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

NCT01493882 | Withdrawn Phase 2 DMC

• 3 other identifiers: CR10071039758979ASH20022011-003852-37
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma

Keywords

Uncontrolled Persistent Asthma, Dyspnea, Wheezing

Outcome Measures

Primary Outcomes (1)

• The absolute change from baseline in percent-predicted prebronchodilator forced expiratory volume (FEV1) at Week 16 in Part 1 and in Part 2.

  Baseline, Week 16

Secondary Outcomes (5)

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

  Baseline, Week 16

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

  Baseline, Week 16

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

  Baseline, Week 16

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

  Baseline, Week 16

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

  Baseline, Week 16

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

JNJ-39758979 30 mg/d

EXPERIMENTAL

Drug: JNJ-39758979 30 mg/d

JNJ-39758979 100 mg/d

EXPERIMENTAL

Drug: JNJ-39758979 100 mg/d

JNJ-39758979 300 mg/d

EXPERIMENTAL

Drug: JNJ-39758979 300 mg/d

Interventions

Placebo DRUG

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

Placebo

JNJ-39758979 30 mg/d DRUG

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

JNJ-39758979 30 mg/d

JNJ-39758979 100 mg/d DRUG

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

JNJ-39758979 100 mg/d

JNJ-39758979 300 mg/d DRUG

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

JNJ-39758979 300 mg/d

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

MeSH Terms

Conditions

Asthma; Dyspnea; Respiratory Sounds

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: December 16, 2011
• Study Start: March 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: May 14, 2012

Record last verified: 2012-05