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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
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Placebo Drug: JNJ-38518168 Phase 2

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..

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Placebo tablet, taken once daily

Experimental: JNJ-38518168 Drug: JNJ-38518168
JNJ-38518168, 30 mg tablet, taken once daily




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Change from baseline in weekly average of number of puffs in a day that rescue medication is used [ Time Frame: Baseline to Week 16 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


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Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01823016     History of Changes
Other Study ID Numbers: CR100976
38518168ASH2001 ( Other Identifier: Janssen Research & Development, LLC )
2012-004920-39 ( EudraCT Number )
First Posted: April 4, 2013    Key Record Dates
Last Update Posted: June 2, 2016
Last Verified: May 2016

Keywords provided by Janssen Research & Development, LLC:
Uncontrolled, persistent asthma

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases