen challenge
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
March 2008
March 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01286129
FP-2005-3, CER1223
No
Laval University
Laval University
AllerGen NCE Inc.
Principal Investigator: Louis-Philippe Boulet, MD Institut universitaire de cardiologie et de pneumologie de Québec
Laval University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP