Trial Outcomes & Findings for TNF-alpha Antagonists for AECOPD: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial (NCT NCT00789997)
NCT ID: NCT00789997
Last Updated: 2016-04-11
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
81 participants
Primary outcome timeframe
Day 0 to Day 14
Results posted on
2016-04-11
Participant Flow
Participant milestones
| Measure |
Etanercept
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
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 Study
STARTED
|
41
|
40
|
|
Overall Study
COMPLETED
|
40
|
38
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TNF-alpha Antagonists for AECOPD: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial
Baseline characteristics by cohort
| Measure |
Etanercept
n=41 Participants
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
n=40 Participants
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
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.0 years
STANDARD_DEVIATION 8.6 • n=99 Participants
|
65.1 years
STANDARD_DEVIATION 9.7 • n=107 Participants
|
67.1 years
STANDARD_DEVIATION 9.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Day 14FEV1 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
Outcome measures
| Measure |
Etanercept
n=39 Participants
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
n=37 Participants
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.
|
|---|---|---|
|
Change in Lung Function (Forced Expiratory Volume in 1 Second (FEV1)
|
15.2 percentage of change in FEV1
Standard Error 5.7
|
20.1 percentage of change in FEV1
Standard Error 5.0
|
SECONDARY outcome
Timeframe: Day 0 to Day 90In the etanercept group 16/40 (40%) failed treatment compared with 12/38 (32%) in the prednisone group.
Outcome measures
| Measure |
Etanercept
n=40 Participants
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
n=38 Participants
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.
|
|---|---|---|
|
Number of Participants With Treatment Failure by 90 Days Assignment
|
16 participants
|
12 participants
|
Adverse Events
Etanercept
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Prednisone
Serious events: 7 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Etanercept
n=41 participants at risk
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
n=40 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Death
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/41
|
7.5%
3/40 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Lung Cancer
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fall
|
2.4%
1/41 • Number of events 1
|
0.00%
0/40
|
|
Cardiac disorders
Myocardial infarction/unstable angina
|
2.4%
1/41 • Number of events 1
|
2.5%
1/40 • Number of events 1
|
|
Gastrointestinal disorders
Severe Diarrhoea
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
|
Gastrointestinal disorders
Rectal Occlusion
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
Other adverse events
| Measure |
Etanercept
n=41 participants at risk
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
n=40 participants at risk
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.9%
2/41 • Number of events 2
|
0.00%
0/40
|
|
Renal and urinary disorders
Urinary Tract Infection
|
4.9%
2/41 • Number of events 2
|
5.0%
2/40 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis/pharyngitis
|
7.3%
3/41 • Number of events 3
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Leg Oedema
|
9.8%
4/41 • Number of events 4
|
10.0%
4/40 • Number of events 4
|
|
Blood and lymphatic system disorders
Hyperglycaemia
|
0.00%
0/41
|
2.5%
1/40 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Achilles Tendonitis
|
4.9%
2/41 • Number of events 2
|
10.0%
4/40 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place