Pulmonary Disease, Chronic ObstructiveNCT06053541
Morbid Rates After Spiriva Chronic Obstructive Pulmonary Disease (COPD) Protocol Change
An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 1 site in Brazil.
Trial summary
This study evaluates hospitalizations and mortality in patients with Chronic Obstructive Pulmonary Disease (COPD) before and after the implantation of a new COPD treatment plan (replacement of tiotropium soft mist inhaler for glycopyrronium dry powder inhaler) by the Health State Secretariat of Federal District in… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- How many people
- 3,015,000 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2021to 1 Jul 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 40 years of age, diagnosed with Chronic Obstructive Pulmonary Disease (COPD), admitted to the hospital with acute exacerbations of the disease between August 2017 and July 2019 in Federal District, Brazil.
Who may be able to join
- Patients older than 40 years of age at the time of hospital admission
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to the International Statistical Classification of Diseases and Related Health Problems Version 10 (ICD-10) established by the Health Care Protocol of the Health Secretariat of Federal District (SES/DF), with the following codes:
- J41.0 - Simple chronic bronchitis
- J41.1 - Mucopurulent chronic bronchitis
- J41.8 - Mixed simple and mucopurulent chronic bronchitis
- J42 - Unspecified chronic bronchitis
Show all 14Show fewer
- J43.1 - Panlobular emphysema
- J43.2 - Centrilobular emphysema
- J43.8 - Other emphysema
- J43.9 - Emphysema, unspecified
- J44.0 - Chronic obstructive pulmonary disease with acute lower respiratory infection
- J44.1 - Chronic obstructive pulmonary disease with acute exacerbation, unspecified
- J44.8 - Other specified chronic obstructive pulmonary disease
- J44.9 - Chronic obstructive pulmonary disease, unspecified
Who cannot join
- Patients younger than 40 yeas of age at the time of hospital admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hospitalization, Mortality Rates and Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) in Distrito Federal, Brazil, Before and After the Change in 2018 State COPD Protocol Version - Real-world Data
This study evaluates hospitalizations and mortality in patients with Chronic Obstructive Pulmonary Disease (COPD) before and after the implantation of a new COPD treatment plan (replacement of tiotropium soft mist inhaler for glycopyrronium dry powder inhaler) by the Health State Secretariat of Federal District in Brazil.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with COPD, admitted to the hospital with acute exacerbations | Patients over 40 years of age, diagnosed with Chronic Obstructive Pulmonary Disease (COPD), admitted to the hospital with acute exacerbations as recorded in the DATASUS (Unified Health Brazilian System Informatics Department (in Portuguese) between August 2017 and July 2019. Patients were treated with either Tiotropium bromide in soft mist inhaler (SPIRIVA® RESPIMAT®) or with Glycopyrronium bromide in dry powder inhaler (Seebri® Breezhaler®) as part of the treatment plan for Chronic Obstructive Pulmonary Disease (COPD) defined by the Health State Secretariat of Distrito Federal (DF) in Brazil. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Hospital Admissions in Chronic Obstructive Pulmonary Disease (COPD) Patients
Number of hospital admissions in Chronic Obstructive Pulmonary Disease (COPD) patients, is reported, the same patient could be hospitalized more than once a year.
Measured: From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.
Number of Deaths of Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients
Number of deaths of hospitalized Chronic Obstructive Pulmonary Disease (COPD) patients, the same patient could be hospitalized more than once a year.
Measured: From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.
Total Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations
Total accumulated costs to the payer per year associated with Chronic Obstructive Pulmonary Disease (COPD) hospitalizations, is reported, the same patient could have been hospitalized more than once a year. No individual costs, the cost reported are the total spent per year.
Measured: From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.
Infirmary Beds
Average monthly number of available Infirmary beds, including available general and ICU (Intensive care unit) beds are reported, the same patient could have been hospitalized more than once a year.
Measured: From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.
Secondary outcomes (2)
Number of Hospitalizations With Intensive Care Unit (ICU) Admissions Over Total Number of Hospitalizations
Number of hospitalizations with intensive care unit (ICU) admissions over total number of hospitalizations, is reported, the same patient could have been hospitalized more than once a year.
Measured: From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.
Total Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations With Admission to Intensive Care Unit (ICU)
Total costs associated with Chronic Obstructive Pulmonary Disease (COPD) hospitalizations with admission to intensive care unit (ICU) , is reported, the same patient could have been hospitalized more than once a year.
Measured: From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start1 Apr 2021
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,015,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053541
- Sponsor's protocol ID
- 0205-0548
- Status last verified
- Oct 2024
- First submitted
- 18 Sep 2023
- Last updated
- 26 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospitalization, Mortality Rates and Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) in Distrito Federal, Brazil, Before and After the Change in 2018 State COPD Protocol Version - Real-world Data
- ClinicalTrials.gov ID
- NCT06053541
- Acronym / sponsor ID
- 0205-0548
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,015,000 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 25 Sep 2023 (actual)
- Results
- Posted 26 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates hospitalizations and mortality in patients with Chronic Obstructive Pulmonary Disease (COPD) before and after the implantation of a new COPD treatment plan (replacement of tiotropium soft mist inhaler for glycopyrronium dry powder inhaler) by the Health State Secretariat of Federal District in Brazil.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with COPD, admitted to the hospital with acute exacerbations | – | –Patients over 40 years of age, diagnosed with Chronic Obstructive Pulmonary Disease (COPD), admitted to the hospital with acute exacerbations as recorded in the DATASUS (Unified Health Brazilian System Informatics Department (in Portuguese) between August 2017 and July 2019. Patients were treated with either Tiotropium bromide in soft mist inhaler (SPIRIVA® RESPIMAT®) or with Glycopyrronium bromide in dry powder inhaler (Seebri® Breezhaler®) as part of the treatment plan for Chronic Obstructive Pulmonary Disease (COPD) defined by the Health State Secretariat of Distrito Federal (DF) in Brazil. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 40 years of age, diagnosed with Chronic Obstructive Pulmonary Disease (COPD), admitted to the hospital with acute exacerbations of the disease between August 2017 and July 2019 in Federal District, Brazil.
Key inclusion criteria (14 listed)
- Patients older than 40 years of age at the time of hospital admission
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to the International Statistical Classification of Diseases and Related Health Problems Version 10 (ICD-10) established by the Health Care Protocol of the Health Secretariat of Federal District (SES/DF), with the following codes:
Key exclusion criteria (1 listed)
- Patients younger than 40 yeas of age at the time of hospital admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Hospital Admissions in Chronic Obstructive Pulmonary Disease (COPD) Patients
Time frame: From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.
Number of hospital admissions in Chronic Obstructive Pulmonary Disease (COPD) patients, is reported, the same patient could be hospitalized more than once a year.
Number of Deaths of Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients
Time frame: From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.
Number of deaths of hospitalized Chronic Obstructive Pulmonary Disease (COPD) patients, the same patient could be hospitalized more than once a year.
Total Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations
Time frame: From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.
Total accumulated costs to the payer per year associated with Chronic Obstructive Pulmonary Disease (COPD) hospitalizations, is reported, the same patient could have been hospitalized more than once a year. No individual costs, the cost reported are the total spent per year.
Infirmary Beds
Time frame: From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.
Average monthly number of available Infirmary beds, including available general and ICU (Intensive care unit) beds are reported, the same patient could have been hospitalized more than once a year.
2 secondary outcomes
Number of Hospitalizations With Intensive Care Unit (ICU) Admissions Over Total Number of Hospitalizations
Time frame: From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.
Total Costs Associated With Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations With Admission to Intensive Care Unit (ICU)
Time frame: From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Hospital Admissions in Chronic Obstructive Pulmonary Disease (COPD) Patients (time frame: From August 2017 to July 2018 (Tiotropium treatment - MAT1 period) and August 2018 to July 2019 (Glycopyrronium treatment - MAT2 Period), Up to 1 year.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.