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
Results First Received: March 29, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Asthma
Allergic Rhinitis
Intervention: Procedure: Nasal allergen challenge

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from advertisement between November 2005 and october 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After enrollment, there was a one to 7 days run-in period. Subjects that could not produce a quality sputum sample were excluded from the trial.

Reporting Groups
  Description
Allergic Asthmatic Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
Allergic Rhinitic Without Asthma Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.

Participant Flow:   Overall Study
    Allergic Asthmatic     Allergic Rhinitic Without Asthma  
STARTED     27     18  
COMPLETED     19     13  
NOT COMPLETED     8     5  
Withdrawal by Subject                 4                 1  
Could not comply with study requirements                 4                 4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Allergic Asthmatic Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
Allergic Rhinitic Without Asthma Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
Total Total of all reporting groups

Baseline Measures
    Allergic Asthmatic     Allergic Rhinitic Without Asthma     Total  
Number of Participants  
[units: participants]
  27     18     45  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     27     18     45  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  24  ± 4     24  ± 7     24  ± 5  
Gender  
[units: participants]
     
Female     20     8     28  
Male     7     10     17  
Region of Enrollment  
[units: participants]
     
Canada     27     18     45  



  Outcome Measures
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1.  Primary:   Change in Sputum Eosinophils Following Allergen Challenge   [ Time Frame: At 7 hours post first and last challenge compared to baseline ]

2.  Secondary:   Change in Nasal Lavage Eosinophils After Allergen Challenge   [ Time Frame: At 7 hours post first and last challenge compared to baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Louis-Philippe Boulet, principal investigator
Organization: IUCPQ
phone: 418-656-4747
e-mail: lpboulet@med.ulaval.ca


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