Effectiveness and Safety Study for JNJ-18054478 in Asthma Patients.
NCT ID: NCT00530166
Last Updated: 2014-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
26 participants
INTERVENTIONAL
2007-07-31
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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002
sham comparator 3(100 mg) tablets once daily for 12 weeks
sham comparator
3(100 mg) tablets once daily for 12 weeks
001
JNJ-18054478 3(100 mg) tablets once daily for 12 weeks
JNJ-18054478
3(100 mg) tablets once daily for 12 weeks
Interventions
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JNJ-18054478
3(100 mg) tablets once daily for 12 weeks
sham comparator
3(100 mg) tablets once daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
Responsible Party
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Principal Investigators
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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Role: STUDY_DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Locations
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Scottsdale, Arizona, United States
Long Beach, California, United States
Los Angeles, California, United States
Paramount, California, United States
San Jose, California, United States
Colorado Springs, Colorado, United States
Pueblo, Colorado, United States
Chicago, Illinois, United States
Normal, Illinois, United States
River Forest, Illinois, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
North Dartmouth, Massachusetts, United States
Plymouth, Minnesota, United States
St Louis, Missouri, United States
Skillman, New Jersey, United States
North Syracuse, New York, United States
Rochester, New York, United States
Canton, Ohio, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Lake Oswego, Oregon, United States
Medford, Oregon, United States
Portland, Oregon, United States
Chester, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Dallas, Texas, United States
Madison, Wisconsin, United States
San José, , Costa Rica
Bangalore, , India
Chennai, , India
Hyderabad, , India
Mumbai, , India
Mysore, , India
Vellore, , India
Countries
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Other Identifiers
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18054478NAP2002
Identifier Type: -
Identifier Source: secondary_id
CR013087
Identifier Type: -
Identifier Source: org_study_id
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