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

Novartis

Status and phase: Withdrawn; Phase 2

Conditions: Asthma

Treatments: Other: Placebo Concept 1; Drug: QAB149 75 mg Concept 1; Drug: QAB149 75 mg Epic Test Fixture; Other: Placebo EPIC Test Fixture

Study type: Interventional

Funder types: Industry

Identifiers

NCT01845623

2011-001824-39 (EudraCT Number)

CMID001A2201

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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0 participants in 3 patient groups, including a placebo group

Treatment A

Experimental group

Treatment:

Other: Placebo EPIC Test Fixture

Drug: QAB149 75 mg Concept 1

Treatment B

Experimental group

Treatment:

Other: Placebo Concept 1

Drug: QAB149 75 mg Epic Test Fixture

Treatment C

Placebo Comparator group

Treatment:

Other: Placebo Concept 1

Other: Placebo EPIC Test Fixture