A Study of JNJ-38518168 in Symptomatic Adult Participants with Uncontrolled, Persistent Asthma
- Conditions
- Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]MedDRA version: 14.1 Level: LLT Classification code 10068462 Term: Eosinophilic asthma System Organ Class: 100000004855Asthma
- Registration Number
- EUCTR2012-004920-39-GB
- Lead Sponsor
- Janssen-Cilag International N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 165
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Baseline to Week 16;<br> Primary end point(s): Change from baseline in prebronchodilator forced expiratory<br> volume in 1 second (preBD FEV1)<br> ;Main Objective: The primary objective is to assess the efficacy (as measured by the change from baseline in prebronchodilator percent-predicted forced expiratory volume in 1 second [FEV1]) of JNJ-38518168 compared with placebo in subjects with eosinophilic persistent asthma that is inadequately controlled despite current treatment.;Secondary Objective: The secondary objectives are to assess the safety, efficacy (as measured by improvement in asthma control), tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of JNJ-38518168 compared with placebo in subjects with eosinophilic persistent asthma that is inadequately controlled despite current treatment.
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Baseline to Week 16;<br> Secondary end point(s): 1. Change from baseline in Asthma Control Questionnaire (ACQ)<br> 2. Change from baseline in postbronchodilator forced expiratory volume in 1 second (postBD FEV1)<br> 3. Change from baseline in weekly average of daytime asthma diary<br> symptom scores<br> 4. Change from baseline in weekly average of nighttime asthma diary symptom scores<br> 5. Change from baseline in weekly average of number of puffs in a day that rescue medication is used<br>