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Nasal Allergen Challenge in Rhinitic Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01286129
First Posted: January 31, 2011
Last Update Posted: July 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
AllerGen NCE Inc.
Information provided by (Responsible Party):
Laval University
Results First Submitted: March 29, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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 
Overall Participants Analyzed 
[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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Laval University
ClinicalTrials.gov Identifier: NCT01286129     History of Changes
Other Study ID Numbers: FP-2005-3
CER1223 ( Other Identifier: Ethics committee )
First Submitted: January 13, 2011
First Posted: January 31, 2011
Results First Submitted: March 29, 2012
Results First Posted: July 1, 2013
Last Update Posted: July 1, 2013