A Study to Assess the Effect of QAW039 in Non-atopic Asthmatic Patients
Status: | Completed |
---|---|
Conditions: | Asthma |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | May 2013 |
End Date: | February 2016 |
A Double-blind, Placebo-controlled, Study Examining the Effect of Orally Administered QAW039 (450 mg QD) on FEV1 and ACQ in Non-atopic, Asthmatic Patients With a Baseline, Pre-bronchodilator FEV1 of 40-80% Predicted, Inadequately Controlled With Low Dose ICS Therapy
The purpose of the study is to assess the clinical effect of QAW039 in non-atopic asthmatics
taking low dose Inhaled Corticosteroid (ICS) as background therapy.
taking low dose Inhaled Corticosteroid (ICS) as background therapy.
This is 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 asthmatics both inadequately controlled despite receiving a low dose ICS
background therapy, over a 12 week treatment period. Efficacy and safety of a once daily
dose of QAW039 is also compared with an increased dose of ICS in atopic asthmatics taking
low dose ICS as background therapy.
to compare the efficacy and safety of a once daily dose of QAW039 with placebo in non-atopic
and atopic asthmatics both inadequately controlled despite receiving a low dose ICS
background therapy, over a 12 week treatment period. Efficacy and safety of a once daily
dose of QAW039 is also compared with an increased dose of ICS in atopic asthmatics taking
low dose ICS as background therapy.
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
We found this trial at
31
sites
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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