drugset / Trial / NCT03108534

A Study to Evaluate the Onset of Relief From Methacholine-induced Bronchoconstriction With CHF1535 NEXThaler in Asthmatic Patients.

NCT03108534

Phase 2 Completed 65 enrolled Chiesi Farmaceutici S.p.A.
RandomizedCrossoverQuadruple-blindTreatment

Summary

The clinical trial is designed to evaluate the non-inferiority of CHF1535 100/6 µg NEXThaler versus CHF1535 100/6 µg pMDI on the onset of relief from methacholine-induced bronchospasm, in terms of pulmonary function (i.e. change in Forced Expiratory Volume in the 1st second, FEV1, from baseline to 5 min after study drug intake) in asthmatic patients.

Timeline

Start
2017-02-28
Primary completion
2017-09-19
Completion
2017-09-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Formoterol Other / unclassified 6 ug
Subject beclomethasone dipropionate Other / unclassified 100 ug

Indications