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Completed

NCT Number: NCT04097223

A Study Based on Health Insurance Data About the Treatment of Patients Who Have Been Newly Diagnosed With Chronic Obstructive Pulmonary Disease (COPD)

A retrospective analysis study in COPD patients for an exact follow-up period of 12 months (in subgroup analyses: 24 and 36 months); censoring of patients will only be done in case a patient died during the respective follow-up period.

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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

Institute for pharmacoeconomics and pharmaceutical logistics e.V (IPAM)

Wismar, 23966, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients who were continuously insured by the sickness fund for the entire period (01/01/2013-30/06/2018) or, in case a patient deceased after index date, for the time until death
  • A patient will be included as an incident COPD patient if either a hospital documented at least one COPD diagnosis (International Statistical Classification of Diseases and Related Health Problems (ICD-10 J 44.-) or a specialist (pneumologist) documented at least 2 confirmed COPD diagnoses (above ICD-10) code) in two different quarters; the first of the above diagnoses is defined as index diagnosis; inclusion period is defined as lasting from 01/01/2014 until 30/06/2017
  • Patients should not have received any COPD diagnosis (ICD-10 J44.-) or any COPD-associated medication in the 12 months pre-index period
  • Patient should have, at date of incident COPD diagnosis (index date), an age of at least 40 years

Exclusion criteria

  • Patients received , at least one confirmed inpatient asthma diagnosis or two confirmed outpatient diagnoses of asthma (ICD-10: J45) by pneumologists

Treatment and study plan

Primary outcomes

  1. Description of Real-life Drug Treatment After Incident Diagnosis - COPD-12 Sample

    Time frame: Up to 12 months after the index date.

    Description of real-life drug treatment in patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD) in the first 12 months after the index date (date of incident (first) diagnosis of COPD). Reported is the percentage of patients per treatment and therapy line. The arms are not mutually exclusive, as patients switched to another treatment during follow-up period.

    COPD-12 sample: Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 12 months since index date (COPD-12).

    LABA: Long-acting beta agonist; LAMA: Long-acting muscarinic antagonist, ICS: Inhaled corticosteroids.

  2. Description of Real-life Drug Treatment After Incident Diagnosis - COPD-24 Sample

    Time frame: Up to 24 months after the index date.

    Description of real-life drug treatment in patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD) in the first 24 months after the index date (date of incident (first) diagnosis of COPD). Reported is the percentage of patients per treatment and therapy line. The arms are not mutually exclusive, as patients switched to another treatment during follow-up period.

    COPD-24 sample: Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 24 months since index date (COPD-24).

    LABA: Long-acting beta agonist; LAMA: Long-acting muscarinic antagonist, ICS: Inhaled corticosteroids.

  3. Description of Real-life Drug Treatment After Incident Diagnosis - COPD-36 Sample

    Time frame: Up to 36 months after the index date.

    Description of real-life drug treatment in patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD) in the first 36 months after the index date (date of incident (first) diagnosis of COPD). Reported is the percentage of patients per treatment and therapy line. The arms are not mutually exclusive, as patients switched to another treatment during follow-up period.

    COPD-36 sample: Patients with chronic obstructive pulmonary disease (COPD) included in german claims database between april 2015 and march 2018, with follow-up of 36 months since index date (COPD-36).

    LABA: Long-acting beta agonist; LAMA: Long-acting muscarinic antagonist, ICS: Inhaled corticosteroids.

  4. Number of Observed Treatment Lines - COPD-12, COPD-24, COPD-36 and COPD-FULL Sample

    Time frame: Up to 12, 24, 36 and 48 months after index date for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively.

    Number of treatment lines an observed patient received in the first 12/24/36 and 48 months after incident diagnosis.

  5. Percentage of Patients Per Most Frequently Prescribed Non-COPD Agents in COPD-FULL, COPD-12, COPD-24 and COPD-36 Samples

    Time frame: Up to 12, 24, 36 and 48 months after index date for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively.

    Percentage of participants per most frequently prescribed non-COPD agents in the first 12/24/36 and 48 months after incident diagnosis.

    GERD: Gastroesophageal reflux disease.

Secondary outcomes

  1. Percentage of Incident COPD-patients With Initial Treatment Not in Line Treatment Guideline - COPD-12 Sample

    Time frame: At index date.

    Percentage of incident chronic obstructive pulmonary disease (COPD) patients with initial drug treatment not in line with 2012/2018 german guidelines. Results are reported for COPD-12 sample. According to guidelines the initial treatment with long-acting bronchodilators should generally not include use of Inhaled corticosteroids (ICS) (both guidelines). Based on the 2012 guideline, a therapy with long-acting bronchodilators should not start with a combination of Long-acting beta agonist (LABA) + Long-acting muscarinic antagonist (LAMA) or triple therapy of LAMA+LABA+ ICS.

  2. Percentage of Incident COPD-patients With Treatment Not in Line Treatment Guideline - COPD-12 Sample (Triple Therapy)

    Time frame: At first day of triple therapy prescription, (which is not the index date), up to 12 months.

    Percentage of incident chronic obstructive pulmonary disease (COPD) patients with drug treatment not in line with 2012/2018 german guidelines. Results are reported for COPD-12 sample, who received triple therapy (Long-acting beta agonist (LABA) + Long-acting muscarinic antagonist (LAMA) + Inhaled corticosteroids (ICS)) within the first 12 months after incident diagnosis.

    According to both guidelines (2012/2018) a triple combination treatment should not be prescribed if only 1 or less confirmed outpatient diagnoses and no inpatient diagnosis of a COPD exacerbation (ICD-10 J44.1) before date of prescription of a triple therapy.

    FEV1: Forced expiratory volume (in 1 second).

  3. Percentage of Incident COPD-patients With Treatment Not in Line Treatment Guideline - COPD-12 Sample (Escalation Therapy)

    Time frame: Up to 12 months after index date.

    Percentage of incident chronic obstructive pulmonary disease (COPD) patients with drug treatment not in line with 2012/2018 german guidelines. Results are reported for patients in COPD-12 sample, with treatment escalation (mono therapy to Long-acting beta agonist (LABA)/ Long-acting muscarinic antagonist (LAMA)/ Inhaled corticosteroids (ICS), LABA/ICS or LAMA/LABA to LABA/LAMA/ICS) within the first 12 months after index date.

    According to guidelines patients should not receive a treatment intensification without any previous visit of a pneumologist or hospital (same quarter or previous quarter).

  4. Percentage of Patients With Exacerbations After Incident Diagnosis in COPD-12, COPD-24, COPD-36 and COPD-FULL Samples

    Time frame: Up to 12,24, 36 and 48 months after index date, for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively.

    Description of exacerbation (severe exacerbations associated with hospitalizations) frequency of patients with newly diagnosed (incident) chronic obstructive pulmonary disease (COPD) in the first 12, 24, 36 and 48 months after incident diagnosis.

    Reported is the percentage of patients with exacerbations by the following categories:

    More or equal than one exacerbation (≥ 1) ;

    • exacerbation;
    • exacerbations;
    • exacerbations; more than 3 exacerbations (> 3 exacerbations).

  5. Number of Yearly Visits Per Outpatient Treatment in COPD-12, COPD-24 and COPD-36 Samples

    Time frame: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.

    Description of health-care resource use (HCRU) in the first 12/24/36 months after incident diagnosis - Number of yearly visits (outpatient treatment).

    Following categories are reported:

    Number of yearly general practitioner (GP) visits; Number of yearly pulmonologist visits; Number of yearly other specialist (primarily Ophthalmologist, Ear, Nose and Throat (ENT) specialist and Orthopedist) visits.

    Reported is the average number of yearly visits, per observed patient year.

  6. Number of Yearly Hospitalizations in COPD-12, COPD-24 and COPD-36 Samples

    Time frame: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.

    Description of health-care resource use in the first 12/24/36 months after incident diagnosis: Number of yearly hospitalizations (inpatient treatment).

    Following categories of inpatient treatment are reported:

    Number of yearly hospitalizations with exacerbations (J44.1); Number of yearly hospitalizations with exacerbations, any COPD diagnosis (J44); Number of yearly hospitalizations with non-COPD diagnosis. Results are reported by follow-up time and available Disease Management Program (DMP) data.

  7. Time to First All-cause Hospitalization in COPD-12, COPD-24, COPD-36 Samples

    Time frame: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.

    Description of health-care resource use in the first 12/24/36 months after incident diagnosis in patients with chronic obstructive pulmonary disease (COPD). Reported is time to first all-cause hospitalization in days (inpatient treatment).

  8. Description of Direct Treatment Cost After Incident Diagnosis in COPD-12, COPD-24 and COPD-36 Samples

    Time frame: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.

    Description of direct treatment cost in the first 12/24/36 months after incident diagnosis - yearly costs in incident chronic obstructive pulmonary disease (COPD) patients.

    LTOT: Long-Term Oxygen Therapy.

  9. Prescription of Medication in COPD-12, COPD-24 and COPD-36 Samples

    Time frame: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.

    Description of health-care resource use in the first 12/24/36 months after incident diagnosis - Prescription of medication.

    Top-5 prescription of non-COPD medication:

    Beta-blocking agents; Anti-thrombotic agents; Other analgesics & antipyretics; High-ceiling diuretics; Drugs for peptic ulcer or Gastroesophageal reflux disease (GERD).

    Other prescriptions:

    Antibiotics for systemic use (ATC J02AA); Antibiotics + corticosteroids (ATC D07C). Reported is number of yearly prescription.

  10. Number of Patients With Long Term Oxygen Therapy (LTOT) in COPD-12, COPD-24 and COPD-36 Samples

    Time frame: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.

    Description of health-care resource use in the first 12/24/36 months after incident diagnosis - Number of Patients with Long Term Oxygen Therapy (LTOT).

  11. Time From Index Date Until Start of Long-term Oxygen Therapy (LTOT) - COPD-12, COPD-24 and COPD-36 Samples

    Time frame: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 sample respectively.

    Time from index date until start of long-term oxygen therapy (LTOT) in days in the first 12/24/36 months after incident diagnosis.

  12. Time From Index Date Until First Exacerbation - COPD-FULL, COPD-12, COPD-24 and COPD-36

    Time frame: Up to 12, 24, 36 and 48 months after index date for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively.

    Time from index date until first exacerbation, in the first 12/24/36/48 months after incident diagnosis. Only severe exacerbations leading to an inpatient hospitalization after index date (documented as main diagnosis: ICD-10 J44.1) are considered.

  13. Average Number of Yearly Exacerbations During Follow-up - COPD-FULL, COPD-12, COPD-24 and COPD-36

    Time frame: Up to 12, 24, 36 and 48 months after index date for COPD-12, COPD-24, COPD-36 and COPD-FULL sample respectively.

    Average number of yearly exacerbations in the first 12/24/36 and 48 months after incident diagnosis.

  14. Average Medication Costs Per Year - COPD-12, COPD-24 and COPD-36

    Time frame: Up to 12, 24 and 36 months after index date for COPD-12, COPD-24 and COPD-36 respectively.

    Description of yearly costs in incident chronic obstructive pulmonary disease (COPD) patients.

    Cost of non-COPD-medication are based on the top-10 prescribed on non-COPD drug therapies.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Real-world Treatment of Newly Diagnosed COPD Patients: A Retrospective German Claims Data Analysis

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 20, 2019
Registry last updated
Feb 24, 2022

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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