Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma
Status: | Recruiting |
---|---|
Conditions: | Asthma |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 12 - Any |
Updated: | 12/15/2018 |
Start Date: | October 31, 2017 |
End Date: | November 20, 2019 |
Contact: | Novartis Pharmaceuticals |
Email: | novartis.email@novartis.com |
Phone: | 1-888-669-6682 |
A 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma
A randomized, multicenter, double-blind, placebo- controlled parallel-group study to
determine the efficacy and safety of QAW039, compared with placebo, when added to
standard-of-care (SoC) asthma therapy in adult and adolescent (≥ 12 years) patients with
uncontrolled asthma with respect to change from baseline in forced expiratory volume in 1
second (FEV1) at the end of 12 weeks of treatment.
determine the efficacy and safety of QAW039, compared with placebo, when added to
standard-of-care (SoC) asthma therapy in adult and adolescent (≥ 12 years) patients with
uncontrolled asthma with respect to change from baseline in forced expiratory volume in 1
second (FEV1) at the end of 12 weeks of treatment.
Inclusion Criteria:
- A diagnosis of asthma (according to GINA 2016) for a period of at least 6 months.
- Treated with medium dose inhaled corticosteroid (ICS), or high dose ICS, or low dose
ICS plus long- acting beta agonist (LABA), or low dose ICS plus leukotriene receptor
antagonist (LTRA), or medium dose ICS plus LABA for at least 3 months prior to Visit 1
and the doses have been stable for at least 4 weeks prior to Visit 1.
- FEV1 of ≤85% for patients aged ≥18 years. FEV1 of ≤90% for patients aged 12 to <18
years.
- Daytime asthma symptom score (0 to 6 scale) of ≥1 per day during 4 of the last 7 days
of the placebo run- in period.
- Total daily SABA use ≥1 puff per day during 4 of the last 7 days of the placebo run-in
period.
- Demonstrated reversible airway obstruction.
- Asthma control questionnaire (ACQ) score ≥ 1.5.
Exclusion Criteria:
- Use of other investigational drugs within 5 half-lives of enrollment, or within 30
days, whichever is longer.
- A resting QTcF (Fridericia) ≥450 msec (male) or
≥460 msec (female).
- Pregnant or nursing (lactating) women.
- Serious co-morbidities.
- Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or
>2 mg of pitavastatin.
Other protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
42
sites
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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