Efficacy, Safety and Pharmacokinetics of QAV680 in Asthma Patients
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.
2 other identifiers
interventional
37
2 countries
7
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.'
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 asthma
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 23, 2008
CompletedFirst Posted
Study publicly available on registry
December 24, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedMarch 8, 2017
February 1, 2017
10 months
December 23, 2008
March 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure: Change in Forced Expiratory Volume in one second (FEV1) as measured by Spirometry.
2 weeks
Secondary Outcomes (4)
Measure: Change in Asthma Control Questionnaire (ACQ) score
2 weeks
Measure: Frequency of salbutamol usage
2 weeks
Measure: Change in exhaled Nitric Oxide (NO)
2 weeks
Home Monitoring Of FEV1 By PIKO Monitors
Day 2 to Day 13
Study Arms (3)
QAV680
EXPERIMENTALPlacebo
PLACEBO COMPARATORFluticasone Propionate Inhaler
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Mild to moderate persistent asthma for at least 6 months.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (7)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 23, 2008
First Posted
December 24, 2008
Study Start
December 1, 2008
Primary Completion
October 1, 2009
Last Updated
March 8, 2017
Record last verified: 2017-02