Effects on Small Airways of Two Long-term Extrafine Treatments in Asthma (FORTINO)
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.
|Bronchial Asthma||Drug: Salmeterol Fluticasone Drug: formoterol - beclometasone||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Effects on Small Airways Obstruction of Two Long-term Treatments With Extrafine Beclomethasone/Formoterol vs Fluticasone/Salmeterol in Asthma|
- Small airways obstruction [ Time Frame: 24 weeks ]
|Study Start Date:||July 2007|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Active Comparator: SF
Drug: Salmeterol Fluticasone
salmeterol 50 mcg and fluticasone 250 mcg (diskus) b.i.d.
Other Name: SERETIDE
Active Comparator: FB
Extrafine Formoterol and beclometasone HFA
Drug: formoterol - beclometasone
formoterol 12 mcg and beclometasone 200 mcg HFA (by MDI) b.i.d.
Other Name: FOSTER
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01255579
|Study Chair:||Claudio Tantucci, MD||Università degli Studi di Brescia|