1) Whether a reduction of the dose systemic corticosteroids (SC) therapy in patients with acute exacerbation of COPD(AE-COPD) - compared with AE-COPD patients in the standard treatment- leading to non-inferiority 2)Whether there is a difference in treatment response in AE-COPD patients with eosinophilic airway inflammation compared to AE-COPD patients with non-eosinophilic airway inflammation 3) whether a lower accumulated dose SC may be associated with fewer corticosteroid adverse events
Conditions
Interventions
Trade Name: Prednisolon
Product Name: prednisolon
Pharmaceutical Form: Coated tablet
INN or Proposed INN: PREDNISOLONE
Current Sponsor c
Sponsors
Chronic Obstructive Pulmonary Disease Trial Network (COP:TRIN)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients hospitalized with COPD exacerbation 2) Age = 40 years 3) Spirometry-verified COPD (defined as FEV1 / FVC = 70%) 4) GOLD class C or D 5) Inclusion within 24 hours after admission Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 290
Exclusion criteria
Exclusion criteria: 1) Known with a diagnosis of asthma 2) Life expectancy less than 30 days 3) Serious exacerbation requiring invasive ventilation or admission to ICU 4) Allergy to systemic corticosteroids 5) Severe mental illness, which is not controlled by medication 6) People who are detained under the act on the use of coercion in psychiatry 7) Severe language problems or inability to provide written informed consent 8) Pregnancy and lactation 9) Systemic fungal infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose is to examine whether we can reduce the accumulated corticosteroid therapy to the individual COPD patient with the aim of reducing the number of corticosteroid-related adverse events.; Secondary Objective: Is there a difference in treatment response in AE-COPD patients with eosinophilic airway inflammation and AE-COPD patients with predominantly non-eosinophilic airway inflammation ;Primary end point(s): 1) Days alive and out of hospital within 14 days after recruitment;Timepoint(s) of evaluation of this end point: 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Treatment failure (Recurrence of COPD exacerbation resulting in emergency room visits, hospitalization or need to intensify pharmacological treatment within 30 days) 2) Change in lung function (?FEV1) on day 3, after 1 month and 3 month follow-up 3) Mortality rate 360 days 4) infection requiring antibiotic treatment within 180 days after the index AECOPD exacerbation 5) The period between index AECOPD and the next AECOPD exacerbation a. Readmission with AECOPD or death b. Time to readmission with AECOPD or death 6) Cumulative corticosteroid dose at 1 and 3 months follow-up a. Proportions of patients using corticosteroids during hospitalization (day 1 to day 5) between treatment arms b. Mean total cumulative dose from recruitment to 3-month follow-up 7) Hyperglycemia during admission 8) One or more of the following adverse effects: - Changes in the rate of bone turnover (bone turnover markers): during hospitalization, 1 month and 3 month follow-up - Dyspepsia, change in dyspepsia medication or gastrointestinal bleeding: during hospitalization, 1 month and 3 month follow-up - New onset or worsening of diabetes mellitus : during hospitalization and 1 month follow-up - Increase in body mass index : during hospitalization, 1 month and 3 month follow-up - Change in vitamin D status or PTH function: during hospitalization, 1 month and 3 month follow-up 9) The impact of COPD (cough, sputum, dysnea, chest tighteness) on health status (COPD Assessment Test): during hospitalization, 1 month and 3 month follow-up 10) MRC score: during hospitalization, 1 month and 3 month follow 11) Osteoporotic fractures from hospitalization and 360 d | — |
Countries
Denmark
Outcome results
None listed