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

This study has been terminated.
(Terminated by sponsor)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01103037
First received: April 12, 2010
Last updated: May 2, 2012
Last verified: May 2012
History of Changes
  Purpose

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 (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in Forced Expiratory Volume in one second (FEV1) as measured by Spirometry [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FEV1 assessments at various timepoints including time of peak drug concentration [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Measure the change in exhaled Nitric Oxide (FeNO) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Assessment of the pharmacokinetics of multiple doses of QAV680 in patients with mild to moderate asthma. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Total serum IgE levels [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Change in daily variability in the morning and evening Peak Expiratory Flow Rate (PEFR) from Baseline. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103037

Locations
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
Germany
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
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01103037     History of Changes
Other Study ID Numbers: CQAV680A2201E1, 2009-017267-41
Study First Received: April 12, 2010
Last Updated: May 2, 2012
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Russia: Pharmacological Committee, Ministry of Health

Keywords provided by Novartis:
Mild
Moderate
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on June 17, 2013