NCT02148120

A Study to Evaluate the Acute Bronchodilator Effect of CHF1535 NEXThaler

A Phase II, Multicentre, Double-blind, Randomised, 5-way Crossover Study to Test the Non-inferiority of the Acute Bronchodilator Effect of CHF 1535 200/6 µg NEXThaler Versus CHF 1535 100/6 µg NEXThaler in Partially Controlled and Uncontrolled Adult Asthmatic Patients.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to demonstrate the non-inferiority in terms of acute bronchodilator effect between a single dose of CHF 1535 NEXThaler 200/6 µg and a single dose of CHF 1535 NEXThaler 100/6 µg at two dose levels in partially controlled and uncontrolled asthmatic patients.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg
DRUG	Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg
DRUG	Placebo

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-05-28
• Last updated: 2017-03-29

Locations

3 sites across 1 country: United Kingdom