Clinical trial NCT01253603: Efficacy, Safety, and Pharmacokinetics of QAW039
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Persistent Asthma
Keywords: Asthma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-12-03
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety, efficacy and pharmacokinetics of QAW039 in steroid-free patients with mild to moderate persistent asthma.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Change in trough forced expiratory volume in 1 second (FEV1) compared to placebo.
timeFrame: 28 days
Secondary outcomes:
measure: To assess the safety of a 28 day administration of QAW039 compared to placebo, measured by vital signs, laboratory evaluations and electrocardiograms.
timeFrame: 28 days
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: Novartis Investigative Site
state: California
city: Huntington Beach
country: United States
facility: Novartis Investigative Site
state: California
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Mission Viejo
country: United States
facility: Novartis Investigative Site
state: California
city: San Diego
country: United States
facility: Novartis Investigative Site
state: California
city: San Diego
country: United States
facility: Novartis Investigative Site
state: California
city: San Jose
country: United States
facility: Novartis Investigative Site
state: California
city: Stockton
country: United States
facility: Novartis Investigative Site
state: California
city: Stockbridge
country: United States
facility: Novartis Investigative Site
state: Georgia
city: North Dartmouth
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Bellevue
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Berlin
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Skillman
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Raleigh
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Medford
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Upland
country: United States
facility: Novatis Investigative Site
state: Pennsylvania
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Jambes
country: Belgium
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.