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Trial record 63 of 559 for:    Cachectin OR Tumor Necrosis Factor-alpha

TNF-alpha Antagonists for AECOPD: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial

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ClinicalTrials.gov Identifier: NCT00789997
Recruitment Status : Completed
First Posted : November 13, 2008
Results First Posted : April 11, 2016
Last Update Posted : April 11, 2016
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition COPD Exacerbation
Interventions Drug: Prednisone
Drug: Etanercept
Drug: levofloxacin
Enrollment 81
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Etanercept Prednisone
Hide Arm/Group Description Etanercept + Levofloxacin + placebo prednisone capsules : Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later + placebo prednisone capsule, 1 daily for 10 days. Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections : Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days + placebo subcutaneous injections given on day of randomization and one week later.
Period Title: Overall Study
Started 41 40
Completed 40 38
Not Completed 1 2
Arm/Group Title Etanercept Prednisone Total
Hide Arm/Group Description Etanercept + Levofloxacin + placebo prednisone capsules : Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later + placebo prednisone capsule, 1 daily for 10 days. Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections : Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days + placebo subcutaneous injections given on day of randomization and one week later. Total of all reporting groups
Overall Number of Baseline Participants 41 40 81
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 40 participants 81 participants
69.0  (8.6) 65.1  (9.7) 67.1  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 40 participants 81 participants
Female
13
  31.7%
17
  42.5%
30
  37.0%
Male
28
  68.3%
23
  57.5%
51
  63.0%
1.Primary Outcome
Title Change in Lung Function (Forced Expiratory Volume in 1 Second (FEV1)
Hide Description

FEV1 was obtained using calibrated spirometers at approximately the same time of day at all visits throughout the study. The highest acceptable FEV1 and the highest FVC measurement each obtained on any of three blows (even if not from the same curve) meeting the American Thoracic Society criteria constituted the data for that test set.

Not all participants had Day 14 FEV1 measures collected

Time Frame Day 0 to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept Prednisone
Hide Arm/Group Description:
Etanercept + Levofloxacin + placebo prednisone capsules : Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later + placebo prednisone capsule, 1 daily for 10 days.
Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections : Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days + placebo subcutaneous injections given on day of randomization and one week later.
Overall Number of Participants Analyzed 39 37
Mean (Standard Error)
Unit of Measure: percentage of change in FEV1
15.2  (5.7) 20.1  (5.0)
2.Secondary Outcome
Title Number of Participants With Treatment Failure by 90 Days Assignment
Hide Description In the etanercept group 16/40 (40%) failed treatment compared with 12/38 (32%) in the prednisone group.
Time Frame Day 0 to Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept Prednisone
Hide Arm/Group Description:
Etanercept + Levofloxacin + placebo prednisone capsules : Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later + placebo prednisone capsule, 1 daily for 10 days.
Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections : Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days + placebo subcutaneous injections given on day of randomization and one week later.
Overall Number of Participants Analyzed 40 38
Measure Type: Number
Unit of Measure: participants
16 12
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Etanercept Prednisone
Hide Arm/Group Description Etanercept + Levofloxacin + placebo prednisone capsules : Levofloxacin 750 mg daily for 10 days + etanercept 50 mg subcutaneous given on the day of randomization and one week later + placebo prednisone capsule, 1 daily for 10 days. Prednisone + Levofloxacin + placebo Etanercept subcutaneous injections : Levofloxacin 750 mg daily for 10 days + prednisone 40 mg daily for 10 days + placebo subcutaneous injections given on day of randomization and one week later.
All-Cause Mortality
Etanercept Prednisone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Etanercept Prednisone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/41 (9.76%)      7/40 (17.50%)    
Cardiac disorders     
Death [1]  1/41 (2.44%)  1 0/40 (0.00%)  0
Myocardial infarction/unstable angina  1/41 (2.44%)  1 1/40 (2.50%)  1
Gastrointestinal disorders     
Severe Diarrhoea  0/41 (0.00%)  0 1/40 (2.50%)  1
Rectal Occlusion  0/41 (0.00%)  0 1/40 (2.50%)  1
Musculoskeletal and connective tissue disorders     
Fall  1/41 (2.44%)  1 0/40 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pneumonia  0/41 (0.00%)  0 3/40 (7.50%)  3
Pneumothorax  1/41 (2.44%)  1 0/40 (0.00%)  0
Lung Cancer  0/41 (0.00%)  0 1/40 (2.50%)  1
[1]
Cardiopulmonary Arrest
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Etanercept Prednisone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/41 (31.71%)      12/40 (30.00%)    
Blood and lymphatic system disorders     
Hyperglycaemia  0/41 (0.00%)  0 1/40 (2.50%)  1
Musculoskeletal and connective tissue disorders     
Osteomyelitis  0/41 (0.00%)  0 1/40 (2.50%)  1
Achilles Tendonitis  2/41 (4.88%)  2 4/40 (10.00%)  4
Renal and urinary disorders     
Urinary Tract Infection  2/41 (4.88%)  2 2/40 (5.00%)  2
Respiratory, thoracic and mediastinal disorders     
Pneumonia  2/41 (4.88%)  2 0/40 (0.00%)  0
Sinusitis/pharyngitis  3/41 (7.32%)  3 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders     
Leg Oedema  4/41 (9.76%)  4 4/40 (10.00%)  4
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr Shawn Aaron
Organization: The Ottawa Hospital Research Institute
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00789997     History of Changes
Other Study ID Numbers: 2007791-01H
First Submitted: November 12, 2008
First Posted: November 13, 2008
Results First Submitted: June 4, 2013
Results First Posted: April 11, 2016
Last Update Posted: April 11, 2016