NCT Number: NCT02857842
Corticosteroid Reduction in COPD
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.
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Notify MeKey information
Conditions
Age range
40 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Bispebjerg University Hospital, Copenhagen, Denmark
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients hospitalized with AECOPD
- Age ≥ 40 years
- Spirometry-verified COPD (defined as FEV1 / FVC ≤ 70%)
- Chronic Obstructive Lung Disease (GOLD) class C or D
- Inclusion within 24 hours after admission
Exclusion criteria
- Known with a diagnosis of asthma
- Life expectancy less than 30 days
- Serious exacerbation requiring invasive ventilation or admission to ICU
- Allergy to systemic corticosteroids
- Severe mental illness, which is not controlled by medication
- People who are detained under the act on the use of coercion in psychiatry
- Severe language problems or inability to provide written informed consent
- Pregnancy and lactation
- Systemic fungal infections
Treatment and study plan
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)
Time frame: 30 days
-
Change in lung function (ΔFEV1) on day 3, after 1 month and 3 month
Time frame: 90 days
-
Mortality
Time frame: 360 days
-
Infection requiring antibiotic treatment within 180 days after the index of AECOPD
Time frame: 180 days
-
The period between index AECOPD and the next AECOPD exacerbation
Time frame: 90 days
- Readmission with AECOPD or death
- Time to readmission with AECOPD or death
-
Cumulative corticosteroid dose at 1 and 3 month follow-up
Time frame: 90 days
- Proportions of patients using corticosteroids during hospitalization (day 1 to day 5) between treatment arms
- Mean total cumulative dose from recruitment to 3-month follow-up
-
Hyperglycemia during admission
Time frame: 14 days
-
Changes in PTH and Vitamin D status between hospitalization and 3-month follow-up
Time frame: 90 days
-
Change in bone marker levels (Serum P1NP, Serum CTX)
Time frame: 90 days
-
Dyspepsia or ulcer complications (gastrointestinal bleeding)
Time frame: 90 days
-
New onset or worsening of diabetes mellitus
Time frame: 30 days
-
Increase in body mass index between hospitalization, at 30 days and 3-month follow-up
Time frame: 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
Time frame: 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
Time frame: 90 days
-
Osteoporotic fractures
Time frame: 360 days
Sponsors and collaborators
Lead sponsor
Chronic Obstructive Pulmonary Disease Trial Network, Denmark
Other
Registry information
Official study title
The Effect of Reduced Corticosteroid Therapy in Patients With Acute Exacerbation of COPD
Acronym: Cortico-cop
Important dates
- Study start
- 2016
- Primary completion
- 2018
- Study completion
- 2019
- First posted
- Aug 5, 2016
- Registry last updated
- Feb 8, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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