To assess the clinical effect of QAW039 in non-atopic asthmatics taking low dose of inhaled corticosteroids (ICS) as background therapy.
- Conditions
- Asthma
- Registration Number
- CTRI/2014/07/004743
- Lead Sponsor
- Novartis Healthcare Private Limited
- Brief Summary
This is a randomized, double-blind, placebo-controlled study
to determine whether, in patients with persistent, moderate-to-severe, non-atopic (skin prick test- and specific IgE-negative) asthma inadequately controlled by inhaled corticosteroid (ICS) therapy (100 μg fluticasone BID), 12-weeks treatment with QAW039 at a dose of 450 mg QD (compared to placebo) improves FEV1 and symptom control as measured by the ACQ.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 336
•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.
•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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in trough FEV1 from baseline to 12 weeks of post-baseline treatment in non-atopic asthmatic patients. Baseline and Week 12 To assess the efficacy of QAW039 by Lung Function Assessed by trough Forced Expiratory Volume for 1 Second (FEV1) in non-atopic asthmatics Baseline and Week 12
- Secondary Outcome Measures
Name Time Method To assess the change in asthma control as measured by the asthma control questionnaire (ACQ) from baseline to week 12. Baseline to Week 12
Trial Locations
- Locations (9)
Getwell Hospital and Research Institute
🇮🇳Nagpur, MAHARASHTRA, India
J.S.S.Medical College
🇮🇳Mysore, KARNATAKA, India
Kamineni Hospital Pvt Limited
🇮🇳Hyderabad, ANDHRA PRADESH, India
KRIMS hospital
🇮🇳Nagpur, MAHARASHTRA, India
M S Ramaiah Medical College and Hospital
🇮🇳Bangalore, KARNATAKA, India
Metro Multi Speciality Hospital
🇮🇳Nagar, UTTAR PRADESH, India
Sri Bala Medical Centre & Hospital
🇮🇳Coimbatore, TAMIL NADU, India
TB & Chest Hospital
🇮🇳Goa, GOA, India
Victoria Hospital
🇮🇳Bangalore, KARNATAKA, India
Getwell Hospital and Research Institute🇮🇳Nagpur, MAHARASHTRA, IndiaDr Rajesh SwarnakarPrincipal investigator91-9822225130rajeshswarnakar@yahoo.co.in