Trial Outcomes & Findings for Dose of Corticosteroids in COPD (NCT NCT01742338)

Last Updated: 2024-04-10

Results Overview

Composite outcome of treatment failure defined as death, intubation, re-admission for COPD exacerbation, or intensification of therapy (increased steroid use, change of antibiotic therapy) within a 30-day follow-up period.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

89 participants

Primary outcome timeframe

30 days

Results posted on

2024-04-10

Participant Flow

Participant milestones

Participant milestones
Measure	Low Dose Corticosteroids 10 mg IV q8hrs x 3 days\, then prednisone 40 mg PO daily x 4 days, then prednisone 30 mg daily x 1 day, then prednisone 20 mg daily x 1 day, then prednisone 10 mg daily x 1 day, then stop. \If patient unable to receive IV medications, will give prednisone 20 mg PO bid for the first 3 days. Low Dose Corticosteroids	High Dose Corticosteroids Methylprednisolone 40 mg IV q8hrs x 3 days\, then prednisone 80 mg PO daily x 4 days, then prednisone 60 mg daily x 1 day, then prednisone 40 mg daily x 1 day, then prednisone 20 mg daily x 1 day, then stop. \If patient unable to receive IV medications, will give prednisone 40 mg PO bid for the first 3 days. High Dose Corticosteroids
Overall Study STARTED	47	42
Overall Study COMPLETED	43	39
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dose of Corticosteroids in COPD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Dose Corticosteroids n=47 Participants 10 mg IV q8hrs x 3 days\, then prednisone 40 mg PO daily x 4 days, then prednisone 30 mg daily x 1 day, then prednisone 20 mg daily x 1 day, then prednisone 10 mg daily x 1 day, then stop. \If patient unable to receive IV medications, will give prednisone 20 mg PO bid for the first 3 days. Low Dose Corticosteroids	High Dose Corticosteroids n=42 Participants Methylprednisolone 40 mg IV q8hrs x 3 days\, then prednisone 80 mg PO daily x 4 days, then prednisone 60 mg daily x 1 day, then prednisone 40 mg daily x 1 day, then prednisone 20 mg daily x 1 day, then stop. \If patient unable to receive IV medications, will give prednisone 40 mg PO bid for the first 3 days. High Dose Corticosteroids	Total n=89 Participants Total of all reporting groups
Age, Continuous	64.7 years STANDARD_DEVIATION 11.3 • n=5 Participants	65.9 years STANDARD_DEVIATION 10.3 • n=7 Participants	65.3 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	19 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	23 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	7 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	32 Participants n=7 Participants	64 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Data available for 43 participants the Low Dose Arm and 39 participants in the High Dose Arm

Outcome measures

Outcome measures
Measure	Low Dose Corticosteroids n=43 Participants 10 mg IV q8hrs x 3 days\, then prednisone 40 mg PO daily x 4 days, then prednisone 30 mg daily x 1 day, then prednisone 20 mg daily x 1 day, then prednisone 10 mg daily x 1 day, then stop. \If patient unable to receive IV medications, will give prednisone 20 mg PO bid for the first 3 days. Low Dose Corticosteroids	High Dose Corticosteroids n=39 Participants Methylprednisolone 40 mg IV q8hrs x 3 days\, then prednisone 80 mg PO daily x 4 days, then prednisone 60 mg daily x 1 day, then prednisone 40 mg daily x 1 day, then prednisone 20 mg daily x 1 day, then stop. \If patient unable to receive IV medications, will give prednisone 40 mg PO bid for the first 3 days. High Dose Corticosteroids
Treatment Failure	14 Participants	10 Participants

SECONDARY outcome

Timeframe: 30 days

Hospital days from randomization to discharge

Outcome measures

Outcome measures
Measure	Low Dose Corticosteroids n=47 Participants 10 mg IV q8hrs x 3 days\, then prednisone 40 mg PO daily x 4 days, then prednisone 30 mg daily x 1 day, then prednisone 20 mg daily x 1 day, then prednisone 10 mg daily x 1 day, then stop. \If patient unable to receive IV medications, will give prednisone 20 mg PO bid for the first 3 days. Low Dose Corticosteroids	High Dose Corticosteroids n=42 Participants Methylprednisolone 40 mg IV q8hrs x 3 days\, then prednisone 80 mg PO daily x 4 days, then prednisone 60 mg daily x 1 day, then prednisone 40 mg daily x 1 day, then prednisone 20 mg daily x 1 day, then stop. \If patient unable to receive IV medications, will give prednisone 40 mg PO bid for the first 3 days. High Dose Corticosteroids
Length of Stay	2 days Interval 0.0 to 3.0	2 days Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: 30 days

Population: Data are missing for 6 in the Low Dose Arm and 5 in the High Dose Arm

Quality of life measured by Clinical COPD Questionnaire. The Clinical COPD Questionnaire consists of 10 questions about the severity of COPD symptoms and limitation of activities over the prior week.

Outcome measures

Outcome measures
Measure	Low Dose Corticosteroids n=41 Participants 10 mg IV q8hrs x 3 days\, then prednisone 40 mg PO daily x 4 days, then prednisone 30 mg daily x 1 day, then prednisone 20 mg daily x 1 day, then prednisone 10 mg daily x 1 day, then stop. \If patient unable to receive IV medications, will give prednisone 20 mg PO bid for the first 3 days. Low Dose Corticosteroids	High Dose Corticosteroids n=37 Participants Methylprednisolone 40 mg IV q8hrs x 3 days\, then prednisone 80 mg PO daily x 4 days, then prednisone 60 mg daily x 1 day, then prednisone 40 mg daily x 1 day, then prednisone 20 mg daily x 1 day, then stop. \If patient unable to receive IV medications, will give prednisone 40 mg PO bid for the first 3 days. High Dose Corticosteroids
Quality of Life Score	1.8 score on scale of 0 (best) to 6 (worst) Interval 0.8 to 2.8	1.8 score on scale of 0 (best) to 6 (worst) Interval 1.2 to 2.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

Composite outcome of short-term adverse effects. Defined as hyperglycemia, hypertension, adrenal suppression, psychiatric disturbance, infection, and gastrointestinal bleed that require a consultation, an invasive procedure, or initiation of a specific therapy.

Outcome measures

Outcome data not reported

Adverse Events

Low Dose Corticosteroids

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

High Dose Corticosteroids

Serious events: 2 serious events

Other events: 10 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Low Dose Corticosteroids n=43 participants at risk；n=42 participants at risk 10 mg IV q8hrs x 3 days\, then prednisone 40 mg PO daily x 4 days, then prednisone 30 mg daily x 1 day, then prednisone 20 mg daily x 1 day, then prednisone 10 mg daily x 1 day, then stop. \If patient unable to receive IV medications, will give prednisone 20 mg PO bid for the first 3 days. Low Dose Corticosteroids	High Dose Corticosteroids n=39 participants at risk Methylprednisolone 40 mg IV q8hrs x 3 days\, then prednisone 80 mg PO daily x 4 days, then prednisone 60 mg daily x 1 day, then prednisone 40 mg daily x 1 day, then prednisone 20 mg daily x 1 day, then stop. \If patient unable to receive IV medications, will give prednisone 40 mg PO bid for the first 3 days. High Dose Corticosteroids
Respiratory, thoracic and mediastinal disorders COPD Exacerbation	4.8% 2/42 • Number of events 2 • 30 Days Data are missing for 1) Death - 5 in the Low Dose Arm; 2 in the High Dose Arm 2) COPD Exacerbation - 5 in the Low Dose Arm; 3 in the High Dose Arm 3) Theraputic Intensification - 4 in the Low Dose Arm; 3 in the High Dose Arm	5.1% 2/39 • Number of events 2 • 30 Days Data are missing for 1) Death - 5 in the Low Dose Arm; 2 in the High Dose Arm 2) COPD Exacerbation - 5 in the Low Dose Arm; 3 in the High Dose Arm 3) Theraputic Intensification - 4 in the Low Dose Arm; 3 in the High Dose Arm

Other adverse events

Other adverse events
Measure	Low Dose Corticosteroids n=43 participants at risk；n=42 participants at risk 10 mg IV q8hrs x 3 days\, then prednisone 40 mg PO daily x 4 days, then prednisone 30 mg daily x 1 day, then prednisone 20 mg daily x 1 day, then prednisone 10 mg daily x 1 day, then stop. \If patient unable to receive IV medications, will give prednisone 20 mg PO bid for the first 3 days. Low Dose Corticosteroids	High Dose Corticosteroids n=39 participants at risk Methylprednisolone 40 mg IV q8hrs x 3 days\, then prednisone 80 mg PO daily x 4 days, then prednisone 60 mg daily x 1 day, then prednisone 40 mg daily x 1 day, then prednisone 20 mg daily x 1 day, then stop. \If patient unable to receive IV medications, will give prednisone 40 mg PO bid for the first 3 days. High Dose Corticosteroids
Respiratory, thoracic and mediastinal disorders Theraputic Instensification	27.9% 12/43 • Number of events 12 • 30 Days Data are missing for 1) Death - 5 in the Low Dose Arm; 2 in the High Dose Arm 2) COPD Exacerbation - 5 in the Low Dose Arm; 3 in the High Dose Arm 3) Theraputic Intensification - 4 in the Low Dose Arm; 3 in the High Dose Arm	25.6% 10/39 • Number of events 10 • 30 Days Data are missing for 1) Death - 5 in the Low Dose Arm; 2 in the High Dose Arm 2) COPD Exacerbation - 5 in the Low Dose Arm; 3 in the High Dose Arm 3) Theraputic Intensification - 4 in the Low Dose Arm; 3 in the High Dose Arm

Additional Information

Dr. Jeffrey L. Carson

Rutgers Robert Wood Johnson Medical School

Phone: 732-235-7122

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place