- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01103037
Efficacy, Safety and Pharmacokinetics of QAV680 Versus Placebo in Patients With Asthma
December 11, 2020 updated by: Novartis Pharmaceuticals
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
This study will assess the safety and efficacy of QAV680 in patients with mild to moderate asthma
Study Overview
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berlin, Germany
- Novartis Investigative Site
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Hamburg, Germany
- Novartis Investigative Site
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Wiesbaden, Germany
- Novartis Investigative Site
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Moscow, Russian Federation
- Novartis Investigative Site
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California
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Cypress, California, United States, 90630
- West Coast Clinical Trials
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North Carolina
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Charlotte, North Carolina, United States, 28207
- American Health Research
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Raleigh, North Carolina, United States, 27607
- North Carolina Clinical Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: QAV680
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QAV680 500 mg (5 x 100 mg capsules) four times per day
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Placebo Comparator: QAV680 Placebo
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Placebo to QAV680 5 capsules four times per day
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Forced Expiratory Volume in one second (FEV1) as measured by Spirometry
Time Frame: 28 days
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28 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
FEV1 assessments at various timepoints including time of peak drug concentration
Time Frame: 28 days
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28 days
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Measure the change in exhaled Nitric Oxide (FeNO)
Time Frame: 28 days
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28 days
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Assessment of the pharmacokinetics of multiple doses of QAV680 in patients with mild to moderate asthma.
Time Frame: 28 days
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28 days
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Total serum IgE levels
Time Frame: 28 days
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28 days
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Change in daily variability in the morning and evening Peak Expiratory Flow Rate (PEFR) from Baseline.
Time Frame: 28 days
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28 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
April 12, 2010
First Submitted That Met QC Criteria
April 12, 2010
First Posted (Estimate)
April 13, 2010
Study Record Updates
Last Update Posted (Actual)
December 19, 2020
Last Update Submitted That Met QC Criteria
December 11, 2020
Last Verified
May 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CQAV680A2201E1
- 2009-017267-41 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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