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

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Fluticasone; Indoleacetic Acids; Xhance

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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