Back to resultsA Study of Safety and Efficacy of CNTO 148 in Patients With Severe Persistent Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CNTO148
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma, Severe Persistent Asthma, Subcutaneous injections, Immunology disorder, Breathlesness
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CNTO 148 (golimumab)
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Change From Baseline in Asthma Quality of Life Questionnaire Score at 6 Months; Randomized Patients
The endpoint is the change from baseline in the overall Asthma Quality of Life Questionnaire (AQLQ) score at 6 months. The AQLQ is a validated and self-administered questionnaire to evaluate symptoms and Quality of Life (QOL) in subjects with asthma and it has 32 questions in 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants were asked to score the importance of each of the positively identified problems on a 7-point scale (7 = not impaired at all - 1 = severely impaired).
Change From Baseline in Rescue Medication Use at 6 Months; Randomized Patients
The endpoint is change from baseline in rescue medication use at Wk 24 where the rescue medication use was based on the average over 7 days prior to visit.
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
The endpoint is the average number of severe asthma exacerbations per patient from Week (Wk) 24 through Wk 52 for the patients who did not discontinue study participation prior to Wk 24
Change From Baseline in Oral Corticosteroids Dose at Week 52; Randomized Patients Who Received Oral Corticosteroids at Baseline
The endpoint is the change from baseline at Week (Wk) 52 in oral corticosteroids (OCS) dose for the randomized patients who received OCS at baseline.
Change From Baseline in Domiciliary Morning Peak Expiratory Flow Rate (PEFR) at 6 Months; Randomized Subjects
The endpoint is the change from baseline in domiciliary morning PEFR at Week 24. PEFR- Peak Expiratory Flow Rate (PEFR): A measure of the speed of exhalation. The data were collected in the eDiary which was issued to each participant at screening. PEFR was collected morning and evening each day of the study.
Full Information
NCT ID
NCT00207740
First Posted
September 13, 2005
Last Updated
August 14, 2012
Sponsor
Centocor, Inc.
Collaborators
Centocor BV
1. Study Identification
Unique Protocol Identification Number
NCT00207740
Brief Title
A Study of Safety and Efficacy of CNTO 148 in Patients With Severe Persistent Asthma
Official Title
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 148 Administered Subcutaneously in Symptomatic Subjects With Severe Persistent Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centocor, Inc.
Collaborators
Centocor BV
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Severe Persistent Asthma, Subcutaneous injections, Immunology disorder, Breathlesness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
309 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CNTO 148 (golimumab)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CNTO148
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Type=exact type, unit=mg, form=injection, route=subcutaneous. Placebo will be given from from Week 0 through Week 52.
Primary Outcome Measure Information:
Title
Change From Baseline in Prebronchodilator Clinic-Measured, Percent-Predicted Forced Expiratory Volume in 1 Second
Description
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.
Time Frame
Baseline and Week 24
Title
Number of Severe Asthma Exacerbations Per Patient From Baseline Through 6 Months
Description
The endpoint is the average number of severe asthma exacerbations per patient from baseline through 6 months.
Time Frame
Baseline to Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline in Asthma Quality of Life Questionnaire Score at 6 Months; Randomized Patients
Description
The endpoint is the change from baseline in the overall Asthma Quality of Life Questionnaire (AQLQ) score at 6 months. The AQLQ is a validated and self-administered questionnaire to evaluate symptoms and Quality of Life (QOL) in subjects with asthma and it has 32 questions in 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants were asked to score the importance of each of the positively identified problems on a 7-point scale (7 = not impaired at all - 1 = severely impaired).
Time Frame
Baseline to Week 24
Title
Change From Baseline in Rescue Medication Use at 6 Months; Randomized Patients
Description
The endpoint is change from baseline in rescue medication use at Wk 24 where the rescue medication use was based on the average over 7 days prior to visit.
Time Frame
Baseline to Week 24
Title
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
Description
The endpoint is the average number of severe asthma exacerbations per patient from Week (Wk) 24 through Wk 52 for the patients who did not discontinue study participation prior to Wk 24
Time Frame
Week 24 to Week 52
Title
Change From Baseline in Oral Corticosteroids Dose at Week 52; Randomized Patients Who Received Oral Corticosteroids at Baseline
Description
The endpoint is the change from baseline at Week (Wk) 52 in oral corticosteroids (OCS) dose for the randomized patients who received OCS at baseline.
Time Frame
Baseline and Week 52
Title
Change From Baseline in Domiciliary Morning Peak Expiratory Flow Rate (PEFR) at 6 Months; Randomized Subjects
Description
The endpoint is the change from baseline in domiciliary morning PEFR at Week 24. PEFR- Peak Expiratory Flow Rate (PEFR): A measure of the speed of exhalation. The data were collected in the eDiary which was issued to each participant at screening. PEFR was collected morning and evening each day of the study.
Time Frame
Baseline to Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Centocor, Inc. Clinical Trial
Organizational Affiliation
Centocor, Inc.
Official's Role
Study Director
Facility Information:
City
Los Angeles
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California
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United States
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San Diego
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United States
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Stockton
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Denver
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Hartford
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New Haven
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Chicago
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Normal
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River Forest
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Iowa City
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Baltimore
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Boston
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North Dartmouth
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Minneapolis
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Saint Louis
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St. Louis
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Missouri
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Cortland
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New York
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United States
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Elmira
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Charlotte
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Winston-Salem
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Cincinnati
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Cleveland
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Lake Oswego
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Medford
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Portland
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Philadelphia
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El Paso
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Richmond
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Virginia
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Bellingham
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Washington
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Madison
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Wisconsin
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Gent
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Belgium
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Russel
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Bulgaria
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Sofia
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Bulgaria
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Ostrava
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Czech Republic
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Poruba
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Czech Republic
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Usti Nad Labem
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Czech Republic
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Montpellier Cedex 9
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France
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Pessac
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France
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Tarbes
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France
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Berlin
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Germany
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Großhansdorf
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Germany
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Leipzig
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Germany
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Mainz
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Germany
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Budapest
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Hungary
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Nyiregyhaza
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Hungary
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Szekesfehervar
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Hungary
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Szombathely
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Hungary
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Törökbálint
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Hungary
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Leiden
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Netherlands
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Bienkowka
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Poland
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Katowice
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Poland
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Lodz
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Poland
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Torun
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Poland
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Warszawa
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Poland
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Linkoeping
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Sweden
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Stockholm
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Sweden
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Glasgow
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United Kingdom
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Southampton
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
19136369
Citation
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.
Results Reference
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A Study of Safety and Efficacy of CNTO 148 in Patients With Severe Persistent Asthma
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