Status:
COMPLETED
A Study to Assess the Effect of QAW039 in Non-atopic Asthmatic Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
This was a multi-centre, randomised, placebo-controlled, double blind, 3-arm study designed to compare the efficacy and safety of a once daily dose of QAW039 with placebo in non-atopic and atopic asth...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
345 Patients enrolled
Trial Details
Trial ID
NCT01836471
Start Date
May 1 2013
End Date
February 1 2016
Last Update
March 20 2017
Active Locations (76)
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1
Novartis Investigative Site
Encinitas, California, United States, 92024
2
Novartis Investigative Site
Huntington Beach, California, United States, 92647
3
Novartis Investigative Site
Los Angeles, California, United States, 90025
4
Novartis Investigative Site
Los Angeles, California, United States, 90048