NCT00862394

A Study Comparing the Efficacy and Safety of CHF 1535 (BDP +FF) Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (BDP +FF), Administered Via a pMDI, in Moderate to Severe Asthma

A 12-week, Multinational, Randomised, Double Blind, Double Dummy, 4-arm Parallel-group Study Comparing the Efficacy and Safety of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate) 100 + 6 μg/Actuation Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate) 100 + 6 μg/Actuation, Via HFA Pressurised Inhalation Solution, in Moderate to Severe Symptomatic Asthmatic Patients Aged ≥ 12 Years Under Treatment With Inhaled Corticosteroids

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 783 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate that CHF 1535 via NEXT DPI (beclomethasone dipropionate + formoterol fumarate 100 + 6 μg), 1 inhalation or 2 inhalations twice daily, for 12 weeks is non-inferior to the corresponding dose of CHF 1535 via HFA-134a "extrafine" pMDI in terms of pulmonary function in moderate to severe symptomatic asthmatic patients aged ≥ 12 years under treatment with inhaled corticosteroids

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	BDP/Formoterol Next DPI	BDP/Formoterol Next DPI 100/6 µg (daily dose : 200/12 µg)
DRUG	Foster	BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 200/12 µg)
DRUG	BDP/Formoterol Next DPI	BDP/Formoterol 100/6 µg (daily dose : 400/24 µg)
DRUG	Foster	BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 400/24 µg)

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-10-01
• Completion: 2010-01-01
• First posted: 2009-03-16
• Last updated: 2018-04-13

Locations

1 site across 1 country: Germany