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

NCT00207740 | Completed Phase 2 Results DMC

• 2 other identifiers: CR005281C0524T03
• Study Type: interventional
• Target: 309
• Locations: 11 countries
• Sites: 57

Brief Summary

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

Conditions

Asthma

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Prebronchodilator Clinic-Measured, Percent-Predicted Forced Expiratory Volume in 1 Second

  The endpoint is change from baseline in prebronchodilator clinic-measured percent predicted Percent-Predicted Forced Expiratory Volume in 1 Second (FEV1) with Last Observation Carried Forward (LOCF) at 6 months. The baseline visit starts at the end of 2 weeks run in phase.

  Baseline and Week 24

• Number of Severe Asthma Exacerbations Per Patient From Baseline Through 6 Months

  The endpoint is the average number of severe asthma exacerbations per patient from baseline through 6 months.

  Baseline to Week 24

Secondary Outcomes (5)

• Change From Baseline in Asthma Quality of Life Questionnaire Score at 6 Months; Randomized Patients

  Baseline to Week 24

• Change From Baseline in Rescue Medication Use at 6 Months; Randomized Patients

  Baseline to Week 24

• Number of Severe Asthma Exacerbations Per Patient From Week 24 Through Week 52; Randomized Patients Who Did Not Discontinue Study Participation Prior to Week 24

  Week 24 to Week 52

• Change From Baseline in Oral Corticosteroids Dose at Week 52; Randomized Patients Who Received Oral Corticosteroids at Baseline

  Baseline and Week 52

• Change From Baseline in Domiciliary Morning Peak Expiratory Flow Rate (PEFR) at 6 Months; Randomized Subjects

  Baseline to Week 24

Study Arms (2)

CNTO 148 (golimumab)

EXPERIMENTAL

Drug: CNTO148

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CNTO148 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

CNTO 148 (golimumab)

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Centocor, Inc.: lead
• Centocor BV: collaborator

Study Sites (57)

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Los Angeles, California, United States

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San Diego, California, United States

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Stockton, California, United States

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Denver, Colorado, United States

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Hartford, Connecticut, United States

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New Haven, Connecticut, United States

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Chicago, Illinois, United States

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Normal, Illinois, United States

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River Forest, Illinois, United States

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Iowa City, Iowa, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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North Dartmouth, Massachusetts, United States

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Minneapolis, Minnesota, United States

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St Louis, Missouri, United States

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Cortland, New York, United States

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Elmira, New York, United States

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Charlotte, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Lake Oswego, Oregon, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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El Paso, Texas, United States

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Richmond, Virginia, United States

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Bellingham, Washington, United States

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Madison, Wisconsin, United States

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Ghent, Belgium

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Russel, Bulgaria

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Sofia, Bulgaria

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Ostrava, Czechia

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Poruba, Czechia

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Ústí nad Labem, Czechia

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Montpellier, France

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Pessac, France

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Tarbes, France

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Berlin, Germany

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Großhansdorf, Germany

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Leipzig, Germany

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Mainz, Germany

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Budapest, Hungary

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Nyíregyháza, Hungary

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Székesfehérvár, Hungary

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Szombathely, Hungary

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Törökbálint, Hungary

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Leiden, Netherlands

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Bieńkówka, Poland

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Katowice, Poland

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Lodz, Poland

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Torun, Poland

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Warsaw, Poland

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Linköping, Sweden

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Stockholm, Sweden

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Glasgow, United Kingdom

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Southampton, United Kingdom

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Related Publications (1)

• 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.

  PMID: 19136369 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

golimumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

The count of patients with any nonserious adverse events (NAE) excludes patients who only had NAE that occurred in \<= 5% of patients. This information may vary from existing approved labeling and publications due to the requirement of this website.

Results Point of Contact

• Title: Director Clinical Research
• Organization: Centocor Research & Development, Inc.

1-800-457-6399

Study Officials

• Centocor, Inc. Clinical Trial

  Centocor, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: August 1, 2004
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: August 20, 2012
• Results First Posted: June 1, 2012

Record last verified: 2012-08

Locations

FR (3); US (29); SE (2); GB (2); CZ (3); PL (5); NL (1); BU (2); DE (4); HU (5); BE (1)