Personalized Variable Versus Fixed Dose Glucocorticoid Therapy in AECOPD

Army Medical University of People's Liberation Army

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Inhaled corticosteroid (ICS); Drug: Long-Acting Muscarinic Antagonists(LAMA); Drug: long-acting beta2-agonist (LABA); Drug: Antibiotics; Drug: Short-acting beta2-agonist (SABA); Drug: Glucocorticoids; Other: Physical treatments

Study type: Interventional

Funder types: Other

Identifiers

NCT02147015

VIP

Details and patient eligibility

About

The hypothesis is that in acute exacerbated Chronic Obstructive Pulmonary Disease (AECOPD), personalized variable dose glucocorticoid treatment will result in superior clinical outcome when compared to fixed dose therapy.

Full description

Treatment with glucocorticoid for acute exacerbations of COPD results in the improvement of clinical outcomes. However, the optimal doses of glucocorticoid for each individual patient has not been determined. According to GOLD Report 2014, a dose of 40 mg prednisone per day for 5 days is recommended (Evidence B), although there are insufficient data to provide firm conclusions concerning the optimal duration of corticosteroid therapy of acute exacerbations of COPD. The purpose of the current study is to compare clinical outcomes of personalized or fixed dose of glucocorticoid in patients with acute exacerbations of COPD.

Enrollment: 248 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Exacerbation of COPD as defined by the presence of at least 2 of the following: change in baseline dyspnea, cough, or sputum quantity or purulence.

Exclusion criteria

• Signs of severe exacerbation (arterial pH < 7.26 or PaCO2 > 9.3 kPa)
• History of asthma
• Significant or unstable co-morbidity
• Participated in another study 4 weeks before admission
• Previously randomized to this study
• Known hypersensitivity to prednisolone
• Inability to give written informed consent
• Radiological diagnosis of pneumonia
• Estimated survival of less than 6 months due to severe comorbidity
• Use of glucocorticoid within 1 month before admission

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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248 participants in 2 patient groups

Personalized variable dose of glucocorticoids arm

Experimental group

Description:

Use of personalized variable dose of glucocorticoids according to a rating scale starting from the first day of hospitalization for 5 days, together with other necessary treatments, including antibiotics, Inhaled corticosteroid (ICS), long-acting beta2-agonist (LABA), Long-Acting Muscarinic Antagonists(LAMA), short-acting beta2-agonist (SABA), and other physical treatments.

Treatment:

Drug: Inhaled corticosteroid (ICS)

Drug: long-acting beta2-agonist (LABA)

Drug: Short-acting beta2-agonist (SABA)

Drug: Antibiotics

Drug: Glucocorticoids

Other: Physical treatments

Drug: Long-Acting Muscarinic Antagonists(LAMA)

Fixed dose of glucocorticoids arm

Other group

Description:

Use of fixed term of glucocorticoids (40mg) starting from the first day of hospitalization for 5 days, together with other necessary treatments, including antibiotics, ICS, LABA, LAMA, SABA, and other physical treatments.

Treatment:

Drug: Inhaled corticosteroid (ICS)

Drug: long-acting beta2-agonist (LABA)

Drug: Short-acting beta2-agonist (SABA)

Drug: Antibiotics

Drug: Glucocorticoids

Other: Physical treatments

Drug: Long-Acting Muscarinic Antagonists(LAMA)