NCT02051166

Brief Summary

The purpose of this study is observe clinical practice including glucocorticoids treatment in AECOPD in China.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,095

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2014

Shorter than P25 for all trials

Geographic Reach
1 country

13 active sites

Status
completed

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

January 24, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

June 15, 2016

Status Verified

June 1, 2016

Enrollment Period

6 months

First QC Date

January 24, 2014

Last Update Submit

June 14, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of glucocorticoids treatment for AECOPD

    day 1 to up to 30 days (Hospital discharge)

Secondary Outcomes (9)

  • Percentage of oral /intravenous/ inhaled steroid therapy in patients treated with glucocorticoids, mean dosage, regimen and treatment duration via different administration route in hospital

    day 1 to up to 30 days (Hospital discharge)

  • Percentage of antibiotics treatment for AECOPD by clinicians during the hospitalization.

    day 1 to up to 30 days (Hospital discharge)

  • Mortality caused by AECOPD and recorded as primary cause of death by clinicians

    day 1 to up to 30 days (Hospital discharge)

  • Percentage of antibiotics treatment via different administration route for AECOPD, mean treatment duration via different administration route in hospital

    day 1 to up to 30 days (Hospital discharge)

  • Endotracheal intubation rate in treatment of AECOPD

    day 1 to up to 30 days (Hospital discharge)

  • +4 more secondary outcomes

Other Outcomes (5)

  • Demographic data

    day 1

  • Year of COPD diagnosis

    day 1

  • Any other significant medical condition or co-morbidities

    day 1

  • +2 more other outcomes

Eligibility Criteria

Age40 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patient population will be ≥40 years of age, received hospitalization due to AECOPD since Sep, 2013. The patients should be diagnosed by GOLD 2013 as COPD at least 3 months before AECOPD based on treating physician judgment.

You may qualify if:

  • ≥40 years old
  • Hospitalization treatment due to AECOPD since Sep, 2013
  • Diagnosed by GOLD 2013 as COPD at least 3 months before AECOPD based on treating physician's judgment
  • Provided informed consent or informed consent waiver

You may not qualify if:

  • Participation in any interventional clinical study within 3 months before being recruited in the study.
  • Ongoing AECOPD during recruitment timeline
  • The patients whose symptoms haven't recovered and then discharge by themselves
  • The primary diagnosis of hospitalization is not AECOPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Research Site

Hefei, Anhui, China

Location

Research Site

Beijing, Beijing Municipality, China

Location

Research Site

Langfang, Hebei, China

Location

Research Site

Baotou, Inner Mongolia, China

Location

Research Site

Hohhot, Inner Mongolia, China

Location

Research Site

Yinchuan, Ningxia, China

Location

Research Site

Shanghai, Shanghai Municipality, China

Location

Research Site

Taiyuan, Shanxi, China

Location

Research Site

Xi’an, Shanxi, China

Location

Research Site

Beijing, China

Location

Research Site

Guangzhou, China

Location

Research Site

Shanghai, China

Location

Research Site

Tianjin, China

Location

Related Publications (1)

  • Zheng JP, Zhang J, Ma LJ, Chen P, Huang M, Ou XM, Zhao ZW, Jiang SJ, Cao J, Yao W. Clinical Outcomes Of Using Nebulized Budesonide As The Initial Treatment For Acute Exacerbations Of Chronic Obstructive Pulmonary Disease: A Post-Hoc Analysis. Int J Chron Obstruct Pulmon Dis. 2019 Nov 29;14:2725-2731. doi: 10.2147/COPD.S196615. eCollection 2019.

Related Links

Study Officials

  • Wanzhen Yao, Ph.D

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2014

First Posted

January 31, 2014

Study Start

February 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

June 15, 2016

Record last verified: 2016-06

Locations