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Efficacy, Safety and Pharmacokinetics of QAV680 in Asthma Patients

This study has been completed.
Information provided by:
Novartis Identifier:
First received: December 23, 2008
Last updated: March 6, 2017
Last verified: February 2017
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 Intervention Phase
Asthma Drug: QAV680 Drug: Matching placebo for QAV680 Drug: Fluticasone Propionate Phase 2

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by Novartis:

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

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

Enrollment: 37
Study Start Date: December 2008
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QAV680 Drug: QAV680
Placebo Comparator: Placebo Drug: Matching placebo for QAV680
Active Comparator: Fluticasone Propionate Inhaler Drug: Fluticasone Propionate


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

  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: 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
  More Information

Additional Information:
Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT00814216     History of Changes
Other Study ID Numbers: CQAV680A2201
EudraCT number: 2008-005168-15
Study First Received: December 23, 2008
Last Updated: March 6, 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 processed this record on September 20, 2017