Trials / Completed
CompletedNCT00822861
Efficacy and Safety of Four Escalating Dose Regimens of TPI ASM8 in Patients With Allergic Asthma
A Single Center, Open Label, Stepwise, Dose Profiling Study to Evaluate the Efficacy and Safety of Four Dose Regimens of Inhaled TPI ASM8 in Patients With Allergic Asthma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Syntara · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
During this proposed clinical trial, the investigators intend to evaluate the pharmacodynamic anti-inflammatory properties and safety of TPI ASM8, by investigating the effect on sputum eosinophils and the airway responses during an allergen challenge at different dose levels.
Detailed description
The early and late asthmatic response were both significantly attenuated by the highest dose of ASM8. The methacholine challenge and other parameters (ECP, mRNA knockdown on CCR3 and B-Chain of IL-3-Il-5 and GMCSF were attenuated by ASM8.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TPI ASM8 | 4 mg/mL, 1 mg BID for 4 days |
| DRUG | TPI ASM8 | 4 mg/mL, 2 mg BID for 4 days |
| DRUG | TPI ASM8 | 4 mg/mL, 4 mg BID for 4 days |
| DRUG | TPI ASM8 | 4 mg/mL, 8 mg OD for 4 days |
Timeline
- Start date
- 2009-04-01
- Primary completion
- 2010-02-01
- Completion
- 2010-02-01
- First posted
- 2009-01-15
- Last updated
- 2013-11-15
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT00822861. Inclusion in this directory is not an endorsement.