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Study of JNJ-39758979 in Symptomatic Adult Patients With Uncontrolled Asthma

Primary Purpose

Asthma

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Placebo

JNJ-39758979 30 mg/d

JNJ-39758979 100 mg/d

JNJ-39758979 300 mg/d

About this trial

This is an interventional treatment trial for Asthma focused on measuring Uncontrolled Persistent Asthma, Dyspnea, Wheezing

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

JNJ-39758979 30 mg/d

JNJ-39758979 100 mg/d

JNJ-39758979 300 mg/d

Arm Description

Outcomes

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.

Secondary Outcome Measures

Change from baseline in Asthma Control Questionnaire (ACQ) at Week 16 in Part 1 and Part 2

Change from baseline in postbronchodilator percent-predicted forced expiratory volume in 1 second (FEV1) at Week 16 in Part 1 and Part 2

Change from baseline in daytime asthma diary symptom score at Week 16 in Part 1 and Part 2

Change from baseline in nighttime asthma diary symptom score at Week 16 in Part 1 and Part 2

Change from baseline in average rescue medication use at Week 16 in Part 1 and Part 2

Full Information

NCT ID

NCT01493882

First Posted

December 15, 2011

Last Updated

May 10, 2012

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

1. Study Identification

Unique Protocol Identification Number

NCT01493882

Brief Title

Study of JNJ-39758979 in Symptomatic Adult Patients With Uncontrolled Asthma

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Withdrawn

Why Stopped

Study was withdrawn due to 2 cases of agranulocytosis in a different clinical trial with this same drug.

Study Start Date

March 2012 (undefined)

Primary Completion Date

June 2015 (Anticipated)

Study Completion Date

June 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Uncontrolled Persistent Asthma, Dyspnea, Wheezing

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

JNJ-39758979 30 mg/d

Arm Type

Experimental

Arm Title

JNJ-39758979 100 mg/d

Arm Type

Experimental

Arm Title

JNJ-39758979 300 mg/d

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Form = tablet, route = oral administration, once daily from Week 0 to Week 24 for Part 1 and Part 2

Intervention Type

Drug

Intervention Name(s)

JNJ-39758979 30 mg/d

Intervention Description

Unit = mg, number = 30, form = tablet, route = oral administration, once daily from Week 0 to Week 24 only for Part 2

Intervention Type

Drug

Intervention Name(s)

JNJ-39758979 100 mg/d

Intervention Description

Unit = mg, number = 100, form = tablet, route = oral administration, once daily from Week 0 to Week 24 only for Part 2

Intervention Type

Drug

Intervention Name(s)

JNJ-39758979 300 mg/d

Intervention Description

Unit = mg, number = 300, form = tablet, route = oral administration, once daily from Week 0 to Week 24 for Part 1 and Part 2

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Change from baseline in Asthma Control Questionnaire (ACQ) at Week 16 in Part 1 and Part 2

Time Frame

Baseline, Week 16

Title

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

Title

Change from baseline in daytime asthma diary symptom score at Week 16 in Part 1 and Part 2

Time Frame

Baseline, Week 16

Title

Change from baseline in nighttime asthma diary symptom score at Week 16 in Part 1 and Part 2

Time Frame

Baseline, Week 16

Title

Change from baseline in average rescue medication use at Week 16 in Part 1 and Part 2

Time Frame

Baseline, Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Johnson & Johnson Pharmaceutical Research & Development Development, L.L.C. Clinical Trial

Organizational Affiliation

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

Study of JNJ-39758979 in Symptomatic Adult Patients With Uncontrolled Asthma

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