Efficacy, Safety and Pharmacokinetics of QAV680 Versus Placebo in Patients With Asthma

Phase 2TerminatedNCT01103037

Novartis Pharmaceuticals8 enrolled

Overview

This study will assess the safety and efficacy of QAV680 in patients with mild to moderate asthma

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Asthma

Interventions

QAV680DRUG

QAV680 500 mg (5 x 100 mg capsules) four times per day

QAV680 PlaceboDRUG

Placebo to QAV680 5 capsules four times per day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with moderate persistent asthma Exclusion Criteria: * Smokers * Any significant disease or illness, other than asthma Other protocol-defined inclusion/exclusion criteria may apply

Locations (7)

West Coast Clinical Trials

Cypress, California, United States

American Health Research

Charlotte, North Carolina, United States

North Carolina Clinical Research

Raleigh, North Carolina, United States

Novartis Investigative Site

Berlin, Germany

Outcomes

Primary Outcomes

Change in Forced Expiratory Volume in one second (FEV1) as measured by Spirometry

Time frame: 28 days

Secondary Outcomes

FEV1 assessments at various timepoints including time of peak drug concentration

Time frame: 28 days

Measure the change in exhaled Nitric Oxide (FeNO)

Time frame: 28 days

Assessment of the pharmacokinetics of multiple doses of QAV680 in patients with mild to moderate asthma.

Time frame: 28 days

Total serum IgE levels

Time frame: 28 days

Change in daily variability in the morning and evening Peak Expiratory Flow Rate (PEFR) from Baseline.

Time frame: 28 days

Data from ClinicalTrials.gov

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