COPD
Conditions
Keywords
Chronic Obstructive Pulmonary Disease, COPD, Chronic bronchitis, emphysema, Corticosteroids
Brief summary
COPD (chronic obstructive pulmonary disease) is a long-lasting lung disease usually caused by long-term smoking. COPD can get worse, making people sick enough to need hospitalization. Corticosteroids are very effective and are almost always used, but nobody knows the right dose. High doses may work better but could cause more side effects than low doses. Typical treatment lengths last at least one week. This study will be comparing two common regimens: either 40mg of corticosteroids daily (low dose), or 80mg of corticosteroids daily (high dose). It is unknown which regimen works better..
Detailed description
The goal of the study is to determine whether a high-dose corticosteroid regimen in patients admitted to the hospital with COPD exacerbations is associated with better clinical outcomes and at acceptable risk of adverse effects compared to a low-dose corticosteroid regimen. Our hypothesis is that high-dose corticosteroids is associated with a decreased rate of treatment failure, shorter length of hospital stay, and improved quality of life with similar risk of adverse effects. The study population includes patients ≥ 40 years-old with a ≥ 10 pack-years smoking history and a diagnosis of COPD, emphysema, or chronic bronchitis who present to the emergency room with increased dyspnea, increased sputum, or increased cough that requires admission to the hospital. We will perform a prospective, randomized, double-blinded study to determine if a high-dose corticosteroid regimen, which is already in use in clinical practice, decreases treatment failure compared to a low-dose corticosteroid regimen that is based on national consensus guidelines.
Interventions
DRUGHigh Dose Corticosteroids
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
i. Patients with a diagnosis of COPD, emphysema, or chronic bronchitis ii. Age ≥ 40 years-old iii. Smoking history ≥ 10 pack-years iv. Presentation to the emergency room with increased dyspnea, increased sputum, or increased cough v. Admission to the hospital
Exclusion criteria
i. Alternative diagnosis for cause of dyspnea, increased sputum or cough ii. Patients who requires intubation at time of recruitment iii. Patients who are unable to give consent iv. Patients who are pregnant or could be pregnant or are currently breast-feeding v. Women of child-bearing age who cannot use methods of contraception as described in the consent, including condoms, female condoms, cervical caps, diaphragms, and intra uterine devices. vi. Patients who were previously entered into the trial and are re-admitted to the hospital with a new COPD exacerbation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Failure | 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay | 30 days | Hospital days from randomization to discharge |
| Quality of Life Score | 30 days | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Effects | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 47 |
| 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 | 42 |
| Total | 89 |
Baseline characteristics
| Characteristic | High Dose Corticosteroids | Total | Low Dose Corticosteroids |
|---|---|---|---|
| Age, Continuous | 65.9 years STANDARD_DEVIATION 10.3 | 65.3 years STANDARD_DEVIATION 12.5 | 64.7 years STANDARD_DEVIATION 11.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 20 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) White | 32 Participants | 64 Participants | 32 Participants |
| Sex: Female, Male Female | 19 Participants | 40 Participants | 21 Participants |
| Sex: Female, Male Male | 23 Participants | 49 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 1 / 40 |
| other Total, other adverse events | 12 / 43 | 10 / 39 |
| serious Total, serious adverse events | 2 / 42 | 2 / 39 |
Outcome results
Primary
Treatment Failure
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.
Time frame: 30 days
Population: Data available for 43 participants the Low Dose Arm and 39 participants in the High Dose Arm
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Dose Corticosteroids | Treatment Failure | 14 Participants |
| High Dose Corticosteroids | Treatment Failure | 10 Participants |
Secondary
Length of Stay
Hospital days from randomization to discharge
Time frame: 30 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low Dose Corticosteroids | Length of Stay | 2 days |
| High Dose Corticosteroids | Length of Stay | 2 days |
Secondary
Quality of Life Score
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.
Time frame: 30 days
Population: Data are missing for 6 in the Low Dose Arm and 5 in the High Dose Arm
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low Dose Corticosteroids | Quality of Life Score | 1.8 score on scale of 0 (best) to 6 (worst) |
| High Dose Corticosteroids | Quality of Life Score | 1.8 score on scale of 0 (best) to 6 (worst) |
Other Pre-specified
Adverse Effects
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.
Time frame: 30 days