ICS/LABA Adherence and COPD Exacerbation

Adherence and COPD Exacerbation Rates in Patients Initiating ICS/LABA Therapy.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02446041

Enrollment

10000

Registered

2015-05-15

Start date

2015-05-31

Completion date

2015-10-31

Last updated

2016-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive, Pulmonary Disease

Keywords

COPD, Chronic Bronchitis, Pulmonary Emphysema

Brief summary

The purpose of this retrospective, non-interventional sutdy is to compare the effectiveness of ICS/LABA combination therapy in the reduction of COPD exacerbations during the 12 months after initiation of therapy between COPD patients who are adherent to the index medication and those who are non-adherent.

Detailed description

This retrospective, observational study will assess the effectiveness of ICS/LABA combination therapies among COPD patients new to the ICS/LABA combination therapies in the US, comparing those who are adherent to the index medication and those who are non-adherent. Adherence will be measured using the proportion of days covered with the index medication. Medical and pharmacy claims data will be used as the data source.

Interventions

OTHERNon-Interventional Study

Non-Interventional Study

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 99 Years

Healthy volunteers

Inclusion criteria

* at least one prescription fill for ICS/LABA combination during identification period. * COPD diagnosis * 40 years or older at index date * \> or = 12 months of continuous health plan enrollment prior to and following index date * 1 or more prescription for SABA, SAMA or SABA/SAMA during the pre-index period.

Exclusion criteria

* Patients with prescription claim for ICS/LABA combination therapy during the 12 month pre-index period * Patients receiving oral corticosteroid medication for more than 180 days during the 12 month pre-index period * Patients with cancer diagnosis in 12 month pre-index period

Design outcomes

Primary

Measure	Time frame	Description
Exacerbation rate	12 months	Rate of COPD exacerbation occurring during the 12 months after therapy initiation.

Secondary

Measure	Time frame	Description
Severe Exacerbation rate	12 months	Severe exacerbation rate during the 12 months after therapy initiation

Other

Measure	Time frame	Description
Time to Exacerbation	12 months	Time to first COPD exacerbation during the 12 months after therapy initiation.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026