Trials / Completed
CompletedNCT00327808
Inhaled TPI-1020 Versus Inhaled Budesonide in Smokers With Mild Reversible Asthma
Multi-Center, Randomized, Double-Blind, Repeated Doses Study to Evaluate the Safety, Tolerability and Pharmacodynamic Activity of Inhaled TPI-1020 Versus Inhaled Budesonide in Smokers With Mild Reversible Asthma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- Syntara · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The investigators will look at TPI-1020 safety and tolerability in mild to moderate asthmatic smoker subjects.
Detailed description
This study will assess and compare the safety and tolerability of inhaled TPI 1020 versus budesonide. Pharmacokinetic (PK) and pharmacodynamic (PD) parameters will also be studied in a sub-group of subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TPI-1020 | 600 mcg BID x 14 days followed by 1200 mcg BID x 7 days |
| DRUG | budesonide | 400 mcg BID x 14 days then 800 mcg/day x 7 more days |
Timeline
- Start date
- 2006-05-01
- Primary completion
- 2007-03-01
- Completion
- 2007-03-01
- First posted
- 2006-05-19
- Last updated
- 2012-12-03
Locations
7 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT00327808. Inclusion in this directory is not an endorsement.