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| ID | Type | Description | Link |
|---|---|---|---|
| BDUA2008 |
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Summary:
A picture is emerging of dendritic cells migrating through the blood to the airways following allergen inhalation in atopic asthmatics. Although the Koh and McCarthy articles present novel findings, both do not provide a comprehensive view of sputum DCs following allergen challenge. Therefore, the proposed study will examine the kinetics of mDCs and pDCs in the induced sputum of atopic asthmatics following inhalation of allergen.
Hypothesis:
Following allergen challenge, sputum myeloid and plasmacytoid DCs will migrate into the airway lumen in atopic asthmatics during the timeframe of the late asthmatic response.
Objective:
The objective of this study is to examine the kinetics of dendritic cells in induced sputum following allergen challenge in atopic asthmatic subjects.
Subjects will be put through two study periods. Each study period will consist of four visits and will be separated by 2-4 weeks. On the first visit, subjects will undergo screening procedures, including complete history and physical examination. In addition, methacholine inhalation challenge and skin-prick testing will be preformed to assess airway hyper-responsiveness and determine atopic status respectively. Lastly, sputum will be induced before challenge (0 hrs) and peripheral blood will be collected. On the second visit, subjects will inhale diluent or allergen and sputum will be collected 7 hours following inhalation challenge. Next, on the third visit, subjects will return 24 hours following inhalation challenge and sputum will be induced. On the final visit, subjects will return 72 hours following inhalation challenge and sputum will be collected, along with peripheral blood.
Before the next study period begins, there will be a washout period of 2-4 weeks. On the first visit of the second study period, a methacholine challenge will be performed to ensure the return of PC20 to within one doubling dose of baseline values. Also, sputum will be induced before challenge (0hrs) and peripheral blood will be collected. On the second visit, subjects will inhale diluent or allergen and sputum will be collected 7hrs following inhalation challenge. Next, on the third visit, subjects will return 24 hours following inhalation challenge and sputum will be induced. On the final visit, subjects will return 72 hours following inhalation challenge and sputum will be collected, along with peripheral blood.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diluent | Placebo Comparator | Inhalation challenge preformed with diluent. |
|
| Allergen | Active Comparator | Inhalation challenge preformed with allergen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aeroallergen | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Outcome Measure for This Study is the Number of Sputum Myeloid Dendritic Cells | Flow-cytometric acquisitions were used to determine the percentage of each type of mononuclear cell. These percentages were multiplied by the number of sputum mononuclear cells calculated by using total and differential cell counts of the sputum sample. | 24 hrs |
| The Primary Outcome Measure for This Study is the Number of Sputum Plasmacytoid Dendritic Cells | Flow-cytometric acquisitions were used to determine the percentage of each type of mononuclear cell. These percentages were multiplied by the number of sputum mononuclear cells calculated by using total and differential cell counts of the sputum sample. | 24 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant. | Before inhalation (0hrs) | |
| The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant | 7 hrs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul O'Byrne, MD | McMaster University | Principal Investigator |
| Gail Gauvreau, PhD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University | Hamilton | Ontario | L8N 3Z5 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diluent Then Allergen Challenge | Subjects were screened, then given a 2 week washout period. Samples collected on day 1 according to protocol. Day 2 diluent challenge was preformed and samples collected according to the protocol. Subjects returned on day 3 for 24 hour follow up and samples collected according to the protocol. Two week wash out period. Samples collected on day 1, after washout, according to protocol. Day 2, after washout, allergen challenge was preformed and samples collected according to the protocol. Subjects returned on day 3, after wash out, for 24 hour follow up and samples collected according to the protocol. |
| FG001 | Allergen Then Diluent Challenge | Subjects were screened, then given a 2 week washout period. Samples collected on day 1 according to protocol. Day 2 allergen challenge was preformed and samples collected according to the protocol. Subjects returned on day 3 for 24 hour follow up and samples collected according to the protocol. Two week wash out period. Samples collected on day 1, after washout, according to protocol. Day 2, after washout, dilluent challenge was preformed and samples collected according to the protocol. Subjects returned on day 3, after wash out, for 24 hour follow up and samples collected according to the protocol. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mild Asthmatics | Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | The Primary Outcome Measure for This Study is the Number of Sputum Myeloid Dendritic Cells | Flow-cytometric acquisitions were used to determine the percentage of each type of mononuclear cell. These percentages were multiplied by the number of sputum mononuclear cells calculated by using total and differential cell counts of the sputum sample. | Posted | Mean | Standard Deviation | number of cells/g of sputum | 24 hrs |
|
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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 | Mild Asthmatics | Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gail Gauvreau | McMaster University | 905-525-9140 | 22791 | gauvreau@mcmaster.ca |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant | 24 hrs |
| The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant | 72 hrs |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | The Primary Outcome Measure for This Study is the Number of Sputum Plasmacytoid Dendritic Cells | Flow-cytometric acquisitions were used to determine the percentage of each type of mononuclear cell. These percentages were multiplied by the number of sputum mononuclear cells calculated by using total and differential cell counts of the sputum sample. | Posted | Mean | Standard Deviation | number of cells/g of sputum | 24 hrs |
|
|
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| Secondary | The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant. | Not Posted | Before inhalation (0hrs) | Participants |
| Secondary | The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant | Not Posted | 7 hrs | Participants |
| Secondary | The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant | Not Posted | 24 hrs | Participants |
| Secondary | The Secondary Outcome Measure is the Level of Specific Chemokines Released in the Sputum Supernatant | Not Posted | 72 hrs | Participants |
| 0 |
| 12 |
| 0 |
| 12 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |