Efficacy, Safety and Pharmacokinetics of QAV680 in Asthma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00814216
Recruitment Status : Completed
First Posted : December 24, 2008
Last Update Posted : March 8, 2017
Information provided by:

Brief Summary:
This study aims to study the efficacy (as measured by change in FEV1) and safety of two-week administration of oral QAV680 in the treatment of patients with asthma.`

Condition or disease Intervention/treatment Phase
Asthma Drug: QAV680 Drug: Matching placebo for QAV680 Drug: Fluticasone Propionate Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Two Way Cross-over, Proof of Concept Study to Compare Efficacy, Safety, Pharmacokinetics & Pharmacodynamics of QAV680 Versus Placebo, With an Extended Open-label Corticosteroid Period, in Steroid-free, Mild to Moderate Persistent Asthma Patients.
Study Start Date : December 2008
Actual Primary Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Fluticasone
U.S. FDA Resources

Arm Intervention/treatment
Experimental: QAV680 Drug: QAV680
Placebo Comparator: Placebo Drug: Matching placebo for QAV680
Active Comparator: Fluticasone Propionate Inhaler Drug: Fluticasone Propionate

Primary Outcome Measures :
  1. Measure: Change in Forced Expiratory Volume in one second (FEV1) as measured by Spirometry. [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Measure: Change in Asthma Control Questionnaire (ACQ) score [ Time Frame: 2 weeks ]
  2. Measure: Frequency of salbutamol usage [ Time Frame: 2 weeks ]
  3. Measure: Change in exhaled Nitric Oxide (NO) [ Time Frame: 2 weeks ]
  4. Home Monitoring Of FEV1 By PIKO Monitors [ Time Frame: Day 2 to Day 13 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Mild to moderate persistent asthma for at least 6 months.

Exclusion criteria:

  • Past or recent history of significant medical illness and/or lab abnormalities including but not limited to ECG abnormalities, abnormal LFT, HIV, Hep B/C,
  • Allergic disorders, pancreatic disease, serious underlying respiratory diseases, life threatening asthma, renal disease etc
  • Surgical and/or medical conditions which significantly effect ADME of the drug.
  • Prior use of asthma medications (except SABA's) prior to 2 weeks of dosing

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 identifier (NCT number): NCT00814216

Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Munich, Germany
Novartis Investigative Site
Wiesbaden, Germany
Novartis Investigative Site
Ahmedabad, India
Novartis Investigative Site
Mumbai, India
Novartis Investigative Site
Mysore, India
Novartis Investigative SIte
Nagpur, India
Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT00814216     History of Changes
Other Study ID Numbers: CQAV680A2201
EudraCT number: 2008-005168-15
First Posted: December 24, 2008    Key Record Dates
Last Update Posted: March 8, 2017
Last Verified: February 2017

Keywords provided by Novartis:

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents