Clinical trial NCT01823016: A Study of JNJ-38518168 in Symptomatic Adult Participants With Uncontrolled, Persistent Asthma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Uncontrolled, persistent asthma
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2013-04-04
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 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.

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 placebo-controlled (a placebo is identical to the study agent, but contains no active ingredients). A total of 160 participants will receive either placebo or JNJ-38518168 once daily. The study duration will be approximately 32 weeks and will include a screening phase of approximately 4 weeks, a 24-week placebo-controlled treatment phase, and a 4-week follow-up phase. Participant safety will be monitored throughout the entire study period..

Eligibility criteria: 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 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

Primary outcomes:
measure: Change from baseline in prebronchodilator forced expiratory volume in 1 second (preBD FEV1)
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Change from baseline in Asthma Control Questionnaire (ACQ)
timeFrame: Baseline to Week 16
measure: Change from baseline in postbronchodilator forced expiratory volume in 1 second (postBD FEV1)
timeFrame: Baseline to Week 16
measure: Change from baseline in weekly average of daytime asthma diary symptom scores
timeFrame: Baseline to Week 16
measure: Change from baseline in weekly average of nighttime asthma diary symptom scores
timeFrame: Baseline to Week 16
measure: Change from baseline in weekly average of number of puffs in a day that rescue medication is used
timeFrame: Baseline to Week 16
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Mission Viejo
country: United States
state: California
city: San Diego
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Waterbury
country: United States
state: Connecticut
city: Minneapolis
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: Bellevue
country: United States
state: Nebraska
city: Lebanon
country: United States
state: New Hampshire
city: Rochester
country: United States
state: New York
city: Greenville
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Medford
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Altoona
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Calgary
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Hamilton
country: Canada
state: Ontario
city: Kingston
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Sainte Foy
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Montpellier
country: France
city: Berlin
country: Germany
city: Frankfurt
country: Germany
city: Großhansdorf
country: Germany
city: Hannover
country: Germany
city: Koblenz
country: Germany
city: Leipzig
country: Germany
city: Lübeck
country: Germany
city: Magdeburg
country: Germany
city: Mainz
country: Germany
city: Rüdersdorf
country: Germany
city: Ashkelon
country: Israel
city: Haifa
country: Israel
city: Jerusalem
country: Israel
city: Ramat Gan
country: Israel
city: Rehovot
country: Israel
city: Tel Aviv
country: Israel
city: Chertsey
country: United Kingdom
city: Cottingham
country: United Kingdom
city: Dundee
country: United Kingdom
city: Glasgow
country: United Kingdom
city: London
country: United Kingdom
city: Portsmouth
country: United Kingdom
city: Southampton
country: United Kingdom
city: Wolverhampton
country: United Kingdom
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Kollmeier AP, Barnathan ES, O'Brien C, Chen B, Xia YK, Zhou B, Loza MJ, Silkoff PE, Ge M, Thurmond RL. A phase 2a study of toreforant, a histamine H4 receptor antagonist, in eosinophilic asthma. Ann Allergy Asthma Immunol. 2018 Nov;121(5):568-574. doi: 10.1016/j.anai.2018.08.001. Epub 2018 Aug 11.