PER-106-11未知未知
A RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING, MULTI-CENTRE TRIAL OF QAW039 (1-450 mg p.o) TO INVESTIGATE THE EFFECT ON FEV1 AND ACQ IN PATIENTS WITH MODERATE-TO-SEVERE, PERSISTENT, ALLERGIC ASTHMA, INADEQUATELY CONTROLLED WITH ICS THERAPY
OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 53 人开始时间: 2012年1月24日最近更新:
试验速览
- 阶段
- 未知
- 发起方
- 入组人数
- 53
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
- 年龄范围
- 18 至 100（—）
- 性别
- All
入选标准
- •1. MALES AND FEMALES OF ANY RACE WHO ARE BETWEEN 18 AND 65 YEARS OLD AT THE TIME INFORMED CONSENT IS PROVIDED.
- •2. PHYSICIAN DIAGNOSIS OF ASTHMA, AS PER [GINA] GUIDELINES, AND CURRENTLY PRESCRIBED ICS THERAPY.
- •3. PATIENTS WITH A PRE-BRONCHODILATOR FEV₁ VALUE OF 40% TO 80% OF INDIVIDUAL PREDICTED VALUE AT SCREENING AND AT RANDOMIZATION, AND THE VALUE AT THE RANDOMIZATION SHOULD BE WITHIN 15% OF THE SCREENING FEV₁.
- •4. PATIENTS SHOULD BE ALLERGIC OR ATOPIC, AS DIAGNOSED HISTORICALLY OR PRIOR TO ENTRY INTO THE STUDY.
- •5. PATIENTS WHO ARE DEMONSTRATE TO HAVE REVERSIBLE AIRWAY OBSTRUCTION OR AIRWAYS HYPER-REACTIVITY OR HAVE SHOWN EITHER OF SUCH RESPONSES IN PREVIOUS TEST(S) WITHIN THE LAST 5 YEARS.
排除标准
- •1. USE OF OTHER INVESTIGATIONAL DRUGS AT THE TIME OF ENROLLMENT, OR WITHIN 30 DAYS OR 5 HALF-LIVES OF ENROLLMENT, WHICHEVER IS LONGER.
- •2. HISTORY OF HYPERSENSITIVITY TO ANY OF THE STUDY DRUGS OR TO DRUGS OF SIMILAR CHEMICAL CLASSES (CRTh2 ANTAGONISTS).
- •3. HISTORY OF LONG QT SYNDROME OR WHOSE QTc INTERVAL (FRIDERICIA´S) IS PROLONGED > 450 MSEC FOR MALES AND FEMALES AT SCREENING AS ASSESSED BY CENTRAL ECG INTERPRETATION.
- •4. HISTORY MALIGNANCY OF ANY ORGAN SYSTEM (OTHER THAN LOCALIZED BASAL CELL CARCINOMA OF THE SKIN), TREATED OR UNTREATED, WITHIN THE PAST 5 YEARS, REGARDLESS OF WHETHER THERE IS EVIDENCE OF LOCAL RECURRENCE OR METASTASES.
- •5. PREGNANT OR NURSING (LACTATING) WOMEN, WHERE PREGNANCY IS DEFINED AS THE STATE OF A FEMALE AFTER CONCEPTION AND NTIL THE TERMINATION OF GESTATION, CONFIRMED BY A POSITIVE hCG LABORATORY TEST (> 5 mIU/mL).
- •6. WOMEN OF CHILD-BEARING POTENTIAL, DEFINED AS ALL WOMEN PHYSIOLOGICALLY CAPABLE OF BECOMING PREGNANT, MUST USE EFECTIVE CONTRACEPTION DURING THE STUDY AND FOR 5 DAYS (5 HALF-LIVES) AFTER TREATMENT.
研究者
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