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

This study has been terminated.
(Terminated by sponsor)
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: April 12, 2010
Last updated: May 2, 2012
Last verified: May 2012
This study will assess the safety and efficacy of QAV680 in patients with mild to moderate asthma

Condition Intervention Phase
Asthma Drug: QAV680 Drug: QAV680 Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Change in Forced Expiratory Volume in one second (FEV1) as measured by Spirometry [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 8
Study Start Date: March 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QAV680 Drug: QAV680
QAV680 500 mg (5 x 100 mg capsules) four times per day
Placebo Comparator: QAV680 Placebo Drug: QAV680 Placebo
Placebo to QAV680 5 capsules four times per day


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01103037

United States, California
West Coast Clinical Trials
Cypress, California, United States, 90630
United States, North Carolina
American Health Research
Charlotte, North Carolina, United States, 28207
North Carolina Clinical Research
Raleigh, North Carolina, United States, 27607
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Hamburg, Germany
Novartis Investigative Site
Wiesbaden, Germany
Russian Federation
Novartis Investigative Site
Moscow, Russian Federation
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01103037     History of Changes
Other Study ID Numbers: CQAV680A2201E1
2009-017267-41 ( EudraCT Number )
Study First Received: April 12, 2010
Last Updated: May 2, 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases processed this record on July 19, 2017