A Study of Safety and Efficacy of CNTO 148 in Patients With Severe Persistent Asthma

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

The purpose of this study is to evaluate the effectiveness and safety of CNTO 148 (golimumab) in patients with severe persistent asthma.

Key facts

Study ID

NCT00207740

Run by

Centocor, Inc.

People needed

309

Starts

2004-08-01

Expected to finish

2007-07-01

Last updated by the study team

2012-08-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — San Diego, California, United States
• Study site — Stockton, California, United States
• Study site — Denver, Colorado, United States
• Study site — Hartford, Connecticut, United States
• Study site — New Haven, Connecticut, United States
• Study site — Chicago, Illinois, United States
• Study site — Normal, Illinois, United States
• Study site — River Forest, Illinois, United States
• Study site — Iowa City, Iowa, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — North Dartmouth, Massachusetts, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — Cortland, New York, United States
• Study site — Elmira, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Lake Oswego, Oregon, United States
• Study site — Medford, Oregon, United States
• Study site — Portland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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