Efficacy, Safety, and Pharmacokinetics of QAW039
A Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Pharmacokinetics of QAW039 in Steroid-free Patients With Mild to Moderate Persistent Asthma
2 other identifiers
interventional
170
5 countries
26
Brief Summary
This study will assess the safety, efficacy and pharmacokinetics of QAW039 in steroid-free patients with mild to moderate persistent asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2010
Shorter than P25 for phase_2
26 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
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 1, 2010
CompletedFirst Posted
Study publicly available on registry
December 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedDecember 19, 2020
August 1, 2013
10 months
December 1, 2010
December 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in trough forced expiratory volume in 1 second (FEV1) compared to placebo.
28 days
Secondary Outcomes (1)
To assess the safety of a 28 day administration of QAW039 compared to placebo, measured by vital signs, laboratory evaluations and electrocardiograms.
28 days
Study Arms (3)
1
EXPERIMENTALQAW039 capsules once daily for 28 days
2
EXPERIMENTALPlacebo to QAW039 capsules once daily for 28 days
3
EXPERIMENTALFluticasone propionate inhaler twice daily for 28 days
Interventions
Eligibility Criteria
You may qualify if:
- Patients with a medical history of mild to moderate persistent allergic asthma.
- Patients must weigh at least 45 kg to participate in the study, and must have abody mass index (BMI) of \>17 kg/m2.
- Female patients must be surgically sterilized, postmenopausal or using a double-barrier method of contraception
You may not qualify if:
- Women of child-bearing potential.
- Smokers defined as history of smoking in the previous 6 months or a smoking history of more than 10 pack years, a pack year being defined as smoking the equivalent of 20 cigarettes - a pack - every day for the period of 1 year
- Patients with severe persistent asthma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Novartis Investigative Site
Encinitas, California, 92024, United States
Novartis Investigative Site
Huntington Beach, California, 92647, United States
Novartis Investigative Site
Los Angeles, California, 90025, United States
Novartis Investigative Site
Los Angeles, California, 90048, United States
Novartis Investigative Site
Mission Viejo, California, 92691, United States
Novartis Investigative Site
San Diego, California, 92120, United States
Novartis Investigative Site
San Diego, California, 92123, United States
Novartis Investigative Site
San Jose, California, 95117, United States
Novartis Investigative Site
Stockton, California, 95207, United States
Novartis Investigative Site
Stockbridge, Georgia, 30281, United States
Novartis Investigative Site
North Dartmouth, Massachusetts, 02747, United States
Novartis Investigative Site
Bellevue, Nebraska, 68123, United States
Novartis Investigative Site
Berlin, New Jersey, 08009, United States
Novartis Investigative Site
Skillman, New Jersey, 08558, United States
Novartis Investigative Site
Raleigh, North Carolina, 27607, United States
Novartis Investigative Site
Medford, Oregon, 97504, United States
Novatis Investigative Site
Upland, Pennsylvania, 19013, United States
Novartis Investigative Site
Dallas, Texas, 75231, United States
Novartis Investigative Site
Jambes, Belgium
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Cologne, Germany
Novartis Investigative Site
Frankfurt, Germany
Novartis Investigative Site
Hamburg, Germany
Novartis Investigative Site
Wiesbaden, Germany
Novartis Investigative Site
Bucharest, Romania
Novartis Investigative Site
Seoul, South Korea
Related Publications (1)
Erpenbeck VJ, Popov TA, Miller D, Weinstein SF, Spector S, Magnusson B, Osuntokun W, Goldsmith P, Weiss M, Beier J. The oral CRTh2 antagonist QAW039 (fevipiprant): A phase II study in uncontrolled allergic asthma. Pulm Pharmacol Ther. 2016 Aug;39:54-63. doi: 10.1016/j.pupt.2016.06.005. Epub 2016 Jun 21.
PMID: 27354118DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition 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
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2010
First Posted
December 3, 2010
Study Start
November 1, 2010
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
December 19, 2020
Record last verified: 2013-08