ICS/LABA Adherence and COPD Exacerbation | NCT02446041

Studies
ICS/LABA Adherence and COPD Exacerbation

NCT02446041

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Oct 11, 2016Estimated

Enrollment

10,000Actual

Phase

Not provided

Conditions

Pulmonary Disease
Chronic Obstructive

Interventions

Non-Interventional Study

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

Oct 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

May 13, 2015

First Submission Date that Met QC Criteria

May 14, 2015

First Posted Date

May 15, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2016

Last Update Posted Date

Oct 11, 2016Estimated

Name	Class
Carelon Research	OTHER

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ICS/LABA Patients		ICS/LABA Patients following standard of care	Other: Non-Interventional Study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-Interventional Study	Other	Non-Interventional Study	ICS/LABA Patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

ICS/LABA patients with administrative claims data from health plans in the Northeast, Midwest, South and West United States.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frank Trudo, MD	AstraZeneca	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Facility		Wilmington	Delaware		United States

Label	URL
CSR Synopsis	View source

Condition Browse Module

MeSH Terms

ID	Term
D008171	Lung Diseases
D029424	Pulmonary Disease, Chronic Obstructive
D029481	Bronchitis, Chronic
D011656	Pulmonary Emphysema

Ancestor Terms

ID	Term
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D002908	Chronic Disease
D020969	Disease Attributes

Browse Leaves

Not provided

Browse Branches

Not provided