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

A Randomized, Double-blind, Parallel Group Study to Compare the Pharmacodynamics/Efficacy, Safety and Pharmacokinetics of QAV680 Versus Placebo in Patients With Moderate Persistent Asthma

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01103037
Enrollment
8
Registered
2010-04-13
Start date
2010-03-31
Completion date
2010-09-30
Last updated
2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Mild, Moderate, Asthma

Brief summary

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

Interventions

DRUGQAV680

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

DRUGQAV680 Placebo

Placebo to QAV680 5 capsules four times per day

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Patients with moderate persistent asthma

Exclusion criteria

* Smokers * Any significant disease or illness, other than asthma Other protocol-defined inclusion/

Design outcomes

Primary

MeasureTime frame
Change in Forced Expiratory Volume in one second (FEV1) as measured by Spirometry28 days

Secondary

MeasureTime frame
FEV1 assessments at various timepoints including time of peak drug concentration28 days
Measure the change in exhaled Nitric Oxide (FeNO)28 days
Assessment of the pharmacokinetics of multiple doses of QAV680 in patients with mild to moderate asthma.28 days
Total serum IgE levels28 days
Change in daily variability in the morning and evening Peak Expiratory Flow Rate (PEFR) from Baseline.28 days

Countries

Germany, Russia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026