drugset / Trial / NCT01696214
A Pilot Study to Determine the Feasibility and Utility of Implementing of the Full Scale TOM Trial
Phase 4
Completed
20 enrolled
University of California, San Diego
National Heart, Lung, and Blood Institute (NHLBI) · collab
RandomizedFactorialDouble-blindTreatment
Summary
The primary aim of the pilot (SAPS) protocol is to determine the feasibility and utility of implementing the provisional design of the full scale TOM trial (e.g., the six month treatment period, the impact of the smoking cessation intervention). There is no active hypothesis for the Vanguard Protocol.
Timeline
- Start
- 2012-10
- Primary completion
- 2015-05
- Completion
- 2016-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fluticasone | Other / unclassified | 250 mg | Inhaled |
| Comparator | Ipratropium | Small molecule | 0.02 % | Inhaled |
| Comparator | Ipratropium | Small molecule | 2.5 ml | Inhaled |
| Comparator | Montelukast | Other / unclassified | 10 mg | — |
| Comparator | Salmeterol | Other / unclassified | 50 mg | Inhaled |
| Comparator | Theophylline | Small molecule | 400 mg | — |