Personalized Variable Versus Fixed Dose Glucocorticoid Therapy in AECOPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Personalized Variable Versus Fixed Dose Corticosteroids Therapy in Hospitalized Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02147015
• Other study ID #: VIP
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: April 2018

Study information

• Verified date: October 2020
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: April 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Glucocorticoids

• Antibiotics

• Inhaled corticosteroid (ICS)

• Long-Acting Muscarinic Antagonists(LAMA)

• Short-acting beta2-agonist (SABA)

Other:
• Physical treatments

Drug:
• long-acting beta2-agonist (LABA)

Locations

Country	Name	City	State
China	Daping Hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

Davies L, Angus RM, Calverley PM. Oral corticosteroids in patients admitted to hospital with exacerbations of chronic obstructive pulmonary disease: a prospective randomised controlled trial. Lancet. 1999 Aug 7;354(9177):456-60. — View Citation

Leuppi JD, Schuetz P, Bingisser R, Bodmer M, Briel M, Drescher T, Duerring U, Henzen C, Leibbrandt Y, Maier S, Miedinger D, Müller B, Scherr A, Schindler C, Stoeckli R, Viatte S, von Garnier C, Tamm M, Rutishauser J. Short-term vs conventional glucocorticoid therapy in acute exacerbations of chronic obstructive pulmonary disease: the REDUCE randomized clinical trial. JAMA. 2013 Jun 5;309(21):2223-31. doi: 10.1001/jama.2013.5023. — View Citation

Lindenauer PK, Pekow PS, Lahti MC, Lee Y, Benjamin EM, Rothberg MB. Association of corticosteroid dose and route of administration with risk of treatment failure in acute exacerbation of chronic obstructive pulmonary disease. JAMA. 2010 Jun 16;303(23):2359-67. doi: 10.1001/jama.2010.796. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospital costs		up to 1 month
Primary	Treatment failure	death from any cause; admission to the intensive care unit; readmission to the hospital because of COPD; the necessity to intensify pharmacologic treatment during in-hospital (due to persistence of dyspnoea, bronchospasm, or worsening of other respiratory symptoms)	6 months
Secondary	length of hospital stay		1 month