A Study of JNJ-38518168 in Symptomatic Adult Participants With Uncontrolled, Persistent Asthma
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|ClinicalTrials.gov Identifier: NCT01823016|
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : June 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Placebo Drug: JNJ-38518168||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||166 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study of JNJ-38518168 in Symptomatic Adult Subjects With Uncontrolled, Persistent Asthma|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
|Placebo Comparator: Placebo||
Placebo tablet, taken once daily
JNJ-38518168, 30 mg tablet, taken once daily
- Change from baseline in prebronchodilator forced expiratory volume in 1 second (preBD FEV1) [ Time Frame: Baseline to Week 16 ]Expressed as percent of predicted value.
- Change from baseline in Asthma Control Questionnaire (ACQ) [ Time Frame: Baseline to Week 16 ]ACQ evaluates clinical impairment that participants with asthma may experience. Items are scored on a 7-point scale (0 = good control, 6 = poor control). Higher mean scores reflect poorer control.
- Change from baseline in postbronchodilator forced expiratory volume in 1 second (postBD FEV1) [ Time Frame: Baseline to Week 16 ]Expressed as percent of predicted value.
- Change from baseline in weekly average of daytime asthma diary symptom scores [ Time Frame: Baseline to Week 16 ]Asthma diaries include questions about the frequency/severity of symptoms and impact on activities. Higher scores indicate more asthma symptoms.
- Change from baseline in weekly average of nighttime asthma diary symptom scores [ Time Frame: Baseline to Week 16 ]Asthma diaries include questions about number of nocturnal awakenings.
- Change from baseline in weekly average of number of puffs in a day that rescue medication is used [ Time Frame: Baseline to Week 16 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01823016
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|