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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.
Details
| Lead sponsor | University of California, San Diego |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 20 |
| Start date | 2012-10 |
| Completion | 2016-11 |
Conditions
- Asthma
Interventions
- Fluticasone 250 mg/salmeterol 50 mg
- Montelukast 10mg
- Theophylline 400 mg
- ipratropium
Primary outcomes
- Asthma Control Test — Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks and at follow-up visit 1 month off study drug. Median scores over the 24 weeks of treatment were compared.
The primary symptomatic measure, the Asthma Control Test (ACT), has been shown to be valid for measuring poor asthma control in asthmatic children and non-smoking adults. The ACT is a tool developed by Nathan and collaborators a decade ago for evaluating asthma control. It consists of five questions with five possible answers each. A maximum score of 25 points indicates complete asthma control. A score between 20 and 24 represents partially controlled asthma, while a score 19 or below indicates poorly controlled asthma and a score \<16 indicates uncontrolled asthma. The minimally important clinical difference has been determined to be 3.
Countries
United States