Treatment in Patients Hospitalized With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

— TripAE  

Official title:

Treatment in Patients Hospitalized With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02219360
• Other study ID #: 2014-K-115
• Status: Not yet recruiting
• Phase: N/A
• First received: July 9, 2014
• Last updated: August 15, 2014
• Start date: August 2014
• Est. completion date: September 2015

Study information

• Verified date: August 2014
• Source: Beijing Chao Yang Hospital
• Contact: Huang Kewu, M.D.
• Phone: 86-10-85231167
• Email: kewuhuang[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: September 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	percentage of use of systemic corticosteroid in patients		8 months after the first enrollment	No
Primary	change of the score of COPD Assesment Test as a measurement of the overall condition of the patient		baseline, 1 month after dischahge, 2 months after discharge	No
Secondary	change of the score of modified Medical British Research Council questionaire as a measurement of the overall condition of the patient		baseline, 1 month after discharge, 2 months after discharge	No