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This is a randomized, double-blind, placebo-controlled, 3-way crossover trial to evaluate the efficacy and safety of two different doses of inhaled TPI ASM8 administered daily for 14 days for the treatment of allergic asthma and allergen-induced asthma.
Two doses of TPI ASM8 will be compared to placebo and look at the effect on asthmatic responses after an allergen challenge during a 3-way cross over design. Sputum inflammation , mRNA gene expression on target receptors, ECP , biomarkers of mast cells activation et PK profile will be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPI ASM8 low dose | Active Comparator |
| |
| TPI ASM8 high dose | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPI ASM8 | Drug | ASM8 4mg/mL (low dose) daily for 14 days by inhalation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the AUC of the late asthmatic response (LAR) between treatments and placebo | The area under the curve fo the late asthmatic response(% fall in FEV1)(between 3-7 hrs post allergen challenge) will be compared between the 2 doses of TPI ASM8 and the placebo | Day 14 (Between 3-7 hr post-AIC) |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the early and late asthmatic responses between active treatments and placebo after 14 days treatment | Compare the % fall in FEV1 during the EAR and the LAR post-allergen challenge on Day 14. | Day 14 |
| Compare the Methacholine Hyperresponsiveness (PC20) between treatment pre and post allergen challenge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul O'Byrne, MD | McMaster University | Study Chair |
| Rene Pageau, M.Sc Pharm | Pharmaxis Ltd | Study Director |
| Louis-Philippe Boulet, MD | Hopital Laval, Quebec | Principal Investigator |
| Richard Leigh, MD | University of Calgary | Principal Investigator |
| Gail M Gauveau, PhD | McMaster University | Principal Investigator |
| Mark Fitzgerald, MD | Vancouver Coastal Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Research Innovation Centre | Calgary | Alberta | T2N 4N1 | Canada | ||
| Vancouver Coastal Health Research Institute |
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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 |
|---|---|
| C559988 | TPI ASM8 |
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| TPI ASM8 |
| Drug |
ASM8 4mg/mL (high dose) daily for 14 days by inhalation |
|
| TPI ASM8 | Drug | Placebo PBS solution daily for 14 days by inhalation |
|
We will compare the PC20( provocative concentration of methacholine) that cause a 20% fall in FEV1 |
| Day 13 and Day 15 (Pre & post AIC) |
| Effect of ASM8 on mast cells (as measured by specific biomarkers) | The leukotriene E4 and 9-11B PGF2 wil be measured in urine and plasma to determine the level of mast cells activation following the allergen challenge | Day 14 (pre, post and and peri-AIC) |
| Sputum inflammation indicators (Eos, neutrophils, etc.) | We will measure the levels of total cell counts and the differential to evaluate the degree of inflammation between treatments and placebo. | Day 14 and Day 15 |
| Vancouver |
| British Columbia |
| V5Z 1M9 |
| Canada |
| McMaster University | Hamilton | Ontario | L8N 3Z5 | Canada |
| Laval Centre de Pneumologie Chest Division | Québec | Quebec | G1V4G5 | Canada |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |