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Completed

NCT Number: 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

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.

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AETION inc

New York, 10018, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Tiotropium bromide + Olodaterol

Drug

Tiotropium bromide + Olodaterol

Other names: Sp(t)iolto® Respimat®

Sp(t)iolto® Respimat®

Device

Sp(t)iolto® Respimat®

Primary outcomes

  1. Age of the Chronic Obstructive Pulmonary Disease (COPD) Patients at the Time of COPD Diagnosis - US

    Time frame: At index date of cohort entry (baseline; time of COPD diagnosis).

    Age of the chronic obstructive pulmonary disease (COPD) patients at the time of COPD diagnosis from the United States (US) IBM MarketScan was reported by groups stratified according to their COPD diagnosis times (Before versus after the approval of Tiotropium + Olodaterol in 2015).

  2. Age of the Chronic Obstructive Pulmonary Disease (COPD) Patients at the Time of COPD Diagnosis - UK

    Time frame: At index date of cohort entry (baseline; time of COPD diagnosis).

    Age of the chronic obstructive pulmonary disease (COPD) patients at the time of COPD diagnosis from the the United Kingdom (UK) CPRD GOLD database was reported by groups stratified according to their COPD diagnosis times (Before versus after the approval of Tiotropium + Olodaterol in 2015).

  3. Charlson Comorbidity Index (CCI) at the Time of COPD Diagnosis

    Time frame: At index date of cohort entry (baseline; time of COPD diagnosis).

    The Charlson Comorbidity Index (CCI) was a method of categorizing comorbidities of patients based on the International Classification of Diseases diagnosis. The CCI score ranged from 0 (better outcome) to 21 (worse outcome). The higher the score, the more fragile/ill the patient was.

  4. Age of Patients Receiving First Maintenance Treatment - US

    Time frame: At index date of the first maintenance treatment

    Age of chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United States (US) IBM MarketScan database was reported.

  5. Charlson Comorbidity Index (CCI) of Patients Receiving First Maintenance Treatment - US

    Time frame: At index date of the first maintenance treatment

    The Charlson Comorbidity Index (CCI) was a method of categorizing comorbidities of patients based on the International Classification of Diseases diagnosis. The CCI score ranged from 0 (better outcome) to 21 (worse outcome). The higher the score, the more fragile/ill the patient was.

  6. Characteristics of Patients Receiving First Maintenance Treatment - US

    Time frame: At index date of the first maintenance treatment

    Characteristics of patients receiving first maintenance treatment among chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United States (US) IBM MarketScan database were reported.

  7. Age of Patients Receiving First Maintenance Treatment - UK

    Time frame: At index date of the first maintenance treatment

    Age of patients receiving first maintenance treatment from chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United Kingdom (UK) CPRD GOLD database was reported.

  8. Characteristics of Patients Receiving First Maintenance Treatment - UK

    Time frame: At index date of the first maintenance treatment

    Characteristics of patients receiving first maintenance treatment from chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United Kingdom (UK) CPRD GOLD database were reported.

  9. Age of Patients Receiving Second Maintenance Treatment - US

    Time frame: At index date of the second maintenance treatment

    Age of patients receiving second maintenance treatment from the United States (US) IBM MarketScan database was reported.

  10. Charlson Comorbidity Index (CCI) of Patients Receiving Second Maintenance Treatment - US

    Time frame: At index date of the second maintenance treatment

    The Charlson Comorbidity Index (CCI) was a method of categorizing comorbidities of patients based on the International Classification of Diseases diagnosis. The CCI score ranged from 0 (better outcome) to 21 (worse outcome). The higher the score, the more fragile/ill the patient was.

  11. Characteristics of Patients Receiving Second Maintenance Treatment - US

    Time frame: At index date of the second maintenance treatment

    Characteristics of patients receiving second maintenance treatment from chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy in the United States (US) IBM MarketScan database were reported.

  12. Age of Patients Receiving Second Maintenance Treatment - UK

    Time frame: At index date of the second maintenance treatment

    Age of patients receiving second maintenance treatment from chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy in the United Kingdom (UK) CPRD GOLD database was reported.

  13. Characteristics of Patients Receiving Second Maintenance Treatment - UK

    Time frame: At index date of the second maintenance treatment

    Characteristics of patients receiving second maintenance treatment from chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy in the United Kingdom (UK) CPRD GOLD database were reported.

Secondary outcomes

  1. Number of Participants With Zero Exacerbations in the Year Prior to the Start of First Maintenance Therapy - US

    Time frame: At index date of the first maintenance treatment

    Number of participants with zero exacerbations in the year prior to the start of first maintenance therapy among the chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy the United States (US) IBM MarketScan database was reported.

  2. Number of Participants With Zero Exacerbations in the Year Prior to the Start of First Maintenance Therapy - UK

    Time frame: At index date of the first maintenance treatment

    Number of participants with zero exacerbations in the year prior to the start of first maintenance therapy among the chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United Kingdom (UK) CPRD GOLD database was reported.

  3. Number of Participants With Zero Exacerbations in the Year Prior to the Start of Second Maintenance Therapy - US

    Time frame: At index date of the second maintenance treatment

    Number of participants with zero exacerbations in the year prior to the start of second maintenance therapy among the chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy the United States (US) IBM MarketScan database was reported.

  4. Number of Participants With Zero Exacerbations in the Year Prior to the Start of Second Maintenance Therapy - UK

    Time frame: At index date of the second maintenance treatment

    Number of participants with zero exacerbations in the year prior to the start of second maintenance therapy among chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy in the United Kingdom (UK) CPRD GOLD database was reported.

  5. Days Between Index and Initiation of First Maintenance Therapy - US

    Time frame: From index date until initiation of first maintenance, up to 3368 days before this study started.

    Days between index and initiation of first maintenance therapy among the chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy the United States (US) IBM MarketScan database was reported.

  6. Days Between Index and Initiation of First Maintenance Therapy - UK

    Time frame: From index date until initiation of first maintenance therapy, up to 9795 days before this study started.

    Days between index and initiation of first maintenance therapy among the chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United Kingdom (UK) CPRD GOLD database were reported.

  7. Days Between First and Second Maintenance Therapy - US

    Time frame: From the index date of first maintenance initiation until the initiation of the second maintenance therapy, up to 1020 days before this study started.

    Days between first and second maintenance therapy among the chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy the United States (US) IBM MarketScan database were reported.

  8. Days Between First and Second Maintenance Therapy - UK

    Time frame: From the index date of first maintenance initiation until the initiation of the second maintenance therapy, up to 10133 days before this study started.

    Days between first and second maintenance therapy among chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy in the United Kingdom (UK) CPRD GOLD database were reported.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 15, 2021
Registry last updated
Nov 15, 2021

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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