CTRI/2010/091/001010招募中2 期
A Double-Blind, Randomized, Placebo-Controlled, Parallel Group Exploratory Study of the Safety and Efficacy of JNJ-39758979 in the Treatment of Adults with Persistent Asthma
Johnson & Johnson Pharmaceutical Research and Development0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
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.Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- •2.To participate in the optional pharmacogenomic component of this study, subjects (or their legally acceptable representative) must have signed the informed consent form for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study (where local regulations permit). Refusal to consent for this component does not exclude a subject from participation in the clinical study.
- •3.Man or woman between 18 and 65 years of age, inclusive
- •4.Healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening.
- •5.Chest x-ray performed within the past 6 months without clinically significant abnormalities.
- •6.Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, coagulation tests, or urinalysis are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities or deviations from normal as not clinically significant or as appropriate and reasonable for the population under study. This determination must be recorded in the subject's source documents and initialed by the investigator.
- •7.Medically confirmed diagnosis of persistent asthma according to EPR-3 and GINA guidelines for at least six months.
- •8.FEV1 of 55-85% predicted measured >6 hours after the most recent use of a bronchodilator at screening and randomization. At screening only, a repeat assessment can be performed within 7 days of the initial assessment if a subject does not meet this criterion.
- •9.Evidence of FEV1 reversibility at screening as demonstrated by an increase in FEV1 of at least 12% and 200 ml 15 to 30 minutes after administration of 4 puffs (360 mcg) of albuterol/salbutamol via a metered-dose inhaler (MDI) or 2.5 mg albuterol/salbutamol nebulized solution. Subjects suspected of being reversible but not meeting this criterion at Screening may have one repeat reversibility assessment within 7 days of the initial assessment. If a subject does not meet this reversibility criterion either at screening or at repeat assessment but has FEV1 reversibility documented within 12 months of screening, they may be included following discussion with the sponsor.
- •10.Score of 1.5 or greater on the Asthma Control Questionnaire (ACQ) at screening.
- •11.Short-acting beta-agonist (SABA) use ≥5 times in the 2 weeks prior to screening.
- •12.Based on investigator's assessment, an adequate supply of albuterol/salbutamol in a MDI for use as a quick-relief medication as needed throughout the Run-in and Treatment Periods (other SABAs are not permitted).
- •13.Women must be one of the following:
- •a.postmenopausal (not experiencing a menstrual period for a minimum of two years),
- •b.surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
- •c.abstinent (at the discretion of the investigator/per local regulations),
- •d.or if sexually active, be practicing an effective method of birth control which must be used consistently for 3 months prior to run-in (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method [e.g., condoms, diaphragm, or c
排除标准
- •1.History of life-threatening asthma attack requiring intubation or ICU admission, hospitalization for asthma within 5 years of screening, or emergency department (ED) treatment of asthma within one (1) month of screening.
- •2.Have current signs or symptoms of liver insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive or uncontrolled in the investigator?s discretion, or have any known malignancy or a history of malignancy within the previous 5 years (with the exception of nonmelanoma skin cancer that has been treated with no evidence of recurrence).
- •3.History of drug/alcohol abuse within 5 years
- •4.Moderate or severe renal insufficiency as measured by creatinine clearance less than 50 mL/min as calculated by Cockcroft-Gault formula
- •5.Positive anti-HCV, anti-HIV test, or evidence of HBV infection (positive HBsAg and/or HBcAb test) at screening.
- •6.Cigarette smoking within 12 months prior to Screening or a greater than 10 pack year smoking history, as determined by medical history or subject?s verbal report.
- •7.Known allergies, hypersensitivity, or intolerance to JNJ-39758979 or its excipients (refer to Section 15.1 Physical Description of Study Drug(s))
- •8.Have received, or are expected to receive, any live virus, including FluMist®, or bacterial vaccination within 1 month prior to the first administration of study agent, during the trial, or within 3 months after the last dose of study drug.
- •9.Use of disallowed therapies:
- •a.Systemic corticosteroids within 4 weeks of Week ?2 (start of run-in period)
- •b.Inhaled corticosteroids (ICS) within 2 weeks of Week -2
- •c.Long-acting beta agonists (LABA) within 1 week of Week ?2
- •d.Oral beta agonists within 1 week of Week ?2
- •e.Cromolyns, leukotriene inhibitors (zileuton, zafirlukast, montelukast), theophylline or inhaled anti-cholinergic agents within 1 week of Week -2
- •f.Omalizumab within 130 days (5 half-lives) of Week ?2
- •10.Initiation or discontinuation of allergen immunotherapy within 3 months of Randomization (Stable doses of allergen immunotherapy are allowed).
- •11.History of upper respiratory infection (URI) [rhinitis or sinusitis] within 2 weeks of Week ?2 (Start of Run-in Period). Subjects developing a URI between Week -2 and Randomization may repeat the Run-in Period after discussion with the medical monitor.
- •12.Screening or baseline (randomization) QTc (Fridericia) interval >450 msec (men) or >470 msec (women), or a history of additional risk factors for torsades de pointe (eg, heart failure, hypokalemia, family history of Long QT Syndrome)
- •13.Received an investigational drug or used an investigational medical device within 30 days before the planned start of treatment or are currently enrolled in an investigational study.
- •14.Pregnant or breast-feeding
- •15.Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
- •16.Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
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