A 12-WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF QAW039 WHEN ADDED TO STANDARD-OF-CARE ASTHMA THERAPY IN PATIENTS WITH UNCONTROLLED ASTHMA

OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 91 人开始时间: 2018年6月14日最近更新: 2023年9月4日

适应症

试验速览

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•1. Written informed consent and assent (if applicable) must be obtained within 14 days prior to or at Visit 1 before any assessment is performed including any adjustment to asthma medication.2. Male and female patients at a minimum age of 12 years (or higher minimum age limit as allowed by health authority and/or independent ethics committee/institutional review board (IEC/IRB) approvals).3. Patients must have a diagnosis of asthma (according to GINA 2016) for a period of at least 6 months prior to Visit 1.4. Patients who have been treated with: Medium dose 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 1.5. For patients aged ≥18 years, FEV1 of ≤85% of the predicted normal value for the patient, after withholding bronchodilators at Visit 1 and Visit 101. For patients aged 12 to <18 years, FEV1 of ≤90% of the predicted normal value for the patient, after withholding bronchodilators at Visit 1 and Visit 101.

•1. Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.
•2. History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes to QAW039.
•3. History of lactose or milk sensitivity.
•4. Patients with a history or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study such as:
•- Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second or third degree atrioventricular (AV) block without a pacemaker.
•- History of familial long QT syndrome or known family history of Torsades de Pointes.
•5. Patients with a resting QTcF (Fridericia) ≥450 msec (male) or ≥460 msec (female) at Visit 1.
•6. Use of agents known to prolong the QT interval unless it can be permanently discontinued for the duration of the study.
•7. Patients with a history of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.

发起方

OVARTIS BIOSCIENSES PERU S.A.,