Clinical trial NCT02147015: Personalized Variable Versus Fixed Dose Glucocorticoid Therapy in AECOPD
Official title: Personalized Variable Versus Fixed Dose Corticosteroids Therapy in Hospitalized Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Acute Exacerbations
Corticosteroids
Chronic Obstructive Pulmonary Disease
Doses
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2014-05-26
Enrollment: 248
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment failure
timeFrame: 6 months
Secondary outcomes:
measure: length of hospital stay
timeFrame: 1 month
Other outcomes:
measure: Hospital costs
timeFrame: up to 1 month
Locations:
city: Chongqing
country: China
facility: Daping Hospital
state: Chongqing
Study officials:
affiliation: Daping Hospital, Third Military Medical University
name: Guoqiang Cao, Medical Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/s0140-6736(98)11326-0.
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.
citation: Leuppi JD, Schuetz P, Bingisser R, Bodmer M, Briel M, Drescher T, Duerring U, Henzen C, Leibbrandt Y, Maier S, Miedinger D, Muller 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.
citation: Li L, Zhao N, Ma X, Sun F, He B, Qin Z, Wu K, Wang X, Zhao Q, Zhang S, Nie N, Luo D, Sun B, Shen Y, He Y, Wen F, Zheng J, Jones P, Cao G. Personalized Variable vs Fixed-Dose Systemic Corticosteroid Therapy in Hospitalized Patients With Acute Exacerbations of COPD: A Prospective, Multicenter, Randomized, Open-Label Clinical Trial. Chest. 2021 Nov;160(5):1660-1669. doi: 10.1016/j.chest.2021.05.024. Epub 2021 May 21.