Effects on Small Airways of Two Long-term Extrafine Treatments in Asthma (FORTINO)
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|ClinicalTrials.gov Identifier: NCT01255579|
Recruitment Status : Completed
First Posted : December 7, 2010
Last Update Posted : December 7, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Bronchial Asthma||Drug: Salmeterol Fluticasone Drug: formoterol - beclometasone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effects on Small Airways Obstruction of Two Long-term Treatments With Extrafine Beclomethasone/Formoterol vs Fluticasone/Salmeterol in Asthma|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||December 2008|
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
- Small airways obstruction [ Time Frame: 24 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01255579
|Study Chair:||Claudio Tantucci, MD||Università degli Studi di Brescia|