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Evaluate single dose (2 x 2.5mcg/puff; total dose 5mcg) effect of tiotropium administered 30 minutes prior to allergen challenge on allergen-induced EAR assessed as the maximal % fall in FEV1 after allergen inhalation compared to that of single dose (two puffs) matched placebo administered 30 minutes prior to allergen challenge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tiotropium treatment | Experimental | 2 puffs tiotropium |
|
| Placebo | Placebo Comparator | 2 puffs placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium (Spiriva®) | Drug | 2 puffs tiotropium prior to allergen challenge |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Early asthmatic response | Evaluate single dose (2 x 2.5mcg/puff; total dose 5mcg) effect of tiotropium administered 30 minutes prior to allergen challenge on allergen-induced EAR assessed as the maximal % fall in FEV1 after allergen inhalation compared to that of single dose (two puffs) matched placebo administered 30 minutes prior to allergen challenge. | 2 hours post-allergen challenge |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory response | 1. Evaluate effect of single dose tiotropium versus single dose matched placebo on airway inflammation five hours after allergen challenge through analyses of sputum eosinophil counts, and cytokine analysis including IL-4, 5, 13 and TSLP. | Five hours post-allergen challenge |
| FEV1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Saskatchewan | Saskatoon | Saskatchewan | S7M 2W2 | Canada |
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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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| ID | Term |
|---|---|
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| Placebo |
| Drug |
2 puffs placebo |
|
2. Evaluate bronchodilating effect of single dose tiotropium versus placebo on baseline lung function by comparing maximal FEV1 pre versus 30 minutes post treatment (i.e. prior to allergen challenge). |
| 30 minutes |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |