NCT02693769

A Study to Compare Fluticasone /Formoterol Breath Actuated Inhaler (BAI) and Ultibro in Subjects With Fixed Airflow Obstruction and Elevated Eosinophils

A Randomised, Single Blind, Cross-over Study to Compare a Fixed Dose Combination of Fluticasone Propionate / Formoterol Fumarate (Breath Actuated Inhaler (BAI)) With a Fixed Dose Combination of Indacaterol Maleate / Glycopyrronium Bromide (Ultibro® Breezhaler) in Subjects With Fixed Airflow Obstruction and Elevated Eosinophils

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Mundipharma Research Limited · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate whether fluticasone/formoterol Breath actuated inhaler is effective and well tolerated in the treatment of subjects with fixed airflow obstruction and elevated eosinophils.

Detailed description

The study is designed to provide efficacy and safety data for the use of fluticasone/formoterol Breath actuated inhaler in subjects with the characteristics of fixed airflow obstruction and elevated eosinophils. These patients have typically been excluded from previous Flutiform pMDI asthma and chronic obstructive pulmonary disease (COPD) trials; for example in asthma studies, patients with a smoking history of 10 pack years or more have been excluded, conversely in COPD studies patients with any prior history of asthma have been excluded. It is expected that the data from this study will provide a greater understanding of the effects of fluticasone/formoterol in this patient population

Conditions

• ACOS (Fixed Airflow Obstruction and Elevated Eosinophils)

Interventions

Type	Name	Description
DRUG	fluticasone propionate/formoterol fumarate breath actuated inhaler
DRUG	Indacaterol maleate / glycopyrronium bromide capsules

Timeline

• Start date: 2016-07-01
• Primary completion: 2016-10-01
• Completion: 2016-12-01
• First posted: 2016-02-29
• Last updated: 2016-12-12

Locations

1 site across 1 country: Slovakia