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Corticosteroid Reduction in COPD (Cortico-cop)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02857842
Recruitment Status : Completed
First Posted : August 5, 2016
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Pradeesh Sivapalan, Chronic Obstructive Pulmonary Disease Trial Network, Denmark

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.

Condition or disease Intervention/treatment Phase
Lung Diseases, Obstructive Blood Eosinophil Count Glucocorticoids COPD Pulmonary Disease, Chronic Obstructive Drug: Prednisolone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 318 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Reduced Corticosteroid Therapy in Patients With Acute Exacerbation of COPD
Study Start Date : August 2016
Actual Primary Completion Date : September 2018
Actual Study Completion Date : January 2019


Arm Intervention/treatment
Experimental: 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.
Drug: Prednisolone
Active Comparator: 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
Drug: Prednisolone



Primary Outcome Measures :
  1. Days alive and out of hospital within 14 days after recruitment [ Time Frame: 14 days from recruitment ]

Secondary Outcome Measures :
  1. Treatment failure (Recurrence of AECOPD resulting in emergency room visits, hospitalization or need to intensify pharmacological treatment within 30 days) [ Time Frame: 30 days ]
  2. Change in lung function (ΔFEV1) on day 3, after 1 month and 3 month [ Time Frame: 90 days ]
  3. Mortality [ Time Frame: 360 days ]
  4. Infection requiring antibiotic treatment within 180 days after the index of AECOPD [ Time Frame: 180 days ]
  5. The period between index AECOPD and the next AECOPD exacerbation [ Time Frame: 90 days ]
    1. Readmission with AECOPD or death
    2. Time to readmission with AECOPD or death

  6. Cumulative corticosteroid dose at 1 and 3 month follow-up [ Time Frame: 90 days ]
    1. Proportions of patients using corticosteroids during hospitalization (day 1 to day 5) between treatment arms
    2. Mean total cumulative dose from recruitment to 3-month follow-up

  7. Hyperglycemia during admission [ Time Frame: 14 days ]
  8. Changes in PTH and Vitamin D status between hospitalization and 3-month follow-up [ Time Frame: 90 days ]
  9. Change in bone marker levels (Serum P1NP, Serum CTX) [ Time Frame: 90 days ]
  10. Dyspepsia or ulcer complications (gastrointestinal bleeding) [ Time Frame: 90 days ]
  11. New onset or worsening of diabetes mellitus [ Time Frame: 30 days ]
  12. Increase in body mass index between hospitalization, at 30 days and 3-month follow-up [ Time Frame: 90 days ]
  13. 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 ]
  14. 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 ]
  15. Osteoporotic fractures [ Time Frame: 360 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02857842


Locations
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Denmark
Bispebjerg University Hospital
Copenhagen, Denmark
Hvidovre University Hospital
Copenhagen, Denmark
North Zealand Hospital
Copenhagen, Denmark
Gentofte University Hospital
Hellerup, Denmark, 2900
Sponsors and Collaborators
Chronic Obstructive Pulmonary Disease Trial Network, Denmark

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pradeesh Sivapalan, MD, Ph.d.-student, Chronic Obstructive Pulmonary Disease Trial Network, Denmark
ClinicalTrials.gov Identifier: NCT02857842    
Other Study ID Numbers: Protocol_CORTICO-COP_PSJUJ
First Posted: August 5, 2016    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents