Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT01331694
Eligibility Criteria:
Inclusion Criteria -
IMT Cohorts (subjects selected by order of criteria)
* claim for one of the study medications and must not receive another study medication within 60 days of the initial maintenance therapy, indicating "intent to treat."
* at least one COPD-related ED or one COPD-related hospitalization, or two COPD-related outpatient visits (OV) associated with primary or secondary diagnosis for COPD (ICD-9-CM code 491.xx, 492.xx or 496.xx), at any time during the observation period (July 1, 2005 through June 30, 2008) in the database.
* Aged 65+ years on the index date or aged 40 and over for the sub-analysis.
* Continuous enrollment in a health plan for at least 6 months prior (pre-index) to initiation of IMT and at least three months after the first initiation of IMT (post-index).
* at least one prescription claim in the pre-index and each year of the post-index period for which they have follow-up.
Exclusion Criteria - All Cohorts
* primary or secondary diagnosis of respiratory tract cancer (larynx, trachea, or pleura). (ICD-9-CM codes 161, 161.X, 162, 163, 163.X, 231, 231.X).
* In the pre-index period, no claims for any of the cohort IMT medications, nor for any other Advair or budesonide/formoterol fixed dose combination, FSC combination medications, and may only have respiratory medication pharmacy claims for drugs included in the pre-index severity of illness assessment (Methylxanthines, Leukotriene Modifiers/Inhibitors, Omalizumab and Mast Cell Stabilizers).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT01331694
Study Brief:
Protocol Section:
NCT01331694