drugset / Trial / NCT01741285

Effects of QVAR in Smokers With Asthma

NCT01741285

RandomizedCrossoverOpen-labelTreatment

Summary

We hypothesize that extra-fine particle treatment with HFA-QVAR will be superior in improving small airways dysfunction, especially in ex-smokers and smokers with asthma. To investigate this, we will perform a study comparing the efficacy of extra-fine particle HFA-QVAR 200 µg b.i.d. to an equipotent dose of course particle HFA-beclomethasone (HFA-Clenil) 400 µg b.i.d. and with coarse particle HFA-fluticasone (GSK) 250 µg in ex-smokers and smokers with asthma. Study design: This study will be an open-label, randomised, three-way cross-over, two-center study. 20 smokers and 20 ex-smokers with asthma will receive the following treatments for two weeks:

Timeline

Start
2013-04
Primary completion
2015-07
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Beclomethasone Small molecule 200 ug Inhaled
Comparator Beclomethasone Small molecule 400 ug Inhaled
Subject Fluticasone Other / unclassified 250 ug Inhaled

Indications