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A 12-week, Multicenter, Randomized, Double-blind, Double-dummy, 2-arm Parallel Group Study Comparing the Efficacy and Safety of Foster® NEXThaler® (Beclomethasone Dipropionate 100 µg Plus Formoterol 6 µg/Actuation), 2 Inhalations b.i.d., Versus Seretide® Accuhaler® (Fluticasone 250 µg Plus Salmeterol 50 µg/Actuation), 1 Inhalation b.i.d., on Small Airway Derived Parameters in Patients With Asthma (NELSON)
The purpose of the present study is to demonstrate the higher efficacy of Foster® NEXThaler® 100/6 extra fine (two inhalations b.i.d.) versus Seretide® Accuhaler® 250/50 (one inhalation b.i.d.), in terms of pulmonary function (change from baseline to the end of treatment in post-dose peripheral airway resistance) in patients with asthma.
Details
| Lead sponsor | Chiesi Farmaceutici S.p.A. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 108 |
| Start date | 2012-07 |
| Completion | 2014-02 |
Conditions
- Asthma
Interventions
- Foster® NEXThaler® 100/6 µg/unit dose
- Seretide® Accuhaler® 250/50 µg/actuation
Primary outcomes
- Change from baseline to end of treatment in post-dose peripheral airway resistance [R(5Hz)-R(20Hz)]. — Baseline and 3 months
Countries
Italy