Clinical trial NCT04926233: Characteristics and Treatment Patterns of Patients With Chronic Obstructive Pulmonary Disease (COPD), Initiating Tio+Olo or Other Maintenance Therapies in the US and the UK: A Retrospective Claims Database Study
Official title: Characteristics and Treatment Patterns of Patients With Chronic Obstructive Pulmonary Disease (COPD), Initiating Tio+Olo or Other Maintenance Therapies in the US and the UK: A Retrospective Claims Database Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2021-06-15
Enrollment: 1371146
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population for the analysis will consist of all patients with at least one medical claim with a diagnosis code of COPD identified.

Brief summary: The primary objectives of the study are to use US and UK data to describe the characteristics of Chronic Obstructive Pulmonary Disease (COPD) patients according to various demographic, lifestyle, clinical, and medication use.


Eligibility criteria: Inclusion criteria:

* parent cohort

  -- COPD diagnosis
* child cohort

  -- any initiation of first maintenance therapy after July 1, 2015
* grandchild cohort -- any initiation of second maintenance therapy after August 2, 2015

Exclusion criteria:

- parent cohort

* age \<40 on index date
* any COPD diagnosis in baseline
* any use of long-acting muscarinic antagonists (LAMA), long-acting beta-agonists (LABA), or inhaled corticosteroid (ICS) in baseline
* \<365 days of continuous medical and pharmacy coverage

Primary outcomes:
measure: Age of the Chronic Obstructive Pulmonary Disease (COPD) Patients at the Time of COPD Diagnosis - US
timeFrame: At index date of cohort entry (baseline; time of COPD diagnosis).
measure: Age of the Chronic Obstructive Pulmonary Disease (COPD) Patients at the Time of COPD Diagnosis - UK
timeFrame: At index date of cohort entry (baseline; time of COPD diagnosis).
measure: Charlson Comorbidity Index (CCI) at the Time of COPD Diagnosis
timeFrame: At index date of cohort entry (baseline; time of COPD diagnosis).
measure: Age of Patients Receiving First Maintenance Treatment - US
timeFrame: At index date of the first maintenance treatment
measure: Charlson Comorbidity Index (CCI) of Patients Receiving First Maintenance Treatment - US
timeFrame: At index date of the first maintenance treatment
measure: Characteristics of Patients Receiving First Maintenance Treatment - US
timeFrame: At index date of the first maintenance treatment
measure: Age of Patients Receiving First Maintenance Treatment - UK
timeFrame: At index date of the first maintenance treatment
measure: Characteristics of Patients Receiving First Maintenance Treatment - UK
timeFrame: At index date of the first maintenance treatment
measure: Age of Patients Receiving Second Maintenance Treatment - US
timeFrame: At index date of the second maintenance treatment
measure: Charlson Comorbidity Index (CCI) of Patients Receiving Second Maintenance Treatment - US
timeFrame: At index date of the second maintenance treatment
measure: Characteristics of Patients Receiving Second Maintenance Treatment - US
timeFrame: At index date of the second maintenance treatment
measure: Age of Patients Receiving Second Maintenance Treatment - UK
timeFrame: At index date of the second maintenance treatment
measure: Characteristics of Patients Receiving Second Maintenance Treatment - UK
timeFrame: At index date of the second maintenance treatment
Secondary outcomes:
measure: Number of Participants With Zero Exacerbations in the Year Prior to the Start of First Maintenance Therapy - US
timeFrame: At index date of the first maintenance treatment
measure: Number of Participants With Zero Exacerbations in the Year Prior to the Start of First Maintenance Therapy - UK
timeFrame: At index date of the first maintenance treatment
measure: Number of Participants With Zero Exacerbations in the Year Prior to the Start of Second Maintenance Therapy - US
timeFrame: At index date of the second maintenance treatment
measure: Number of Participants With Zero Exacerbations in the Year Prior to the Start of Second Maintenance Therapy - UK
timeFrame: At index date of the second maintenance treatment
measure: Days Between Index and Initiation of First Maintenance Therapy - US
timeFrame: From index date until initiation of first maintenance, up to 3368 days before this study started.
measure: Days Between Index and Initiation of First Maintenance Therapy - UK
timeFrame: From index date until initiation of first maintenance therapy, up to 9795 days before this study started.
measure: Days Between First and Second Maintenance Therapy - US
timeFrame: From the index date of first maintenance initiation until the initiation of the second maintenance therapy, up to 1020 days before this study started.
measure: Days Between First and Second Maintenance Therapy - UK
timeFrame: From the index date of first maintenance initiation until the initiation of the second maintenance therapy, up to 10133 days before this study started.
Other outcomes:
Locations:
city: New York
country: United States
facility: AETION inc
state: New York
Study officials:
References: