Clinical trial NCT00946569: A Study of the Safety and Effectiveness of JNJ-39758979 in the Treatment of Adults With Persistent Asthma
Official title: A Double-Blind, Randomized, Placebo-Controlled, Parallel Group Exploratory Study of the Safety and Efficacy of JNJ-39758979 in the Treatment of Adults With Persistent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
Persistent asthma
Adults with persistent asthma
Chronic asthma
JNJ-39758979
Placebo
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2009-07-27
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of once daily oral administration of JNJ-39758979 in the treatment of adults (18 to 65 years of age) with persistent asthma.

Detailed description: This is a multicenter, double-blind (neither physician nor participants knows the treatment that the participant receives), randomized (study medication is assigned by chance), placebo-controlled (an inactive substance is compared with a medication to test whether the medication has a real effect in a clinical study), parallel group (each group of participants will be treated at the same time), exploratory study (JNJ-39758979 is introduced in participants with asthma for the first time). This study consists of 4 phases: screening phase (4 weeks prior to the start of the run-in period), placebo run-in phase (2 weeks prior to the start of treatment phase), double-blind treatment phase (12 weeks), and posttreatment phase (5 weeks). Approximately 100 participants will be randomly allocated to 1 of 2 treatment groups: Treatment A (participants will receive JNJ-39758979 once daily) and treatment B (participants will receive placebo once daily). Safety will be evaluated by assessment of adverse events, clinical laboratory tests, vital signs, physical examination, and 12-lead electrocardiogram. Total study duration for each participant will be approximately 23 weeks.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of asthma for at least 6 months
* Short-acting beta-agonist use greater than or equal to 5 times in the 2 weeks prior to screening
* Healthy on the basis of physical examination, medical history, vital signs, and 12 lead ECG performed at screening
* Having adequate laboratory values
* No history of/active or latent tuberculosis
* Agree to use protocol defined contraceptive methods

Exclusion Criteria:

* History of life-threatening asthma attack requiring hospitalization for asthma within 5 years of screening, or emergency department treatment of asthma within the last month
* Moderate or severe renal insufficiency
* Cigarette smoking within the last year - Viral or bacterial vaccination within the last month (eg, FluMist)
* Human Immunodeficiency Virus (HIV) or Hepatitis B or C positive

Primary outcomes:
measure: Percent change from baseline to Week 12 in pre-bronchodilator percent predicted Forced Expiratory Volume in 1 second (FEV1) value
timeFrame: Baseline (Week 0) and Week 12
Secondary outcomes:
measure: Percent change from baseline in pre-bronchodilator percent predicted Forced Expiratory Volume in 1 second (FEV1) value
timeFrame: Week 1, Week 2, Week 4, and Week 8
measure: Percent change from baseline in post-bronchodilator percent predicted Forced Expiratory Volume in 1 second (FEV1) value
timeFrame: Week 4 and Week 12
measure: Percent change from baseline in pre-bronchodilator percent predicted Forced Vital Capacity (FVC) value
timeFrame: Week 1, Week 2, Week 4, Week 8, and Week 12
measure: Percent change from baseline in post-bronchodilator percent predicted Forced Vital Capacity (FVC) value
timeFrame: Week 4 and Week 12
measure: Percent change from baseline in pre-bronchodilator percent predicted Forced Expiratory Flow (FEF) 25-75 value
timeFrame: Week 1, Week 2, week 4, Week 8, and Week 12
measure: Percent change from baseline in post-bronchodilator percent predicted Forced Expiratory Flow (FEF) 25-75 value
timeFrame: Week 4 and week 12
measure: Percent change from baseline in pre-bronchodilator percent predicted Forced Expiratory Volume in 1 second/Forced Vital Capacity (FEV1/FVC) value
timeFrame: Week 1, Week 2, Week 4, Week 8, and Week 12
measure: Percent change from baseline in post-bronchodilator percent predicted Forced Expiratory Volume in 1 second/Forced Vital Capacity (FEV1/FVC) value
timeFrame: Week 4 and Week 12
measure: Change from baseline to Week 12 in Asthma Daily Diary (ADD) data
timeFrame: Week 12
measure: Number of participants with worsening of asthma
timeFrame: From baseline (Week 0) to Week 12
measure: Time to worsening of asthma
timeFrame: From baseline (Week 0) to Week 12
measure: Plasma concentrations of JNJ-39758979
timeFrame: Baseline (Week 0), Week 1, Week 2, Week 4, and Week 12
measure: Serum concentrations of JNJ-39758979
timeFrame: Baseline (Week 0), Week 1, Week 2, Week 4, and Week 12
measure: Number of participants with adverse events
timeFrame: From screening (Week -6) to Week 17
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Cypress
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Normal
country: United States
state: Illinois
city: North Dartmouth
country: United States
state: Massachusetts
city: Papillion
country: United States
state: Nebraska
city: Cincinnati
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Medford
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Dallas
country: United States
state: Texas
city: Waco
country: United States
state: Texas
city: Madison
country: United States
state: Wisconsin
city: Kelowna
country: Canada
state: British Columbia
city: Niagara Falls
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Quebec
country: Canada
city: Chennai
country: India
city: Mumbai
country: India
city: Mysore
country: India
city: Pune
country: India
city: Bucuresti
country: Romania
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Kollmeier AP, Greenspan A, Xu XL, Silkoff PE, Barnathan ES, Loza MJ, Jiang J, Zhou B, Chen B, Thurmond RL. Phase 2a, randomized, double-blind, placebo-controlled, multicentre, parallel-group study of an H4 R-antagonist (JNJ-39758979) in adults with uncontrolled asthma. Clin Exp Allergy. 2018 Aug;48(8):957-969. doi: 10.1111/cea.13154. Epub 2018 Jun 6.