drugset / Trial / NCT02148120

A Study to Evaluate the Acute Bronchodilator Effect of CHF1535 NEXThaler

NCT02148120

Phase 2 Completed 60 enrolled Chiesi Farmaceutici S.p.A.
RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2014-04
Primary completion
2014-10
Completion
2014-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Formoterol Other / unclassified 6 ug
Subject Formoterol Other / unclassified 24 ug
Subject beclomethasone dipropionate Other / unclassified 100 ug
Subject beclomethasone dipropionate Other / unclassified 200 ug
Subject beclomethasone dipropionate Other / unclassified 400 ug
Subject beclomethasone dipropionate Other / unclassified 800 ug

Indications