Overview

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

Status:
Completed
Trial end date:
2007-07-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the effectiveness and safety of CNTO 148 (golimumab) in patients with severe persistent asthma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Centocor, Inc.
Collaborator:
Centocor BV
Treatments:
Golimumab
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.