A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study of JNJ-38518168 in Symptomatic Adult Subjects with Uncontrolled, Persistent Asthma - Not Applicable

Janssen-Cilag International N.V.0 个研究点目标入组 160 人开始时间: 2013年4月3日最近更新: 2016年8月8日

适应症

试验速览

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•Principal Inclusion Criteria in Lay Language (for a complete list of
•inclusion criteria refer to the protocol):
•Have a diagnosis of asthma for at least 26 weeks, confirmed by the investigator at Screening Visit 1 -Have been receiving inhaled corticosteroid (ICS) (=1000 µg/day fluticasone or its equivalent) for at least 12 weeks prior to Screening Visit 1 -At Screening Visit 1, be receiving the same dose of ICS =1000 µg/day fluticasone (or equivalent) alone or in conjunction with long-acting ß2-agonist
•(LABA) and/or montelukast for at least 4 weeks prior to screening with no changes in dose or dosing regimen of any of these therapies during that 4 week period prior to screening -Have an Asthma Control Questionnaire (ACQ) score =1.5 at Screening Visit 1 -Have a prebronchodilator forced expiratory volume in
•1 second (FEV1) equal to 40% to 80%, inclusive, of predicted value at Screening Visit 1 -Have a =12% relative change and =200 mL change in FEV1 postbronchodilator at either Screening Visit 1 or 2
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 128
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 32

•Principal Exclusion Criteria in Lay Language (for a complete list of
•exclusion criteria refer to the protocol):
•Has ever had a life-threatening asthma attack including respiratory arrest, intubation, or intensive care unit (ICU) admission due to asthma -Has a history of any other chronic respiratory condition including, but not limited to, chronic obstructive pulmonary disease (COPD), bronchiolitis, bronchiectasis, allergic
•bronchopulmonary aspergillosis (mycosis), occupational asthma, sleep apnea, pulmonary hypertension, or any other obstructive pulmonary disease -Has any use of the following asthma therapies: systemic corticosteroids within 6 weeks of Screening Visit 1; oral beta-agonists within 4 weeks of Screening Visit 1;
•cromolyns within 4 weeks of Screening Visit 1; leukotriene inhibitors other than montelukast within 4 weeks
•of Screening Visit 1; theophylline within 4 weeks of S reening Visit 1; inhaled anti-cholinergic agents within 4 weeks of Screening Visit 1; or omalizumab within 130 days of Screening Visit 1 -Has initiated or discontinued allergen immunotherapy within 12 weeks of Screening Visit 1 -Has smoked within 3 years of Screening Visit 1 or has a history of smoking = 10 pack years -Body-Mass Index (BMI) >32 kg/m2

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