NCT03359122

Brief Summary

The aim of this study is to examine the association of COPD maintenance inhalation medication (Inhaled Corticosteroid or ICS) adherence with COPD exacerbation healthcare resource utilization among COPD patients with exacerbation history.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10,067

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

November 8, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 2, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

June 7, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2018

Completed
Last Updated

July 30, 2019

Status Verified

July 1, 2019

Enrollment Period

2 months

First QC Date

November 8, 2017

Last Update Submit

July 29, 2019

Conditions

Outcome Measures

Primary Outcomes (6)

  • Indicators of COPD control

    Number of exacerbations

    2015.01-2016.12

  • Health resource utilization

    Annual number of inpatient days

    2015.01-2016.12

  • Costs of inpatient treatment

    Cost of COPD exacerbation inpatient treatment

    2015.01-2016.12

  • Health resource utilization

    Inpatient visit number

    2015.01-2016.12

  • Health resource utilization

    Emergency department (ED) visit number

    2015.01-2016.12

  • Costs of inpatient treatment

    Cost of all-cause inpatient treatment

    2015.01-2016.12

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of patients diagnosed with COPD in 2015 (a sub-group with exacerbation history will be used for primary, secondary and the first exploratory objectives analysis) and having continuous usage of COPD maintenance therapy during the 1 year follow-up period.

You may qualify if:

  • Patients diagnosed with COPD in 2015;
  • Patients had complete hospital visit data available during pre-index 1 year period and post 1 year follow-up;
  • Patients had at least one COPD exacerbation during 1 year prior to the index date;
  • Patients had at least 2 COPD maintenance medication claims during post index 1 year period, as 2 claims are recommended to calculate adherence.

You may not qualify if:

  • Inability to determine diagnoses from claims;
  • Individuals with other chronic respiratory conditions such as respiratory cancer, pulmonary fibrosis, asthma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research site

Beijing, 100000, China

Location

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

November 8, 2017

First Posted

December 2, 2017

Study Start

June 7, 2018

Primary Completion

August 20, 2018

Study Completion

August 20, 2018

Last Updated

July 30, 2019

Record last verified: 2019-07

Locations