EUCTR2016-001560-11-FRActive, not recruitingPhase 1
A 2-treatment period, randomized, placebo-controlled, multicenter parallel-group study to assess the safety of QAW039 when added to existing asthma therapy in GINA steps 3, 4 and 5 patients with uncontrolled asthma. - SPIRIT
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ovartis Pharma AG
- Enrollment
- 2,344
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •Patients completing a prior Phase 3 study of QAW039:
- •- Informed consent and assent (if applicable).
- •-Completion of the Treatment Period (on blinded study drug) of a prior Phase 3 study of QAW039.
- •-Patient is able to safely continue into the study as judged by the investigator.
- •Patients who have not previously participated in a study of QAW039:
- •-Written informed consent.
- •-Male and female patients aged =12 years.
- •-A diagnosis of asthma, uncontrolled on GINA 3/4/5 asthma medication. -Evidence of airway reversibility or airway hyper- reactivity.
- •-FEV1 of =40% and =85% of the predicted normal value.
- •-An ACQ score =1.5 prior to entering the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 80
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2031
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 233
Exclusion Criteria
- •Patients completing a prior phase 3 study of QAW039:
- •- Pregnant or nursing (lactating) women.
- •- Women of child-bearing potential unless they are using basic methods of contraception during dosing of study drug
- •- Patients who did not complete the Treatment Period on blinded study drug of the prior QAW039 study they participated in.
- •- Inability to comply with all study requirements.
- •- Patient who experienced a serious and drug-related AE in the prior QAW039 study they participated in.
- •- Patient who developed a condition during the prior study that would have excluded them from participation in that study.
- •Patients who have not previously participated in a study of QAW039:
- •-Use of other investigational drugs within 5 half-lives of study entry, or within 30
- •days, whichever is longer.
- •-Subjects who have participated in another trial of QAW039.
- •-A QTcF (Fridericia) =450 msec (male) or =460 msec (female).
- •-History of malignancy with the exception of local basal cell carcinoma of the skin.
- •-Pregnant or nursing (lactating) women.
- •-Serious co-morbidities.
- •-Patients on greater than 20 mg of simvastatin
Investigators
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