NCT00868023

Next DPI LABA, Multicentre, 5-way Cross-over, Adult Asthmatic Patients

A Phase II, Multinational, Multicentre, Double Blind, Double Dummy, Randomised, 5-way Cross-over, Placebo and Active Controlled Clinical Study to Test the Non-inferiority of a Single Dose of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate 100 µg Plus Formoterol Fumarate 6 µg Dry Powder) Via NEXT™ DPI 1 or 4 Inhalations Versus CHF 1535 (Beclomethasone Dipropionate 100 µg Plus Formoterol Fumarate 6 µg) pMDI With HFA-134a Propellant 1 or 4 Puffs on FEV1 AUC0-12h in Partly Controlled Adult Asthmatic Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multinational, multicentre, randomised, double blind, double dummy, placebo and active controlled, 5-way cross over

Detailed description

To demonstrate the non-inferiority in terms of FEV1 AUC0-12h between a single dose of CHF 1535 via NEXT DPI and CHF 1535 via HFA-134a "extrafine" pMDI in partly controlled adult asthmatic patients

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	CHF 1535 Next DPI	CHF 1535 DPI : BDP/Formoterol : 100/6 µg (daily dose : BDP/Formoterol : 400/24 µg)
DRUG	Foster BDP/Formoterol	BDP/Formoterol 100/6 µg (daily dose : BDP/Formoterol : 400/24 µg)
DRUG	CHF 1535 Next DPI	CHF 1535 DPI : BDP/Formoterol : 100/6 µg (daily dose : BDP/Formoterol : 100/6 µg)
DRUG	Foster BDP/Formoterol	BDP/Formoterol 100/6 µg (daily dose : BDP/Formoterol : 100/6 µg
DRUG	Placebo	Placebo

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-07-01
• Completion: 2009-10-01
• First posted: 2009-03-24
• Last updated: 2017-03-30

Locations

1 site across 1 country: United Kingdom