Status:
COMPLETED
A Study of the Safety and Effectiveness of JNJ-39758979 in the Treatment of Adults With Persistent Asthma
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of once daily oral administration of JNJ-39758979 in the treatment of adults (18 to 65 years of age) with persistent asthma.
Detailed Description
This is a multicenter, double-blind (neither physician nor participants knows the treatment that the participant receives), randomized (study medication is assigned by chance), placebo-controlled (an ...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of asthma for at least 6 months
- Short-acting beta-agonist use greater than or equal to 5 times in the 2 weeks prior to screening
- Healthy on the basis of physical examination, medical history, vital signs, and 12 lead ECG performed at screening
- Having adequate laboratory values
- No history of/active or latent tuberculosis
- Agree to use protocol defined contraceptive methods
Exclusion
- History of life-threatening asthma attack requiring hospitalization for asthma within 5 years of screening, or emergency department treatment of asthma within the last month
- Moderate or severe renal insufficiency
- Cigarette smoking within the last year - Viral or bacterial vaccination within the last month (eg, FluMist)
- Human Immunodeficiency Virus (HIV) or Hepatitis B or C positive
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00946569
Start Date
August 1 2009
End Date
September 1 2010
Last Update
April 29 2014
Active Locations (24)
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1
Scottsdale, Arizona, United States
2
Cypress, California, United States
3
Los Angeles, California, United States
4
San Diego, California, United States