ICS/LABA Adherence and COPD Exacerbation

NCT02446041 | Completed

• 1 other identifier: D589BR00034
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease; Chronic Obstructive

Keywords

COPD; Chronic Bronchitis; Pulmonary Emphysema

Outcome Measures

Primary Outcomes (1)

• Exacerbation rate

  Rate of COPD exacerbation occurring during the 12 months after therapy initiation.

  12 months

Secondary Outcomes (1)

• Severe Exacerbation rate

  12 months

Other Outcomes (1)

• Time to Exacerbation

  12 months

Study Arms (1)

ICS/LABA Patients

ICS/LABA Patients following standard of care

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-Interventional Study

ICS/LABA Patients

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• Carelon Research: collaborator

Study Sites (1)

Research Facility

Wilmington, Delaware, United States

Location

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Lung Diseases; Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic; Pulmonary Emphysema

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Study Officials

• Frank Trudo, MD

  AstraZeneca

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2015
• First Posted: May 15, 2015
• Study Start: May 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 11, 2016

Record last verified: 2016-10

Locations

US (1)