Phase 2Completed
Safety, Tolerability and PD Activity of Inhaled TPI 1020 Versus Inhaled Budesonide in COPD Patients
Multi-Center, Randomized, Double-Blind, Placebo and Active-Controlled, 6-week Study to Evaluate the Safety, Tolerability and Pharmacodynamic Activity of Inhaled TPI 1020 in COPD Patients.
- Sponsor
- Syntara (Industry)
- Enrolment
- 62 enrolled
- Conditions
- Copd Bronchitis
- Interventions
- TPI 1020; Budesonide; Placebo
- Ages
- adults, older adults
- Registry
- NCT00483743
Full record on ClinicalTrials.gov
From the registry
This study will assess and compare the safety and tolerability of inhaled TPI 1020 (repeated nominal doses; 500 μg BID x 6 weeks) versus inhaled budesonide (repeated doses; 800 μg BID x 6 weeks) and a matching placebo. Pharmacodynamic (PD) activity on FEV1, sputum and blood cells and cytokines will also be studied.
Primary outcomes
- To determine the airway specific, and general safety and the tolerability of inhaled TPI 1020 administered via Aerolizer™ in COPD patients. • To assess the effects of TPI 1020 versus those of budesonide on sputum neutrophil counts on Days 0 and 42.
History
Last registry update
Primary completion
Started
Registered