NCT02219360

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2014

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2014

Completed
23 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 18, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

August 18, 2014

Status Verified

August 1, 2014

Enrollment Period

10 months

First QC Date

July 9, 2014

Last Update Submit

August 15, 2014

Conditions

Keywords

acuteexacerbationchronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Other Outcomes (1)

  • percentage of use of systemic corticosteroid in patients

    8 months after the first enrollment

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized with acute exacerbation of chronic obstructive pulmonary disease from 1st July, 2014 from Beijing Chao Yang Hospital

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

25-(OH)-VD3 and glycated albumin will be tested

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Wang Ying, Master

    Beijing Chao Yang Hospital

    PRINCIPAL INVESTIGATOR
  • Huang Kewu, M.D.

    Beijing Chao Yang Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

July 9, 2014

First Posted

August 18, 2014

Study Start

August 1, 2014

Primary Completion

June 1, 2015

Study Completion

September 1, 2015

Last Updated

August 18, 2014

Record last verified: 2014-08