The Doses of Systemic Steroid in Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)

The Therapeutic Impact of Various Doses of Systemic Steroid in Acute Exacerbation of Chronic Obstructive Pulmonary Disease

It is well established that steroid use is a benefit in the treatment of chronic obstructive pulmonary disease (COPD) with acute exacerbation (AE). But it is still debated about the regimen and dosage of steroid use. From this retrospective review of medical charts, the researchers investigated the therapeutic impact of various steroid dosages in COPD with AE.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease

Detailed Description

Data collection from medical charts was conducted at Far Eastern Memorial Hospital, a tertiary-care hospital with around 900 beds. Patients who were admitted from January 2008 to December 2008 and diagnosed as having chronic obstructive pulmonary disease with acute exacerbation (code ICD-9: 491.21) were included in this study. The study was approved by the Institutional Review Board of the Far Eastern Memorial Hospital (FEMH:098097-3).

Demographic data, medical histories and medicine prescriptions at outpatient clinics, emergency and inpatient departments were collected. The initial presentations of acute exacerbation and laboratory data were also summarized from the records of the emergency department. The reports of pulmonary function tests within 6 months before or after the exacerbations were included while reviewing the charts. The probability of concomitant pneumonia (pAECOPD) was determined by attending physicians and reviewed by the investigator according to the radiologic findings. If there were incoherent opinions about the probability of pneumonia between the physicians and the investigator, it was determined by another independent pulmonologist. The highest daily doses and total doses of systemic steroids were calculated and recorded as the equivalent doses of prednisolone (1 mg methylprednisolone is equal to 1.25 mg prednisolone; 1 mg hydrocortisone is equal to 0.25 mg prednisolone). The subjects were divided into 3 groups according to the highest daily dose of steroids as follows: patients receiving more than 60 mg/day were designated to the HD group; those receiving less than or equal to 60 mg/day to the LD group; and those who did not receive any steroids during admission to the NIL group. The length of stay (LOS) was defined as the duration from admission to the emergency department to discharge. Hyperglycemia, psychosis, nosocomial infections and active peptic ulcer diseases were regarded as acute side effects of systemic steroids. Hyperglycemia was defined as a new blood sugar level of more than 200 mg/dl in patients without a history of diabetic mellitus, or an increment in diabetes medications. The relapse rate within 30 days was assessed by outpatient follow-up records.

• Study Type: Observational
• Enrollment (Actual): 164

Contacts and Locations

Study Locations

• Taiwan
  • Taipei County
    • Ban-chiao City, Taipei County, Taiwan, 220
      • Far Eastern Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

From January 2008 to December 2008, patients were admitted and diagnosed as having chronic obstructive pulmonary disease with acute exacerbation (code ICD-9: 491.21)

Description

Inclusion Criteria:

• From January 2008 to December 2008, patients were admitted and diagnosed as having chronic obstructive pulmonary disease with acute exacerbation (code ICD-9: 491.21)

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
HD, LD, NIL; HD: the highest daily dose of steroids receiving more than 60 mg/day LD: the highest daily dose of steroids receiving less or equal to 60 mg/day NIL: no steroid use

What is the study measuring?

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
side effects	the side effects of the systemic steroids within groups with different steroid regimens.	2009
30-day relapse rates	the 30-day relapse rates within groups of various steroid doses	2009

Collaborators and Investigators

• Sponsor: Far Eastern Memorial Hospital
• Investigators: Principal Investigator: Ping-huai Wang, MD, Far Eastern Memorial Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: October 5, 2010
• First Submitted That Met QC Criteria: October 6, 2010
• First Posted (Estimate): October 7, 2010

Study Record Updates

• Last Update Posted (Estimate): October 7, 2010
• Last Update Submitted That Met QC Criteria: October 6, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: Chronic obstructive pulmonary disease; systemic steroid
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 098097-3