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

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ClinicalTrials.gov Identifier: NCT01103037
Recruitment Status : Terminated (Terminated by sponsor)
First Posted : April 13, 2010
Last Update Posted : May 4, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Asthma Drug: QAV680 Drug: QAV680 Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : March 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
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



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

Secondary Outcome Measures :
  1. FEV1 assessments at various timepoints including time of peak drug concentration [ Time Frame: 28 days ]
  2. Measure the change in exhaled Nitric Oxide (FeNO) [ Time Frame: 28 days ]
  3. Assessment of the pharmacokinetics of multiple doses of QAV680 in patients with mild to moderate asthma. [ Time Frame: 28 days ]
  4. Total serum IgE levels [ Time Frame: 28 days ]
  5. Change in daily variability in the morning and evening Peak Expiratory Flow Rate (PEFR) from Baseline. [ Time Frame: 28 days ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01103037     History of Changes
Other Study ID Numbers: CQAV680A2201E1
2009-017267-41 ( EudraCT Number )
First Posted: April 13, 2010    Key Record Dates
Last Update Posted: May 4, 2012
Last Verified: May 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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