A Study of JNJ-38518168 in Symptomatic Adult Participants With Uncontrolled, Persistent Asthma (NCT01823016) | Clinical Trial Compass
CompletedPhase 2
A Study of JNJ-38518168 in Symptomatic Adult Participants With Uncontrolled, Persistent Asthma
United States166 participantsStarted 2013-09
Plain-language 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 asthma that is inadequately controlled despite current treatment.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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…
What they're measuring
1
Change from baseline in prebronchodilator forced expiratory volume in 1 second (preBD FEV1)