Effectiveness and Safety Study for JNJ-18054478 in Asthma Patients.

This study has been terminated.
(Lack of efficacy following an interim analysis)
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00530166
First received: September 13, 2007
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to assess the effectiveness of JNJ-18054478 measured by the percent change from baseline in Forced Expiratory Volume in one Second (FEV1) after 12 weeks of therapy in patients with persistent asthma.


Condition Intervention Phase
Asthma
Drug: JNJ-18054478
Drug: sham comparator
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Investigate the Effect of JNJ-18054478 in Subjects With Asthma

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • The percent change from the beginning of the study in Forced Expiratory Volume in one Second (FEV1) after 12 weeks on study drug. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The change in FEV1 after 1, 2, 4, 6, 8 and 10 weeks therapy. The change in symptoms and use of asthma rescue medication. The number of asthma attacks compared to placebo. The safety, tolerability, and blood and urine levels of JNJ-18054478 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 26
Study Start Date: July 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 002
sham comparator 3(100 mg) tablets once daily for 12 weeks
Drug: sham comparator
3(100 mg) tablets once daily for 12 weeks
Experimental: 001
JNJ-18054478 3(100 mg) tablets once daily for 12 weeks
Drug: JNJ-18054478
3(100 mg) tablets once daily for 12 weeks

Detailed Description:

Asthma is one of the most common chronic diseases worldwide. This is a randomized (study medication assigned by chance), double-blind study (neither the physician or the patient knows which drug they are receiving, active or placebo) to Investigate the effectiveness and safety of 12 weeks of dosing with JNJ-18054478 (300 mg taken orally once daily) compared with placebo in patients with persistent asthma. The hypothesis is that the study drug will be more effective in treatment of asthma than placebo as measured by the percent change from baseline in Forced Expiratory Volume in one Second (FEV1) after 12 weeks of therapy, without any significant adverse events. Safety evaluations will include, monitoring for adverse reactions, clinical laboratory tests of blood and urine, ECGs to monitor the cardiovascular system, vital signs and physical examinations. Patients will take three capsules (100 mg) of JNJ-18054478 orally once daily for 12 weeks or placebo for the same period.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Medically confirmed diagnosis of persistent asthma
  • Able to demonstrate reversibility of at least 12% with albuterol inhalation
  • Use of short-acting b-2 agonists for rescue >= 5 times within 2 weeks prior
  • Able to produce an FEV1 between 45 and 85% of predicted
  • Willing to perform study procedures for about 14 weeks.

Exclusion Criteria:

  • Use of inhaled corticosteroids within 4 weeks
  • Use of oral/parenteral corticosteroids within 8 weeks
  • Use of long-acting beta-2 agonists or montelukast within 2 weeks
  • History of life-threatening asthma attack within 3 months
  • Female of child bearing potential.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530166

  Show 36 Study Locations
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00530166     History of Changes
Other Study ID Numbers: CR013087, 18054478NAP2002
Study First Received: September 13, 2007
Last Updated: June 3, 2014
Health Authority: United States: Food and Drug Administration
India: Ministry of Health

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Asthma
persistant asthma
controller medications
FEV1

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 September 22, 2014