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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

May 13, 2015
May 15, 2015
October 11, 2016
May 2015
October 2015   (Final data collection date for primary outcome measure)
Exacerbation rate [ Time Frame: 12 months ]
Rate of COPD exacerbation occurring during the 12 months after therapy initiation.
Same as current
Complete list of historical versions of study NCT02446041 on ClinicalTrials.gov Archive Site
Severe Exacerbation rate [ Time Frame: 12 months ]
Severe exacerbation rate during the 12 months after therapy initiation
Same as current
Time to Exacerbation [ Time Frame: 12 months ]
Time to first COPD exacerbation during the 12 months after therapy initiation.
Same as current
 
ICS/LABA Adherence and COPD Exacerbation
Adherence and COPD Exacerbation Rates in Patients Initiating ICS/LABA Therapy.
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
ICS/LABA patients with administrative claims data from health plans in the Northeast, Midwest, South and West United States.
  • Pulmonary Disease
  • Chronic Obstructive
Other: Non-Interventional Study
Non-Interventional Study
ICS/LABA Patients
ICS/LABA Patients following standard of care
Intervention: Other: Non-Interventional Study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10000
Same as current
October 2015
October 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years to 99 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02446041
D589BR00034
Not Provided
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Healthcore
Study Chair: Frank Trudo, MD AstraZeneca
AstraZeneca
October 2016