A Study of JNJ-38518168 in Symptomatic Adult Participants With Uncontrolled, Persistent Asthma
NCT ID: NCT01823016
Last Updated: 2025-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
166 participants
INTERVENTIONAL
2013-09-30
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo
Placebo tablet, taken once daily
JNJ-38518168
JNJ-38518168
JNJ-38518168, 30 mg tablet, taken once daily
Interventions
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Placebo
Placebo tablet, taken once daily
JNJ-38518168
JNJ-38518168, 30 mg tablet, taken once daily
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Scottsdale, Arizona, United States
Los Angeles, California, United States
Mission Viejo, California, United States
San Diego, California, United States
Denver, Colorado, United States
Waterbury, Connecticut, United States
Minneapolis, Minnesota, United States
St Louis, Missouri, United States
Bellevue, Nebraska, United States
Lebanon, New Hampshire, United States
Rochester, New York, United States
Greenville, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Medford, Oregon, United States
Portland, Oregon, United States
Altoona, Pennsylvania, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Hamilton, Ontario, Canada
Kingston, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Sainte-Foy, Quebec, Canada
Montpellier, , France
Berlin, , Germany
Frankfurt, , Germany
Großhansdorf, , Germany
Hanover, , Germany
Koblenz, , Germany
Leipzig, , Germany
Lübeck, , Germany
Magdeburg, , Germany
Mainz, , Germany
Rüdersdorf, , Germany
Ashkelon, , Israel
Haifa, , Israel
Jerusalem, , Israel
Ramat Gan, , Israel
Rehovot, , Israel
Tel Aviv, , Israel
Chertsey, , United Kingdom
Cottingham, , United Kingdom
Dundee, , United Kingdom
Glasgow, , United Kingdom
London, , United Kingdom
Portsmouth, , United Kingdom
Southampton, , United Kingdom
Wolverhampton, , United Kingdom
Countries
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References
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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.
Other Identifiers
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38518168ASH2001
Identifier Type: OTHER
Identifier Source: secondary_id
2012-004920-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR100976
Identifier Type: -
Identifier Source: org_study_id
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