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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01493882
• Other study ID #: CR100710
• Secondary ID: 39758979ASH20022
• Status: Withdrawn
• Phase: Phase 2
• First received: December 15, 2011
• Last updated: May 10, 2012
• Start date: March 2012
• Est. completion date: June 2015

Study information

• Verified date: May 2012
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change from baseline in Asthma Control Questionnaire (ACQ) at Week 16 in Part 1 and Part 2		Baseline, Week 16	No
Secondary	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	No
Secondary	Change from baseline in daytime asthma diary symptom score at Week 16 in Part 1 and Part 2		Baseline, Week 16	No
Secondary	Change from baseline in nighttime asthma diary symptom score at Week 16 in Part 1 and Part 2		Baseline, Week 16	No
Secondary	Change from baseline in average rescue medication use at Week 16 in Part 1 and Part 2		Baseline, Week 16	No