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

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ClinicalTrials.gov Identifier: NCT04097223
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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.

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Drug: Long-acting beta agonist + Long-acting muscarinic antagonist Drug: Long-acting beta agonist + Long-acting muscarinic antagonist+Inhaled corticosteriods

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Study Type : Observational
Estimated Enrollment : 40000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Real-world Treatment of Newly Diagnosed COPD Patients: A Retrospective German Claims Data Analysis
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 2, 2020
Estimated Study Completion Date : October 2, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Group/Cohort Intervention/treatment
Subjects with Pulmonary Disease, Chronic Obstructive Drug: Long-acting beta agonist + Long-acting muscarinic antagonist
drug
Other Name: Olodaterol and tiotropium bromide

Drug: Long-acting beta agonist + Long-acting muscarinic antagonist+Inhaled corticosteriods
drug




Primary Outcome Measures :
  1. Incidence of COPD [ Time Frame: Up to 36 months ]

Secondary Outcome Measures :
  1. Assessment of treatment of COPD-12 and COPD diseases management program (DMP)-12 patients with two versions of German treatment guidelines (2012/2018) [ Time Frame: At index date ]
    All incident COPD patients with a follow-up of 12 months since index date

  2. Assessment of treatment of COPD-12 and COPD diseases management program (DMP)-12 patients with two versions of German treatment guidelines (2012/2018) [ Time Frame: Up to 12 months ]
    All incident COPD patients with available DMP data (at least one entry during 3 months after index date) and a follow-up of 12 months since index date

  3. Frequency of exacerbation [ Time Frame: Up to 36 months ]
  4. treatment costs of COPD patients, other medications, Outpatient treatment, Hospitalizations, Long-Term Oxygen Therapy (LTOT) [ Time Frame: Up to 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A retrospective analysis of patients with Chronic Obstructive Pulmonary Disease (COPD) based on current German COPD guidleines.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097223


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04097223     History of Changes
Other Study ID Numbers: 1237-0092
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

  1. Studies in products where Boehringer Ingelheim is not the license holder
  2. Studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials
  3. Studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

Requestors can use the following link http://trials.boehringer-ingelheim.com/


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive
Tiotropium Bromide
Cholinergic Agents
Muscarinic Antagonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action