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NCT01103037 Clinical Trial

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

Asthma Clinical Trial

Official title:
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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01103037
Other study ID # CQAV680A2201E1
Secondary ID 2009-017267-41
Status Terminated
Phase Phase 2
First received
Last updated
Start date March 2010
Est. completion date September 2010

Study information
Verified date May 2012
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 8
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• QAV680
QAV680 500 mg (5 x 100 mg capsules) four times per day
• QAV680 Placebo
Placebo to QAV680 5 capsules four times per day

Locations
Country Name City State
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Wiesbaden
Russian Federation Novartis Investigative Site Moscow
United States American Health Research Charlotte North Carolina
United States West Coast Clinical Trials Cypress California
United States North Carolina Clinical Research Raleigh North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Germany,  Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Forced Expiratory Volume in one second (FEV1) as measured by Spirometry 28 days
Secondary FEV1 assessments at various timepoints including time of peak drug concentration 28 days
Secondary Measure the change in exhaled Nitric Oxide (FeNO) 28 days
Secondary Assessment of the pharmacokinetics of multiple doses of QAV680 in patients with mild to moderate asthma. 28 days
Secondary Total serum IgE levels 28 days
Secondary Change in daily variability in the morning and evening Peak Expiratory Flow Rate (PEFR) from Baseline. 28 days
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