Study of JNJ-39758979 in Symptomatic Adult Patients With Uncontrolled Asthma
This study has been withdrawn prior to enrollment.
(Study was withdrawn due to 2 cases of agranulocytosis in a different clinical trial with this same drug.)
Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01493882
First received: December 15, 2011
Last updated: May 10, 2012
Last verified: May 2012
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Purpose
The purpose of this study is to evaluate the efficacy, safety and tolerability of JNJ-39758979 compared with placebo in patients with uncontrolled asthma despite current treatment with inhaled corticosteroids and/or long-acting beta 2-agonist (LABA) and/or montelukast for at least 4 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Placebo Drug: JNJ-39758979 30 mg/d Drug: JNJ-39758979 100 mg/d Drug: JNJ-39758979 300 mg/d |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, 2-Part Study of JNJ-39758979 in Symptomatic Adult Subjects With Uncontrolled, Persistent Asthma |
Resource links provided by NLM:
Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Primary Outcome Measures:
- The absolute change from baseline in percent-predicted prebronchodilator forced expiratory volume (FEV1) at Week 16 in Part 1 and in Part 2. [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in Asthma Control Questionnaire (ACQ) at Week 16 in Part 1 and Part 2 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
- Change from baseline in postbronchodilator percent-predicted forced expiratory volume in 1 second (FEV1) at Week 16 in Part 1 and Part 2 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
- Change from baseline in daytime asthma diary symptom score at Week 16 in Part 1 and Part 2 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
- Change from baseline in nighttime asthma diary symptom score at Week 16 in Part 1 and Part 2 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
- Change from baseline in average rescue medication use at Week 16 in Part 1 and Part 2 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: Placebo
Form = tablet, route = oral administration, once daily from Week 0 to Week 24 for Part 1 and Part 2
|
| Experimental: JNJ-39758979 30 mg/d |
Drug: JNJ-39758979 30 mg/d
Unit = mg, number = 30, form = tablet, route = oral administration, once daily from Week 0 to Week 24 only for Part 2
|
| Experimental: JNJ-39758979 100 mg/d |
Drug: JNJ-39758979 100 mg/d
Unit = mg, number = 100, form = tablet, route = oral administration, once daily from Week 0 to Week 24 only for Part 2
|
| Experimental: JNJ-39758979 300 mg/d |
Drug: JNJ-39758979 300 mg/d
Unit = mg, number = 300, form = tablet, route = oral administration, once daily from Week 0 to Week 24 for Part 1 and Part 2
|
Detailed Description:
This is a two-part study; each part of the study (Part 1 and Part 2) will be approximately 34 weeks in duration including a 4-week screening phase, a 24-week placebo-controlled treatment phase and a six-week follow-up phase. In Part 1, patients will be randomly assigned to receive placebo or JNJ-39758979 300 mg once daily through Week 24. In Part 2, patients will be randomly assigned to 1 of 4 treatment groups to receive treatment with placebo, 30 mg, 100 mg, or 300 mg of JNJ-39758979 once daily through Week 24. Safety assessments and evaluations to determine the efficacy of JNJ-39758979 to reduce the signs and symptoms of asthma will be performed both on a daily basis via electronic diary and at study visits.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Has a diagnosis of asthma for at least 6 months before screening. -Has been receiving inhaled corticosteroids (≤ 1000 µg fluticasone or its equivalent) alone or in conjunction with long-acting Beta 2-agonist (salmeterol, formoterol, etc.) and/or montelukast.
- Have an ACQ score ≥ 1.5 at screening. - Must be healthy and medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
- Must be post-menopausal or if pre-menopausal, must use an acceptable method of birth control.
Exclusion Criteria:
- Has ever had a life-threatening asthma attack including respiratory arrest, intubation, or intensive care unit admission due to asthma. -Has a history of any other chronic respiratory condition including chronic obstructive pulmonary disease, bronchiolitis, bronchiectasis, allergic bronchopulmonary aspergillosis (mycosis), occupational asthma, sleep apnea or pulmonary hypertension.-Has initiated or discontinued allergen immunotherapy within 12 weeks of screening. -Has smoked within 3 years of screening or has a history of smoking ≥ 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year) or equivalent, or a positive urine cotinine test at Screening. -Has any known malignancy or has a history of malignancy with the exceptions of basal cell carcinoma or squamous cell carcinoma. -Has chronic or recurrent infectious disease, including, but not limited to: active tuberculosis.-Has a clinically significant, acute respiratory infection within 4 weeks of screening. -Has had a substance abuse (drug or alcohol) problem within the previous 3 years.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01493882
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
| Study Director: | Johnson & Johnson Pharmaceutical Research & Development Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
No publications provided
| Responsible Party: | DIRECTOR CLINICAL DEVELOPMENT, Janssen R&D US |
| ClinicalTrials.gov Identifier: | NCT01493882 History of Changes |
| Other Study ID Numbers: | CR100710, 39758979ASH2002, 2011-003852-37 |
| Study First Received: | December 15, 2011 |
| Last Updated: | May 10, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
|
Uncontrolled Persistent Asthma, Dyspnea, Wheezing |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013