Status:
COMPLETED
A Study of JNJ-38518168 in Symptomatic Adult Participants With Uncontrolled, Persistent Asthma
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of JNJ-38518168 compared with placebo in participants with persistent asth...
Detailed Description
This study will be randomized (treatment group assigned by chance, like flipping a coin), double-blind (study investigators and participants will not know what treatment is being administered), and pl...
Eligibility Criteria
Inclusion
- 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 β2-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
Exclusion
- 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 Screening 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) greater than or equal to 40 kg/m2
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT01823016
Start Date
September 1 2013
End Date
July 1 2015
Last Update
April 29 2025
Active Locations (54)
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1
Scottsdale, Arizona, United States
2
Los Angeles, California, United States
3
Mission Viejo, California, United States
4
San Diego, California, United States