SALTO - Symbicort Single Inhaler Therapy Use in Adolescent Adults and Adults With Persistent Asthma

Phase 3 Completed 1000 enrolled AstraZeneca

RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective is to compare the efficacy of Symbicort Single inhaler Therapy with treatment according to conventional best practice in adolescent and adult patients with persistent asthma.

Timeline

Start: 2004-12
Primary completion: —
Completion: 2006-08

Outcome

Missed primary endpoint

paper No difference between groups was seen in time to first severe exacerbation (p = 0.75). PMID 19769705 ↗

paper annual rate 0.07 vs. 0.13 p = 0.09 PMID 19769705 ↗

Publications

Louis R, Joos G, Michils A, Vandenhoven G. A comparison of budesonide/formoterol maintenance and reliever therapy vs. conventional best practice in asthma management. Int J Clin Pract. 2009 Oct;63(10):1479-88. doi: 10.1111/j.1742-1241.2009.02185.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Budesonide	Small molecule	160 ug	Inhaled
Subject	Formoterol	Other / unclassified	4.5 ug	Inhaled