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ICS/LABA Adherence and COPD Exacerbation

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ClinicalTrials.gov Identifier: NCT02446041
Recruitment Status : Completed
First Posted : May 15, 2015
Last Update Posted : October 11, 2016
Sponsor:
Collaborator:
Healthcore
Information provided by (Responsible Party):
AstraZeneca

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.

Condition or disease Intervention/treatment
Pulmonary Disease Chronic Obstructive Other: Non-Interventional Study

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.

Study Type : Observational
Actual Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Adherence and COPD Exacerbation Rates in Patients Initiating ICS/LABA Therapy.
Study Start Date : May 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Group/Cohort Intervention/treatment
ICS/LABA Patients
ICS/LABA Patients following standard of care
Other: Non-Interventional Study
Non-Interventional Study




Primary Outcome Measures :
  1. Exacerbation rate [ Time Frame: 12 months ]
    Rate of COPD exacerbation occurring during the 12 months after therapy initiation.


Secondary Outcome Measures :
  1. Severe Exacerbation rate [ Time Frame: 12 months ]
    Severe exacerbation rate during the 12 months after therapy initiation


Other Outcome Measures:
  1. Time to Exacerbation [ Time Frame: 12 months ]
    Time to first COPD exacerbation during the 12 months after therapy initiation.



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Ages Eligible for Study:   40 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02446041


Locations
United States, Delaware
Research Facility
Wilmington, Delaware, United States
Sponsors and Collaborators
AstraZeneca
Healthcore
Investigators
Study Chair: Frank Trudo, MD AstraZeneca

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02446041     History of Changes
Other Study ID Numbers: D589BR00034
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: October 2016

Keywords provided by AstraZeneca:
COPD
Chronic Bronchitis
Pulmonary Emphysema

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases