drugset / Trial / NCT01741285
Effects of QVAR in Smokers With Asthma
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Beclomethasone | Small molecule | 200 ug | Inhaled |
| Comparator | Beclomethasone | Small molecule | 400 ug | Inhaled |
| Subject | Fluticasone | Other / unclassified | 250 ug | Inhaled |