Asthma Clinical Trial
Official title:
SAPS:Smoking Asthmatics Pilot Study:
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.
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.
;
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