Comparing Hydrocortisone and Prednisolone for Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)

NCT ID: NCT06892210

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-11-01

Brief Summary

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The goal of this cluster randomized controlled trial is to determine the optimal treatment for Acute Exacerbation of Chronic Obstructive Pulmonary Disease. The study compares the effects and side effects of hydrocortisone and prednisolone in patients above 40 years old diagnosed with chronic obstructive pulmonary disease with acute exacerbation. The main question is whether there is a difference in readmission for COPD excerbation or all cause mortality within thirty days.

Participants will randomized to receive treatment with either hydrocortisone or prednisolone.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study is a cluster randomized controlled trial. It consists of two arms, in which patients will be randomized to receive treatment with either Hydrocortisone or Methylprednisolone.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment with Hydrocortisone.

This arm will recieve a dose of 200 mg of Hydrocortisone intravenously once daily for five days.

Group Type ACTIVE_COMPARATOR

Hydrocortisone

Intervention Type DRUG

ATC-code: H02AB09. Can be changed to 50 mg x 4 daily orally if appropriate.

Treatment with Methylprednisolone

This arm will recieve a dose of 40 mg of Methylprednisolone intravenously once daily for five days.

Group Type ACTIVE_COMPARATOR

Methylprednisolone (drug)

Intervention Type DRUG

ATC code: H02AB06. Can be changed to Prednisolone 50 mg orally.

Interventions

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Methylprednisolone (drug)

ATC code: H02AB06. Can be changed to Prednisolone 50 mg orally.

Intervention Type DRUG

Hydrocortisone

ATC-code: H02AB09. Can be changed to 50 mg x 4 daily orally if appropriate.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age ≥40 years
* Chronic obstructive pulmonary disease with acute exacerbation, unspecified: ICDJ44

Exclusion Criteria

* All diagnoses that would merit treatment with a specific corticosteroid
* Pregnant or breastfeeding women
* Active tuberculosis or invasive fungal infection
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Copenhagen Respiratory Research

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jens-Ulrik Stæhr Jensen, MD, PHD

Role: STUDY_DIRECTOR

COP:RESP

Central Contacts

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Jens-Ulrik Stæhr Jensen, MD, PHD

Role: CONTACT

38673057 ext. +45

Pradeesh Sivapalan, MD, PHD

Role: CONTACT

29880601 ext. +45

Other Identifiers

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MineraloCOP

Identifier Type: -

Identifier Source: org_study_id

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