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Clinical Trial 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.


Clinical Trial Description

The protocol is a small scale pilot of the full-scale TOM trial, and it will utilize a placebo design and incorporates 4 treatment arms. In the Vanguard Protocol all participants are to complete a 4 week run-in with Advair 100/50, followed by randomization to 1 of 4 arms of study treatment. The 4 drug treatment combinations are (2 inhalers, 2 pills):

- Advair 250/50, Placebo, Placebo, Placebo

- Advair 100/50 and montelukast, Placebo, Placebo

- Advair 100/50 and theophylline, Placebo, Placebo

- Advair 100/50 and ipratropium, Placebo, Placebo The 24 week treatment phase will be followed by a 4 week washout period on Advair 100/50. There is no crossover. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01696214
Study type Interventional
Source University of California, San Diego
Contact
Status Completed
Phase Phase 4
Start date October 2012
Completion date November 2016

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