The Effect of Reduced Corticosteroid Therapy in Patients With Acute Exacerbation of COPD
Overview
- Phase
- Phase 4
- Intervention
- Prednisolone
- Conditions
- Lung Diseases, Obstructive
- Sponsor
- Chronic Obstructive Pulmonary Disease Trial Network, Denmark
- Enrollment
- 318
- Locations
- 4
- Primary Endpoint
- Days alive and out of hospital within 14 days after recruitment
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study explores whether patients hospitalized with chronic obstructive pulmonary disease (COPD) exacerbation may have fewer days with prednisolone and with the same treatment effect by controlling the treatment by daily measurements of eosinophils.
Detailed Description
The most commonly used treatment for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) is a 5-day treatment with corticosteroids in moderate-high dose. Some patients receive repeated treatments, although it has been shown that corticosteroids only have temporary beneficial effects and no effect in relation to serious incidents or mortality. It has been found that the higher accumulated prednisolone dose disables patients due to serious side effects, including pneumonia, dysregulated diabetes, bone fracture in the context of osteoporosis, mental disorder and adrenal insufficiency etc. However, the extent of the side effects is unknown. Recent research has shown that it is presumably only a small subset of COPD patients who benefit from corticosteroid therapy. This group can be identified by the biomarker "blood-eosinophils" as already measured on most AECOPD patients during hospitalization. This is a randomized, controlled, multi-center, non-Inferiority trial evaluating the effect of eosinophil guided corticosteroid therapy to patients with AECOPD. The aim of the study is to investigate whether the accumulated dose corticosteroid treatment during admissions for AECOPD can be reduced, including the presumed side effects, while (still) remaining the optimal treatment effect.
Investigators
Pradeesh Sivapalan
MD, Ph.d.-student
Chronic Obstructive Pulmonary Disease Trial Network, Denmark
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Blood eosinophil guided prednisolone treatment
Intravenous Solu-Medrol 80 mg, followed by prednisolone tablet 37.5 mg daily (maximum of 5 days in all) if the eosinophil count in the blood ≥ 0.3 x 10E9/L. Eosinophil count in the blood \<0.3 x 10E9/L results in no treatment with prednisolone. If the patient is discharged during the treatment period, given treatment from the last measured eosinophil count the remaining days.
Intervention: Prednisolone
Standard of care
Intravenous Solu-Medrol 80 mg on the first day followed by 37.5 mg of prednisolone tablets (1 x 25 mg plus 1 x 12.5 mg) daily for 5 days
Intervention: Prednisolone
Outcomes
Primary Outcomes
Days alive and out of hospital within 14 days after recruitment
Time Frame: 14 days from recruitment
Secondary Outcomes
- Treatment failure (Recurrence of AECOPD resulting in emergency room visits, hospitalization or need to intensify pharmacological treatment within 30 days)(30 days)
- Change in lung function (ΔFEV1) on day 3, after 1 month and 3 month(90 days)
- Mortality(360 days)
- Cumulative corticosteroid dose at 1 and 3 month follow-up(90 days)
- Changes in PTH and Vitamin D status between hospitalization and 3-month follow-up(90 days)
- Infection requiring antibiotic treatment within 180 days after the index of AECOPD(180 days)
- The period between index AECOPD and the next AECOPD exacerbation(90 days)
- Hyperglycemia during admission(14 days)
- Change in bone marker levels (Serum P1NP, Serum CTX)(90 days)
- New onset or worsening of diabetes mellitus(30 days)
- Increase in body mass index between hospitalization, at 30 days and 3-month follow-up(90 days)
- The impact of COPD (cough, sputum, dysnea, chest tightsenes etc) on health status (COPD Assessment Test) between hospitalization, at 30 days and 3-month follow-up(90 days)
- Changes in level of dyspnea using the Medical Research Council (MRC) Dyspnoea Scale between hospitalization, at 30 days and 3-month follow-up(90 days)
- Osteoporotic fractures(360 days)
- Dyspepsia or ulcer complications (gastrointestinal bleeding)(90 days)