drugset / Trial / NCT01255579

Effects on Small Airways of Two Long-term Extrafine Treatments in Asthma

NCT01255579

Phase 4 Completed 10 enrolled University of Brescia
RandomizedCrossoverDouble-blindTreatment

Summary

New formulations of extrafine particles of long acting beta-2 agonists+inhaled corticosteroids (LABA+ICS) are able to reach more peripheral regions of the lung. Objectives.The aim of this study was to assess the effect on small airways obstruction of long-term treatments with two different LABA+ICS combinations in asthma. Patients and methods.Ten subjects with moderate persistent asthma were enrolled. After a 4-week washout they were treated in a randomized cross-over design for 24 weeks with formoterol 12 mcg and beclometasone 200 mcg HFA (by MDI) b.i.d. (FB) or salmeterol 50 mcg and fluticasone 250 mcg (diskus) b.i.d. (SF). At baseline and at the end of each period subjects underwent Asthma Control Test (ACT) and Pulmonary Function Testing. The N2 phase III slope and closing volume (CV) during single breath washout test, and DElta(Heliox-air)MEF50% were measured to assess changes on peripheral airways function.

Timeline

Start
2007-07
Primary completion
2008-12
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Beclomethasone Small molecule 200 ug Inhaled
Comparator Fluticasone Other / unclassified 250 ug Inhaled
Comparator Formoterol Other / unclassified 12 ug Inhaled
Comparator Salmeterol Other / unclassified 50 ug Inhaled

Indications