Clinical trial NCT02219360: Treatment in Patients Hospitalized With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Official title: Treatment in Patients Hospitalized With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: acute
exacerbation
chronic obstructive pulmonary disease
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2014-08-18
Enrollment: 400
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized with acute exacerbation of chronic obstructive pulmonary disease from 1st July, 2014 from Beijing Chao Yang Hospital

Brief summary: Chronic obstructive pulmonary disease has become a serious global health care and public health problems due to its high prevalence, high morbidity and heavy economic burden. Acute exacerbation of chronic obstructive pulmonary disease is one of the most important causes of death in patients with COPD. Systemic corticosteroids therapy is recommended in COPD exacerbations. In clinical practice for the treatment of acute exacerbation of COPD， antibiotic application is still controversial. Evidence from current guideline is based on strict criteria from randomized controlled trials, thus the given condition is simplified. Patients meet the criteria account for the minority in the real world. Therefore, it is still not clear whether most patients benefit from the recommended treatment. In our design, hospitalized patients with acute exacerbation of COPD will be enrolled, with their treatment, arterial hypoxemia, recovery time and length of hospitalization being observed. The main purpose is to evaluate the benefit effect of current recommended treatment of acute exacerbation of COPD in the real world.

Detailed description: Chronic obstructive pulmonary disease has become a serious global health care and public health problems due to its high prevalence, high morbidity and heavy economic burden. Acute exacerbation of COPD is one of the most important causes of death in patients with COPD. The global strategy for the diagnosis, management, and prevention of COPD recommends systemic corticosteroids therapy in COPD exacerbations as it can shorten recovery time, reduce treatment failure, improve lung function and arterial hypoxemia. In clinical practice for the treatment of acute exacerbation of COPD， antibiotic application is still controversial. Evidence from current guideline is based on strict criteria from randomized controlled trials, thus the given condition is simplified. Patients meet the criteria account for the minority in the real world. Therefore, it is still not clear whether most patients benefit from the recommended treatment. In our design, hospitalized patients with acute exacerbation of COPD will be enrolled, with their treatment, arterial hypoxemia, recovery time and length of hospitalization being observed. The main purpose is to evaluate the benefit effect of current recommended treatment of acute exacerbation of COPD in the real world.

Eligibility criteria: Inclusion Criteria:

* Hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease
* Age≥ 40years old

Exclusion Criteria:

* The first diagnosis which caused hospitalization is not acute exacerbation of chronic obstructive pulmonary disease
* Chest radiography shows congestive heart failure
* Chest CT shows lung cancer, active pulmonary tuberculosis, pulmonary thromboembolism or interstitial lung diseases
* Serious cardiac failure, renal insufficiency or hepatic dysfunction

Primary outcomes:
measure: change of the score of COPD Assesment Test as a measurement of the overall condition of the patient
timeFrame: baseline, 1 month after dischahge, 2 months after discharge
Secondary outcomes:
measure: change of the score of modified Medical British Research Council questionaire as a measurement of the overall condition of the patient
timeFrame: baseline, 1 month after discharge, 2 months after discharge
Other outcomes:
measure: percentage of use of systemic corticosteroid in patients
timeFrame: 8 months after the first enrollment
Locations:
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Wang Ying, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Chao Yang Hospital
name: Huang Kewu, M.D.
role: STUDY_CHAIR
References: