CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Fluticasone 250 mg/salmeterol 50 mg +3 moredrug
Likely dose
Fluticasone 250 mg/salmeterol 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01696214
NCT01696214Phase 4Completed
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SAPS:Smoking Asthmatics Pilot Study:

University of California, San Diego·interventional·Posted Sep 28, 2012·Updated Jan 23, 2019

In Brief

A Phase 4 clinical trial evaluating Fluticasone 250 mg/salmeterol 50 mg, Montelukast 10mg, and 2 other interventions for Asthma. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 28, 2012
Enrollment StartOct 1, 2012
Primary CompletionMay 1, 2015
Study CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 13.8 years ago

Interventions

Fluticasone 250 mg/salmeterol 50 mgdrug

Drug: Fluticasone 250 mg/salmeterol 50 mg Participants will be assigned to a 24 week treatment with inhaled fluticasone/salmeterol or matching placebo

Montelukast 10mgdrug

Participants will be assigned to montelukast once a day for 24 weeks.

Theophylline 400 mgdrug

Participants will be assigned to theophylline once a day for 24 weeks

ipratropiumdrug

Participants will be assigned to ipratropium 2.5 mL of 0.02% solution via mini nebulizer 3 times a day day for 24 weeks.