Efficacy, Safety and Pharmacokinetics of QAV680 in Asthma Patients

Novartis

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Fluticasone Propionate; Drug: Matching placebo for QAV680; Drug: QAV680

Study type: Interventional

Funder types: Industry

Identifiers

NCT00814216

CQAV680A2201

EudraCT number: 2008-005168-15

Details and patient eligibility

About

This study aims to study the efficacy (as measured by change in FEV1) and safety of two-week administration of oral QAV680 in the treatment of patients with asthma.'

Enrollment: 37 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mild to moderate persistent asthma for at least 6 months.

Exclusion criteria

• Past or recent history of significant medical illness and/or lab abnormalities including but not limited to ECG abnormalities, abnormal LFT, HIV, Hep B/C,
• Allergic disorders, pancreatic disease, serious underlying respiratory diseases, life threatening asthma, renal disease etc
• Surgical and/or medical conditions which significantly effect ADME of the drug.
• Prior use of asthma medications (except SABA's) prior to 2 weeks of dosing

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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37 participants in 3 patient groups, including a placebo group

QAV680

Experimental group

Treatment:

Drug: QAV680

Placebo

Placebo Comparator group

Treatment:

Drug: Matching placebo for QAV680

Fluticasone Propionate Inhaler

Active Comparator group

Treatment:

Drug: Fluticasone Propionate