A Study to Assess the Effect of QAW039 in Non-atopic Asthmatic Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

The purpose of the study was to assess the clinical effect of QAW039 in non-atopic asthmatics taking low dose Inhaled Corticosteroid (ICS) as background therapy.

Key facts

Study ID

NCT01836471

Run by

Novartis Pharmaceuticals

People needed

345

Starts

2013-05-01

Expected to finish

2016-02-01

Last updated by the study team

2017-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent must be obtained before any assessment is performed
• Patients with a diagnosis of persistent asthma (according to Global Initiative for Asthma 2011) for a period of at least 6 months prior to screening
• Patients with a pre-bronchodilator Forced Expiratory Volume In One Second (FEV1) value of 40% to 80% of individual predicted value at screening and prior to treatment
• An Asthma Control Questionnaire score ≥ 1.5 prior to treatment
• Demonstration of reversible airway obstruction

You may not qualify if…

• Pregnant or nursing (lactating) women
• Acute illness other than asthma at the start of the study
• Patients with clinically significant laboratory abnormalities at screening
• Patients with clinically significant condition which may compromise subject safety or interfere with study evaluation
• Use of other investigational drugs at the time of enrollment

Where it is running

• Novartis Investigative Site — Huntington Beach, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Mission Viejo, California, United States
• Novartis Investigative Site — Orange, California, United States
• Novartis Investigative Site — Palmdale, California, United States
• Novartis Investigative Site — Riverside, California, United States
• Novartis Investigative Site — Rolling Hills Estates, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — San Jose, California, United States
• Novartis Investigative Site — Stockton, California, United States
• Novartis Investigative Site — Colorado Springs, Colorado, United States
• Novartis Investigative Site — Denver, Colorado, United States
• Novartis Investigative Site — Denver, Colorado, United States
• Novartis Investigative Site — Sarasota, Florida, United States
• Novartis Investigative Site — Owensboro, Kentucky, United States
• Novartis Investigative Site — North Dartmouth, Massachusetts, United States
• Novartis Investigative Site — Minneapolis, Minnesota, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Papillion, Nebraska, United States
• Novartis Investigative Site — Skillman, New Jersey, United States
• Novartis Investigative Site — Charlotte, North Carolina, United States
• Novartis Investigative Site — Cincinnati, Ohio, United States
• Novartis Investigative Site — Encinitas, California, United States

Full record on ClinicalTrials.gov

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