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

NCT ID: NCT00207740

Last Updated: 2012-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 309 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2007-07-31

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 inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical study), parallel-group (each group of patients will be treated at the same time), dose-ranging study to evaluate the efficacy and safety of CNTO 148. The study will consists of run-in phase (2 weeks), treatment period (52 weeks) and follow up period (24 weeks). The patients inhaled corticosteroids (ICS) medication will be standardized in the run-in phase and the treatment period contains first 24 weeks of treatment, the patients are required to remain on stable doses of concomitant corticosteroids (CS) medication (steroid stable phase). The steroid stable phase is followed by a 28-week steroid taper phase, during which a reduction of concomitant CS medication will be attempted. After completion of the study treatment, patients are to be followed for an additional 24 weeks. Patients will receive subcutaneous injections of 75, 150, or 300 mg of CNTO 148 or placebo every 4 weeks for 52 weeks followed 50,100, or 200 mg every 4 weeks through week 52. The safety of the patient will be monitored throughout the study.

Conditions

Asthma

Keywords

Asthma; Severe Persistent Asthma; Subcutaneous injections; Immunology disorder; Breathlesness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CNTO 148 (golimumab)

Group Type: EXPERIMENTAL

CNTO148

Intervention Type: DRUG

Type=exact type, unit=mg, number=50, 75, 100, 150, 200 and 300, form=injection, route=subcutaneous. Every 4 weeks partciapnts will receive injections in 4 parallel treatment arms

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Type=exact type, unit=mg, form=injection, route=subcutaneous. Placebo will be given from from Week 0 through Week 52.

Interventions

CNTO148

Type=exact type, unit=mg, number=50, 75, 100, 150, 200 and 300, form=injection, route=subcutaneous. Every 4 weeks partciapnts will receive injections in 4 parallel treatment arms

Intervention Type: DRUG

Placebo

Type=exact type, unit=mg, form=injection, route=subcutaneous. Placebo will be given from from Week 0 through Week 52.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centocor BV

INDUSTRY

Sponsor Role: collaborator

Centocor, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Centocor, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Centocor, Inc.

Locations

Los Angeles, California, United States

San Diego, California, United States

Stockton, California, United States

Denver, Colorado, United States

Hartford, Connecticut, United States

New Haven, Connecticut, United States

Chicago, Illinois, United States

Normal, Illinois, United States

River Forest, Illinois, United States

Iowa City, Iowa, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

North Dartmouth, Massachusetts, United States

Minneapolis, Minnesota, United States

St Louis, Missouri, United States

Cortland, New York, United States

Elmira, New York, United States

Charlotte, North Carolina, United States

Winston-Salem, North Carolina, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Lake Oswego, Oregon, United States

Medford, Oregon, United States

Portland, Oregon, United States

Philadelphia, Pennsylvania, United States

El Paso, Texas, United States

Richmond, Virginia, United States

Bellingham, Washington, United States

Madison, Wisconsin, United States

Ghent, , Belgium

Russel, , Bulgaria

Sofia, , Bulgaria

Ostrava, , Czechia

Poruba, , Czechia

Ústí nad Labem, , Czechia

Montpellier, , France

Pessac, , France

Tarbes, , France

Berlin, , Germany

Großhansdorf, , Germany

Leipzig, , Germany

Mainz, , Germany

Budapest, , Hungary

Nyíregyháza, , Hungary

Székesfehérvár, , Hungary

Szombathely, , Hungary

Törökbálint, , Hungary

Leiden, , Netherlands

Bieńkówka, , Poland

Katowice, , Poland

Lodz, , Poland

Torun, , Poland

Warsaw, , Poland

Linköping, , Sweden

Stockholm, , Sweden

Glasgow, , United Kingdom

Southampton, , United Kingdom

Countries

Italy; United States; Belgium; Bulgaria; Czechia; France; Germany; Hungary; Netherlands; Poland; Sweden; United Kingdom

References

Wenzel SE, Barnes PJ, Bleecker ER, Bousquet J, Busse W, Dahlen SE, Holgate ST, Meyers DA, Rabe KF, Antczak A, Baker J, Horvath I, Mark Z, Bernstein D, Kerwin E, Schlenker-Herceg R, Lo KH, Watt R, Barnathan ES, Chanez P; T03 Asthma Investigators. A randomized, double-blind, placebo-controlled study of tumor necrosis factor-alpha blockade in severe persistent asthma. Am J Respir Crit Care Med. 2009 Apr 1;179(7):549-58. doi: 10.1164/rccm.200809-1512OC. Epub 2009 Jan 8.

Reference Type: DERIVED

PMID: 19136369 (View on PubMed)

Other Identifiers

C0524T03

Identifier Type: OTHER

Identifier Source: secondary_id

CR005281

Identifier Type: -

Identifier Source: org_study_id