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OpenTrials
Completed

NCT Number: NCT02446041

ICS/LABA Adherence and COPD Exacerbation

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.

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Key information

Conditions

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

Age range

40 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Facility

Wilmington, Delaware, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Non-Interventional Study

Primary outcomes

  1. Exacerbation rate

    Time frame: 12 months

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

Secondary outcomes

  1. Severe Exacerbation rate

    Time frame: 12 months

    Severe exacerbation rate during the 12 months after therapy initiation

Other outcomes

  1. Time to Exacerbation

    Time frame: 12 months

    Time to first COPD exacerbation during the 12 months after therapy initiation.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Carelon Research

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 15, 2015
Registry last updated
Oct 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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