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| ID | Type | Description | Link |
|---|---|---|---|
| CER1223 | Other Identifier | Ethics committee |
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| Name | Class |
|---|---|
| AllerGen NCE Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allergic asthmatic | Active Comparator | Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt. |
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| Allergic rhinitic without asthma | Active Comparator | Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal allergen challenge | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sputum Eosinophils Following Allergen Challenge | 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. | At 7 hours post first and last challenge compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Nasal Lavage Eosinophils After Allergen Challenge | Change in nasal lavage eosinophil percentages in allergic asthmatic and allergic non asthmatic at baseline and at 7h post first and last challenge | At 7 hours post first and last challenge compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louis-Philippe Boulet, MD | Institut universitaire de cardiologie et de pneumologie de Québec, University Laval | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec | Québec | Quebec | G1V 4G5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21507261 | Derived | Rousseau MC, Boulay ME, Goronfolah L, Denburg J, Keith P, Boulet LP. Comparative responses to nasal allergen challenge in allergic rhinitic subjects with or without asthma. Allergy Asthma Clin Immunol. 2011 Apr 20;7(1):8. doi: 10.1186/1710-1492-7-8. |
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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.
Subjects were recruited from advertisement between November 2005 and october 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Allergic Asthmatic | Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt. |
| FG001 | Allergic Rhinitic Without Asthma | Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Allergic Asthmatic | Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt. |
| BG001 | Allergic Rhinitic Without Asthma | Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Sputum Eosinophils Following Allergen Challenge | 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. | Posted | Mean | Standard Error | percentage of sputum eosinophils | At 7 hours post first and last challenge compared to baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Allergic Asthmatic | Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Louis-Philippe Boulet, principal investigator | IUCPQ | 418-656-4747 | lpboulet@med.ulaval.ca |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change in Nasal Lavage Eosinophils After Allergen Challenge | Change in nasal lavage eosinophil percentages in allergic asthmatic and allergic non asthmatic at baseline and at 7h post first and last challenge | Posted | Mean | Standard Error | percentage of nasal lavage eosinophils | At 7 hours post first and last challenge compared to baseline |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Allergic Rhinitic Without Asthma | Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt. | 0 | 13 | 0 | 13 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| 7h post last challenge percentage eosinophils |
|