Back to resultsA Study of JNJ-38518168 in Symptomatic Adult Participants With Uncontrolled, Persistent Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
JNJ-38518168
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Uncontrolled, persistent asthma
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
JNJ-38518168
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in prebronchodilator forced expiratory volume in 1 second (preBD FEV1)
Expressed as percent of predicted value.
Secondary Outcome Measures
Change from baseline in Asthma Control Questionnaire (ACQ)
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)
Expressed as percent of predicted value.
Change from baseline in weekly average of daytime asthma diary symptom scores
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
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
Full Information
NCT ID
NCT01823016
First Posted
March 28, 2013
Last Updated
May 3, 2016
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT01823016
Brief Title
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
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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..
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Uncontrolled, persistent asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
166 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
JNJ-38518168
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet, taken once daily
Intervention Type
Drug
Intervention Name(s)
JNJ-38518168
Intervention Description
JNJ-38518168, 30 mg tablet, taken once daily
Primary Outcome Measure Information:
Title
Change from baseline in prebronchodilator forced expiratory volume in 1 second (preBD FEV1)
Description
Expressed as percent of predicted value.
Time Frame
Baseline to Week 16
Secondary Outcome Measure Information:
Title
Change from baseline in Asthma Control Questionnaire (ACQ)
Description
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.
Time Frame
Baseline to Week 16
Title
Change from baseline in postbronchodilator forced expiratory volume in 1 second (postBD FEV1)
Description
Expressed as percent of predicted value.
Time Frame
Baseline to Week 16
Title
Change from baseline in weekly average of daytime asthma diary symptom scores
Description
Asthma diaries include questions about the frequency/severity of symptoms and impact on activities. Higher scores indicate more asthma symptoms.
Time Frame
Baseline to Week 16
Title
Change from baseline in weekly average of nighttime asthma diary symptom scores
Description
Asthma diaries include questions about number of nocturnal awakenings.
Time Frame
Baseline to Week 16
Title
Change from baseline in weekly average of number of puffs in a day that rescue medication is used
Time Frame
Baseline to Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Scottsdale
State/Province
Arizona
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Mission Viejo
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Waterbury
State/Province
Connecticut
Country
United States
City
Minneapolis
State/Province
Minnesota
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Bellevue
State/Province
Nebraska
Country
United States
City
Lebanon
State/Province
New Hampshire
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Greenville
State/Province
North Carolina
Country
United States
City
Winston Salem
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Medford
State/Province
Oregon
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Altoona
State/Province
Pennsylvania
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Calgary
State/Province
Alberta
Country
Canada
City
Vancouver
State/Province
British Columbia
Country
Canada
City
Hamilton
State/Province
Ontario
Country
Canada
City
Kingston
State/Province
Ontario
Country
Canada
City
Ottawa
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
City
Sainte Foy
State/Province
Quebec
Country
Canada
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
30102965
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.
Results Reference
derived
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A Study of JNJ-38518168 in Symptomatic Adult Participants With Uncontrolled, Persistent Asthma
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