ClinicalTrials.gg
CompletedNCT03359122MARUUpdated Jul 30, 2019

Association of COPD Maintenance Medication Adherence With Resource Use and Cost Among COPD Patients

An observational study in Chronic Obstructive Pulmonary Disease (COPD), sponsored by AstraZeneca. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2019-07-30.

Sponsored by AstraZeneca · Observational

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Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
10,067
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 284 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca — 14 open to participants now, 15 under way, 4 of them phase 3. Pulmonary Disease, Chronic Obstructive · AstraZeneca.

Enrollment
12th of 89
10,067 · median 976
Started
2018
with 5 others
Observational
90 of 284
7 open now
Registered
212th of 284
by date

Among the 284 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca, this one is the 12th largest by enrollment of the 89 observational ones that give a count, is one of 6 that started in 2018, is one of 90 observational ones, and was the 212th registered.

Pulmonary Disease, Chronic Obstructive

5,522 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.

Browse Pulmonary Disease, Chronic Obstructive studies →

Open to participants now

14 of the 284 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:

9 more — sign in →

By country, each count listing its studies:

All 14 open studies →

Who these studies take

Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 89 take healthy volunteers.

This study: all sexes · no healthy volunteers.

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02

Study 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.

Read the detailed description

Objectives: The primary objective 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.

Study design: This study is a retrospective database analysis using 2014-2016 Guangzhou City health insurance database.

Data Source(s): Guangzhou city health insurance database will be used for this study. All outpatient and inpatient visits for one patient during 2014-2016 were available.

Study Population: This study will include patients with a physician COPD diagnosis in Guangzhou city health insurance database during 2015 and with complete treatment data during 1 year before and 1 year after the index date. The rough sample size of the study population was 49,000.

Outcome(s):

  1. Indicators of COPD control: exacerbations;
  2. Health resource utilization: annual number of inpatient days, inpatient visit number, emergency department (ED) visit number;
  3. Costs: COPD exacerbation hospitalization expenditures, all-cause hospitalization expenditure.

Statistical Analysis:

Descriptive statistics will be used for all variables, as appropriate. Continuous variables will be summarized by the number of observations, mean, standard deviation, median, minimum, maximum, first quartile and third quartile. Categorical variables will be summarized by frequency counts and percentages at each category. Number of patients and number of missing for each variable will be summarized.

Logistic regression will be used to estimate the risk of any hospitalization. Generalized Linear Models (GLMs) with a gamma distribution and log link will be used to approximate the highly right-skewed distribution of medical expenditure.

For exploratory objectives, Propensity Score Matching (PSM) will be used to explore the association of medication class and health resource utilization if applicable. The interaction of medication class * adherence or subgroup analysis (by medication class) will be considered when conducting the regression model.

03

Conditions studied

  • Chronic Obstructive Pulmonary Disease (COPD)
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Inability to determine diagnoses from claims;
  2. Individuals with other chronic respiratory conditions such as respiratory cancer, pulmonary fibrosis, asthma.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
10,067 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Indicators of COPD control

    Number of exacerbations

    Time frame: 2015.01-2016.12

  2. Health resource utilization

    Annual number of inpatient days

    Time frame: 2015.01-2016.12

  3. Costs of inpatient treatment

    Cost of COPD exacerbation inpatient treatment

    Time frame: 2015.01-2016.12

  4. Health resource utilization

    Inpatient visit number

    Time frame: 2015.01-2016.12

  5. Health resource utilization

    Emergency department (ED) visit number

    Time frame: 2015.01-2016.12

  6. Costs of inpatient treatment

    Cost of all-cause inpatient treatment

    Time frame: 2015.01-2016.12

07

Study locations

1 site
  • Research site
    Beijing, 100000, China
08

References and documents

Related links

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2018 to primary completion in Aug 2018, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 8, 2017
First posted
Dec 2, 2017
StartActual
Jun 7, 2018
Primary completionActual
Aug 20, 2018
CompletionActual
Aug 20, 2018
Last update
Jul 30, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03359122
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Dec 2, 2017
Start date
Jun 7, 2018
Primary completion
Aug 20, 2018
Completion
Aug 20, 2018
Last update
Jul 30, 2019

Oversight

Data monitoring committee
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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