Study Stopped
Lack of efficacy following an interim analysis
Effectiveness and Safety Study for JNJ-18054478 in Asthma Patients.
A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Investigate the Effect of JNJ-18054478 in Subjects With Asthma
2 other identifiers
interventional
26
3 countries
36
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 asthma
Started Jul 2007
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 13, 2007
CompletedFirst Posted
Study publicly available on registry
September 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedJune 18, 2014
June 1, 2014
1 year
September 13, 2007
June 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The percent change from the beginning of the study in Forced Expiratory Volume in one Second (FEV1) after 12 weeks on study drug.
12 weeks
Secondary Outcomes (1)
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
12 weeks
Study Arms (2)
002
EXPERIMENTALsham comparator 3(100 mg) tablets once daily for 12 weeks
001
EXPERIMENTALJNJ-18054478 3(100 mg) tablets once daily for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Unknown Facility
Scottsdale, Arizona, United States
Unknown Facility
Long Beach, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Paramount, California, United States
Unknown Facility
San Jose, California, United States
Unknown Facility
Colorado Springs, Colorado, United States
Unknown Facility
Pueblo, Colorado, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Normal, Illinois, United States
Unknown Facility
River Forest, Illinois, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
North Dartmouth, Massachusetts, United States
Unknown Facility
Plymouth, Minnesota, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Skillman, New Jersey, United States
Unknown Facility
North Syracuse, New York, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Canton, Ohio, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Tulsa, Oklahoma, United States
Unknown Facility
Lake Oswego, Oregon, United States
Unknown Facility
Medford, Oregon, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Chester, Pennsylvania, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Madison, Wisconsin, United States
Unknown Facility
San José, Costa Rica
Unknown Facility
Bangalore, India
Unknown Facility
Chennai, India
Unknown Facility
Hyderabad, India
Unknown Facility
Mumbai, India
Unknown Facility
Mysore, India
Unknown Facility
Vellore, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2007
First Posted
September 17, 2007
Study Start
July 1, 2007
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
June 18, 2014
Record last verified: 2014-06