Dose of Corticosteroids in COPD

COPD Clinical Trial

— DOSE  

Official title:

Determining Optimal Dose of Corticosteroids in COPD Exacerbations: A Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01742338
• Other study ID #: 0220120019
• Status: Terminated
• Phase: Phase 4
• Start date: May 3, 2012
• Est. completion date: March 15, 2020

Study information

• Verified date: March 2024
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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..

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 89
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD

Intervention

Drug:
• Low Dose Corticosteroids

• High Dose Corticosteroids

Locations

Country	Name	City	State
United States	Robert Wood Johnson University Hospital	New Brunswick	New Jersey
United States	University Medical Center at Princeton	Plainsboro	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	30 days
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.	30 days
Secondary	Length of Stay	Hospital days from randomization to discharge	30 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.	30 days