Overview

A Study to Evaluate the Effects of Indacaterol Maleate (QAB149) as a New Formulation in the EPIC Test Fixture

Status:
Withdrawn
Trial end date:
2013-12-01
Target enrollment:
0
Participant gender:
All
Summary
This study will assess the pharmacodynamics, safety, tolerability and pharmacokinetics of indacaterol maleate (QAB149), administered via the EPIC test fixture. The study aims to determine whether the novel device has a similar clinical profile as the established concept 1 device.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Criteria
Inclusion Criteria:

Male and female patients with asthma, aged 18 or above Patients using inhaled
corticosteroid (with or without long acting beta agonist) Patients who demonstrate an
increase in FEV1 after inhaling a short acting beta agonist

Exclusion Criteria:

Asthma exacerbations in previous 6 months COPD or other pulmonary disease Excessive use of
short acting beta agonists

Other protocol-defined inclusion/exclusion criteria may apply