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| Name | Class |
|---|---|
| i3 Research | INDUSTRY |
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The researchers propose to study the airways of asthmatics given TPI ASM8 for 14 days, and examine the protective effects on allergen-induced bronchoconstriction, hyperresponsiveness and airway inflammation.
Early and late asthmatic responses were attenuated by ASM8 and by placebo solution.Methacholine challenge was not affected by study medication. Other parameters were unchanged.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No.1 ASM8 (oligonucleotide) | Experimental | TPI ASM8 1mg/mL in phosphate buffered saline (PBS) solution; 1 mg will be administered daily (morning) by inhalation |
|
| Phosphate Buffer solution | Placebo Comparator | Placebo solution (PBS) will be administered daily in the form of 1 mL of PBS (phosphate buffered saline) by inhalation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPI ASM8 | Biological | Administered with the I-Neb device from Respironics once daily by inhalation over 2 treatment periods of 14 days each |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and allergen-induced maximum decrease in FEV1 for Late Asthmatic Response | Safety (Trial duration) + LAR (Day 14) |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Endpoints only: EAR on Day 14, AMP-induced airway hyperresponsiveness on Day 10,eNO on Day 14, PK/PD in sputum and plasma | study duration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian O'Connor, MD | Kings College Hospital, London, United Kingdom | Principal Investigator |
| Rene Pageau, M.Sc.Pharm | Topigen Pharmaceuticals, Montreal, Quebec/Canada | Study Director |
| Pierluigi Paggiaro, Prof | University of Pisa, Pisa, Italy | Principal Investigator |
| Dave Singh, MD | Evaluation Unit, Manchester, UK | Principal Investigator |
| Peter J. Sterk, MD | University of Amsterdam, Amsterdam, The Netherlands | Principal Investigator |
| Piero Maestrelli, Prof. | University of Padova | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King's College inLondon | London | London | SE1 9RT | United Kingdom |
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| ID | Term |
|---|---|
| C559988 | TPI ASM8 |
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| placebo | Biological | Administered with the I-Neb device from Respironics once daily by inhalation over 2 treatment periods of 14 days each |
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