CTRI/2018/01/011183进行中（未招募）3 期
A 2-treatment period, randomized, placebo-controlled,multicenter parallel-group study to assess the safety ofQAW039 when added to existing asthma therapy in GINAsteps 3, 4 and 5 patients with uncontrolled asthma
ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients completing A PRIOR PHASE 3 STUDY OF QAW039:
- •1a. Informed consent and assent (if applicable) may be obtained at Visit 1 or within 14 days
- •of Visit 1. Informed consent and assent (if applicable) must be obtained before any study
- •assessment is performed.
- •2a. Completion of the treatment period (on blinded study drug) of a prior Phase 3 study of
- •QAW039 (i.e., did not discontinue blinded study treatment prematurely).
- •3a. 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:
- •1a. Informed consent and assent (if applicable) may be obtained at Visit 1 or within 14 days
- •of Visit 1. Informed consent and assent (if applicable) must be obtained before any study
- •assessment is performed.
- •2b. Male and female patients at a minimum age of 12 years (or higher minimum age limit as
- •allowed by health authority and/or ethics committee/institutional review board (IRB)
- •approvals).
- •3b. Patients must have a diagnosis of asthma (according to GINA 2016) for a period of at least
- •24 months prior to screening visit (Visit 1).
- •4b. Patients have been treated with GINA steps 4 or 5 standard-of-care (SoC) asthma therapy
- •for at least 3 months prior to Visit 1. The doses must have been stable for at least 4 weeks
- •prior to Visit 1.
- •5b. Demonstration of inadequate control of asthma based on an ACQ score greater than or equal to 1.5 at Visit 1.
- •6b. For patients aged greater than or equal to 18 years, FEV1 of greater than or equal to 40% and less than or equal to 85% of the predicted normal value for the patient, after withholding bronchodilators at Visit 1. For patients aged 12 to less than 18 years, FEV1 of greater than or equal to 40% and less than or equal to 90% of the predicted normal value for the patient, after withholding bronchodilators at Visit 1.
- •7b. An increase of greater than or equal to 12% and greater than or equal to 200 ml in FEV1 approximately 10 to 15 minutes after
- •administration of 400 mcg of salbutamol/albuterol (or equivalent dose) prior to randomization. Spacer devices are not permitted during reversibility testing. All patients must perform a reversibility test at the Visit 1.
排除标准
- •Patients completing a prior phase 3 study of QAW039:
- •1. Pregnant or nursing (lactating) women.
- •2. Women of child-bearing potential unless they are using basic methods of contraception during dosing of study drug
- •3. Patients who did not complete the Treatment Period on blinded study drug of the prior QAW039 study they participated in.
- •4. Inability to comply with all study requirements.
- •5. Patient who experienced a serious and drug-related AE in the prior QAW039 study they participated in.
- •Patients who have not previously participated in a study of QAW039:
- •6. Use of other investigational drugs within 5 half-lives of study entry, or within 30 days, whichever is longer.
- •7. Subjects who have participated in another trial of QAW039 (i.e. the patient was randomized in another study).
- •8. A QTcF (Fridericia) greater than or equal to 450 msec (male) or greater than or equal to 460 msec (female).
- •9. History of malignancy with the exception of local basal cell carcinoma of the skin
- •10. Pregnant or nursing (lactating) women.
- •11. Serious co-morbidities
- •12. Patients on greater than 20 mg of simvastatin, greater than 40 mg of atorvastatin, greater than 40 mg of pravastatin, or greater than 2 mg of pitavastatin. Statin doses less than or equal to these doses as well as other statins will be permitted during the study.
研究者
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