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

NCT ID: NCT01845623

Last Updated: 2017-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment A

Group Type EXPERIMENTAL

QAB149 75 mg Concept 1

Intervention Type DRUG

QAB149 delivered via the concept 1 device.

Placebo EPIC Test Fixture

Intervention Type OTHER

Placebo administered via the EPIC Test Fixture.

Treatment B

Group Type EXPERIMENTAL

QAB149 75 mg Epic Test Fixture

Intervention Type DRUG

QAB149 delivered via the EPIC test fixture

Placebo Concept 1

Intervention Type OTHER

Placebo administered via the Concept 1 device.

Treatment C

Group Type PLACEBO_COMPARATOR

Placebo Concept 1

Intervention Type OTHER

Placebo administered via the Concept 1 device.

Placebo EPIC Test Fixture

Intervention Type OTHER

Placebo administered via the EPIC Test Fixture.

Interventions

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QAB149 75 mg Concept 1

QAB149 delivered via the concept 1 device.

Intervention Type DRUG

QAB149 75 mg Epic Test Fixture

QAB149 delivered via the EPIC test fixture

Intervention Type DRUG

Placebo Concept 1

Placebo administered via the Concept 1 device.

Intervention Type OTHER

Placebo EPIC Test Fixture

Placebo administered via the EPIC Test Fixture.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Other Identifiers

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2011-001824-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CMID001A2201

Identifier Type: -

Identifier Source: org_study_id

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