A Study of Safety and Efficacy of CNTO 148 in Patients With Severe Persistent Asthma
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|ClinicalTrials.gov Identifier: NCT00207740|
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : June 1, 2012
Last Update Posted : August 20, 2012
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: CNTO148 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||309 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 Start Date :||August 2004|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||July 2007|
|Experimental: CNTO 148 (golimumab)||
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 Comparator: Placebo||
Type=exact type, unit=mg, form=injection, route=subcutaneous. Placebo will be given from from Week 0 through Week 52.
- Change From Baseline in Prebronchodilator Clinic-Measured, Percent-Predicted Forced Expiratory Volume in 1 Second [ Time Frame: Baseline and Week 24 ]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 [ Time Frame: Baseline to Week 24 ]The endpoint is the average number of severe asthma exacerbations per patient from baseline through 6 months.
- Change From Baseline in Asthma Quality of Life Questionnaire Score at 6 Months; Randomized Patients [ Time Frame: Baseline to Week 24 ]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 [ Time Frame: Baseline to Week 24 ]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 [ Time Frame: Week 24 to Week 52 ]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 [ Time Frame: Baseline and Week 52 ]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 [ Time Frame: Baseline to Week 24 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00207740
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|Study Director:||Centocor, Inc. Clinical Trial||Centocor, Inc.|