- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02219360
Treatment in Patients Hospitalized With Acute Exacerbation of Chronic Obstructive Pulmonary Disease (TripAE)
August 15, 2014 updated by: Wang Ying, Beijing Chao Yang Hospital
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.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Huang Kewu, M.D.
- Phone Number: 86-10-85231167
- Email: kewuhuang@126.com
Study Contact Backup
- Name: Wang Ying, Master
- Phone Number: 86-0-13426121753
- Email: kokosalaki1020@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change of the score of COPD Assesment Test as a measurement of the overall condition of the patient
Time Frame: baseline, 1 month after dischahge, 2 months after discharge
|
baseline, 1 month after dischahge, 2 months after discharge
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change of the score of modified Medical British Research Council questionaire as a measurement of the overall condition of the patient
Time Frame: baseline, 1 month after discharge, 2 months after discharge
|
baseline, 1 month after discharge, 2 months after discharge
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
percentage of use of systemic corticosteroid in patients
Time Frame: 8 months after the first enrollment
|
8 months after the first enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wang Ying, Master, Beijing Chao Yang Hospital
- Study Chair: Huang Kewu, M.D., Beijing Chao Yang Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Anticipated)
June 1, 2015
Study Completion (Anticipated)
September 1, 2015
Study Registration Dates
First Submitted
July 9, 2014
First Submitted That Met QC Criteria
August 15, 2014
First Posted (Estimate)
August 18, 2014
Study Record Updates
Last Update Posted (Estimate)
August 18, 2014
Last Update Submitted That Met QC Criteria
August 15, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-K-115
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Obstructive Pulmonary Disease
-
Spire, Inc.ResMedCompletedSevere Chronic Obstructive Pulmonary Disease | Moderate Chronic Obstructive Pulmonary DiseaseUnited States
-
Karaganda Medical UniversityCompletedChronic Obstructive Pulmonary Disease | Chronic Obstructive Pulmonary Disease Moderate | Chronic Obstructive Pulmonary Disease SevereKazakhstan
-
Randall DebattistaUniversity of Malta, Faculty of Health SciencesNot yet recruitingChronic Obstructive Pulmonary Disease Moderate | Acute Exacerbation of COPD | Chronic Obstructive Pulmonary Disease Severe
-
Cukurova UniversityCompletedAnesthesia | Chronic Obstructive Pulmonary Disease Moderate | Lungcancer | Chronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease MildTurkey
-
National Taipei University of Nursing and Health...TerminatedChronic Pulmonary Disease | Chronic Obstructive Pulmonary Disease Exacerbation | Chronic Obstructive Pulmonary Disease With ExacerbationTaiwan
-
Taipei Medical UniversityUnknownChronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease End StageTaiwan
-
Mylan Inc.Theravance BiopharmaCompletedChronic Obstructive Pulmonary Disease (COPD)United States
-
University Hospital, GhentGlaxoSmithKline; University GhentCompletedChronic Obstructive Pulmonary Disease (COPD)Belgium
-
Optimum Patient CareRespiratory Effectiveness Group; Boehringer Ingelheim Pharmaceutical Company... and other collaboratorsUnknownChronic Obstructive Pulmonary Disease (13645005)United States
-
Poitiers University HospitalCompletedBroncho Chronic Obstructive Pulmonary DiseaseFrance