Status:
COMPLETED
A Study of Safety and Efficacy of CNTO 148 in Patients With Severe Persistent Asthma
Lead Sponsor:
Centocor, Inc.
Collaborating Sponsors:
Centocor BV
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of CNTO 148 (golimumab) in patients with severe persistent asthma.
Detailed Description
This is a multicenter, randomized (the study medication is assigned by chance), double-blind (neither physician nor patient knows the treatment that the patient receives), placebo-controlled (an inact...
Eligibility Criteria
Inclusion
- Physician diagnosis of asthma for greater than or equal to 3 years and a diagnosis of severe persistent asthma forgreater than or equal to 1 year prior to screening
- Continuous treatment with high dose Inhaled corticosteroids (ICS) and long acting beta-agonist for at least 3 months prior to screening
- Have evidence of at least 1 of the following in the 5 years prior to screening or during screening, reversible airway obstruction greater than or equal to 12 percentage change in forced expiratory volume in 1 second (FEV1) postbronchodilator; Diurnal variation in peak expiratory flow rate (PEFR) greater than or equal to 30 percentage change) and airway hyperresponsiveness
- Estimated frequency of symptoms on more than one-third of days for at least 3 months prior to screening (eg, wheezing, breathlessness, chest tightness, cough, nocturnal awakening) despite treatment with high dose ICS and long-acting β2-agonist (LABA), with or without continuous oral corticosteroids
- Score of greater than or equal to 2 points on the asthma control questionnaire at screening.
Exclusion
- Diagnosis of chronic obstructive pulmoanry disease (COPD), cystic fibrosis, or other significant respiratory disorder
- Worsening of asthma symptoms that required treatment with an addition or increase in oral corticosteroids dose (steroid burst) in the 4-week period prior to the screening visit
- Life-threatening asthma attack requiring cardiopulmonary support (eg, intubation) in the 6-month period prior to screening
- Have ever used alkylating agents (eg, chlorambucil or cyclophosphamide)
- Concomitant diagnosis or any history of congestive heart failure (CHF), including medically controlled CHF.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
309 Patients enrolled
Trial Details
Trial ID
NCT00207740
Start Date
August 1 2004
End Date
July 1 2007
Last Update
August 20 2012
Active Locations (57)
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1
Los Angeles, California, United States
2
San Diego, California, United States
3
Stockton, California, United States
4
Denver, Colorado, United States