CTRI/2018/06/014543进行中（未招募）3 期
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 - ZEA
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
- •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
- •3Patients 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:
- •ï?· Medium dose ICS, or
- •ï?· High dose ICS, or
- •ï?· Low dose ICS plus long-acting beta agonist (LABA), or
- •ï?· Low dose ICS plus leukotriene receptor antagonist (LTRA), or
- •ï?· 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 at least 3 months prior to Visit 1 and the doses have been stable for at least 4 weeks
- •prior to Visit 1
- •6 Patients must have a 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
- •7 Patients must have a total daily SABA use >=1 puff per day during 4 of the last 7 days of
- •the placebo run-in period
- •8 Demonstrated reversible airway obstruction as determined by the central reader from the
- •spirometry vendor at Visit 1 or Visit 101. Reversibility is defined as an increase of >=12%
- •and >=200 ml in FEV1 approximately 10 to 15 minutes after administration of 400 mcg of
- •salbutamol/albuterol (or equivalent). Spacer devices are permitted for administration of
- •salbutamol/albuterol (or equivalent) during reversibility testing only. The Investigator or
- •delegate may decide whether or not to use a spacer for the reversibility testing
- •If reversibility is not demonstrated at Visit 1, reversibility will be attempted at Visit
- •101. If not achieved at Visit 101, then one additional attempt to demonstrate
- •reversibility is permitted within 4 days following Visit 101 in an ad -hoc visit to meet
- •this eligibility criterion
- •If reversibility is not demonstrated at Visit 1, reversibility will be attempted at Visit
- •101. If not achieved at Visit 101, then one additional attempt to demonstrate
- •reversibility is permitted within 4 days following Visit 101 in an ad -hoc visit to meet
- •this eligibility criterion
- •9 An ACQ score >= 1.5 at Visit 199
排除标准
- •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
- •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:
- •ï?· Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular
- •tachycardia, and clinically significant second or third degree atrioventricular (AV)
- •block without a pacemaker.
- •ï?· 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
- •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.
- •8. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female
- •after conception and until the termination of gestation, confirmed by a positive human
- •chorionic gonadotropin (hCG) laboratory test.
- •9. Women of child-bearing potential, defined as all women physiologically capable of
- •becoming pregnant, unless they are using basic methods of contraception during dosing of
- •study drug. Basic contraception methods include:
- •ï?· Total abstinence (when this is in line with the preferred and usual lifestyle of the
- •subject) if allowed as an effective method of contraception by local regulations.
- •Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods)
- •and withdrawal are not acceptable methods of contraception
- •ï?· Female sterilization (have had surgical bilateral oophorectomy with or without
- •hysterectomy) or tubal ligation at least six weeks before taking study treatment. In
- •case of oophorectomy alone, only when the reproductive status of the woman has
- •been confirmed by follow up hormone level assessment
- •ï?· Male sterilization (at least 6 months prior to screening). For female patients on the
- •study, the vasectomized male partner must be the sole partner for that subject
- •chemical classes to QAW039.
研究者
相似试验
招募中
不适用
A 12-week, Multicenter, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of KBL982 on Improving Alcoholic Liver DysfunctioKCT0006987Kobiolabs105
已完成
2 期
A 12-week, Multicenter, Randomized, Double-blind, Parallel-arm, Placebo-controlled Study to Assess the Efficacy and Safety of CSJ117, When Added to Existing Asthma Therapy in Patients => 18 Years of Age With Severe Uncontrolled Asthma.AsthmaJPRN-jRCT2080225330ovartis Pharma. K.K.625
已完成
2 期
Efficacy and Safety of BGG492 as Adjunctive Treatment in Patients With Partial Onset SeizuresCTRI/2010/091/001213ovartis Health care Private Limited126
进行中（未招募）
不适用
A 12-week, Multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of MPCO on Mild Cognitive ImpairmentKCT0008219INE B150
招募中
不适用
A 12-week, Multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of DKB-140 on Gingival HealthKCT0009501Dong Kook Pharm120