Pulmonary Disease, Chronic ObstructiveNCT04926233

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

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Tiotropium bromide + Olodaterol and Sp(t)iolto® Respimat®
Type of treatment: Medical device
How many people: 1,371,146 participants
Where: 1 siteUnited States
Study dates: 15 Nov 2019to 14 Apr 2020
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: The study population for the analysis will consist of all patients with at least one medical claim with a diagnosis code of COPD identified.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

AETION inc
New York, New York, 10018

Other trials in United States

About this study

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Tiotropium bromide + Olodaterol, Sp(t)iolto® Respimat®
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.

Tiotropium bromide + OlodaterolDrug
Also called Sp(t)iolto® Respimat®
Tiotropium bromide + Olodaterol
Sp(t)iolto® Respimat®Device
Sp(t)iolto® Respimat®

Study groups in NCT04926233
Study group	Role	What they receive
COPD patients from US IBM Marketscan database		Not described Receives: Drug: Tiotropium bromide + Olodaterol; Device: Sp(t)iolto® Respimat®
COPD patients from UK CPRD GOLD database		Not described Receives: Drug: Tiotropium bromide + Olodaterol; Device: Sp(t)iolto® Respimat®

What is being measured

The primary outcome is the main question the study is designed to answer.

Age of the Chronic Obstructive Pulmonary Disease (COPD) Patients at the Time of COPD Diagnosis - US
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).
Measured: 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 - UK
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).
Measured: At index date of cohort entry (baseline; time of COPD diagnosis).
Charlson Comorbidity Index (CCI) at the 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.
Measured: At index date of cohort entry (baseline; time of COPD diagnosis).
Age of Patients Receiving First Maintenance Treatment - US
Age of chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United States (US) IBM MarketScan database was reported.
Measured: At index date of the first maintenance treatment
Charlson Comorbidity Index (CCI) of Patients Receiving First Maintenance Treatment - US
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.
Measured: At index date of the first maintenance treatment
Characteristics of Patients Receiving First Maintenance Treatment - US
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.
Measured: At index date of the first maintenance treatment
Age of Patients Receiving First Maintenance Treatment - UK
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.
Measured: At index date of the first maintenance treatment
Characteristics of Patients Receiving First Maintenance Treatment - UK
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.
Measured: At index date of the first maintenance treatment
Age of Patients Receiving Second Maintenance Treatment - US
Age of patients receiving second maintenance treatment from the United States (US) IBM MarketScan database was reported.
Measured: At index date of the second maintenance treatment
Charlson Comorbidity Index (CCI) of Patients Receiving Second Maintenance Treatment - US
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.
Measured: At index date of the second maintenance treatment
Characteristics of Patients Receiving Second Maintenance Treatment - US
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.
Measured: At index date of the second maintenance treatment
Age of Patients Receiving Second Maintenance Treatment - UK
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.
Measured: At index date of the second maintenance treatment
Characteristics of Patients Receiving Second Maintenance Treatment - UK
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.
Measured: At index date of the second maintenance treatment

Secondary outcomes (8)

Number of Participants With Zero Exacerbations in the Year Prior to the Start of First Maintenance Therapy - US
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.
Measured: 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 - UK
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.
Measured: At index date of the first maintenance treatment
Number of Participants With Zero Exacerbations in the Year Prior to the Start of Second Maintenance Therapy - US
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.
Measured: 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 - UK
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.
Measured: At index date of the second maintenance treatment
Days Between Index and Initiation of First Maintenance Therapy - US
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.
Measured: 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 - UK
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.
Measured: From index date until initiation of first maintenance therapy, up to 9795 days before this study started.
Days Between First and Second Maintenance Therapy - US
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.
Measured: 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 - UK
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.
Measured: From the index date of first maintenance initiation until the initiation of the second maintenance therapy, up to 10133 days before this study started.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 201914 Apr 2020

First posted15 Jun 2021
Study start15 Nov 2019
Primary completion14 Apr 2020
Study completion14 Apr 2020

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: 1,371,146 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04926233
Sponsor's protocol ID: 1237-0091
Status last verified: Nov 2021
First submitted: 13 Jun 2021
Last updated: 15 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: Yes
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, 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). For more details refer to: https://www.mystudywindow.com/msw/datasharing

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04926233
Acronym / sponsor ID: 1237-0091
Conditions: Pulmonary Disease, Chronic Obstructive
Study type: Observational
Recruitment status: Completed
Enrolment: 1,371,146 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 15 Nov 2019 (actual)
Primary completion: 14 Apr 2020 (actual)
Study completion: 14 Apr 2020 (actual)
First posted: 15 Jun 2021 (actual)
Results: Posted 20 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
COPD patients from US IBM Marketscan database	–	Drug: Tiotropium bromide + Olodaterol, Device: Sp(t)iolto® Respimat®
COPD patients from UK CPRD GOLD database	–	Drug: Tiotropium bromide + Olodaterol, Device: Sp(t)iolto® Respimat®

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tiotropium bromide + OlodaterolAlso: Sp(t)iolto® Respimat®Tiotropium bromide + Olodaterol	Drug	COPD patients from UK CPRD GOLD database, COPD patients from US IBM Marketscan database
Sp(t)iolto® Respimat®Sp(t)iolto® Respimat®	Device	COPD patients from UK CPRD GOLD database, COPD patients from US IBM Marketscan database

Primary outcome

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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

8 secondary outcomes

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 - 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 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 - UK
Time frame: At index date of the second maintenance treatment
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 - UK
Time frame: From index date until initiation of first maintenance therapy, up to 9795 days before this study started.
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 - 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.

Results and safety

Results posted to the registry on 20 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
US IBM Marketscan - Overall	1,280,486	1,280,486
UK CPRD GOLD - Overall	90,660	90,660

Primary outcome: 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).. Mean (Standard Deviation). Unit: Years

Measure	US IBM Marketscan - COPD Diagnosis Before Tio+Olo Approval n = 1021963	US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval n = 258523
Value	65.6 (13.3)	64.4 (12.8)

Primary outcome: 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).. Mean (Standard Deviation). Unit: Years

Measure	UK CPRD GOLD - COPD Diagnosis Before Tio+Olo Approval n = 79412	UK CPRD GOLD - COPD Diagnosis After Tio+Olo Approval n = 11248
Value	65.82 (13.81)	66.17 (11.17)

Population analysed: All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).

Primary outcome: Charlson Comorbidity Index (CCI) at the Time of COPD Diagnosis

Time frame: At index date of cohort entry (baseline; time of COPD diagnosis).. Mean (Standard Deviation). Unit: Score on a scale

Measure	US IBM Marketscan - Overall n = 1280486	US IBM Marketscan - COPD Diagnosis Before Tio+Olo Approval n = 1021963	US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval n = 258523	UK CPRD GOLD - Overall n = 90660	UK CPRD GOLD - COPD Diagnosis Before Tio+Olo Approval n = 79412	UK CPRD GOLD - COPD Diagnosis After Tio+Olo Approval n = 11248
Value	1.6 (1.9)	1.5 (1.9)	1.9 (2.1)	1.89 (1.38)	1.83 (1.32)	2.31 (1.66)

Population analysed: All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan (contained data collected from January 1, 2008 to March 31, 2018) and the United Kingdom (UK) CPRD GOLD databases (contained data collected from November 21, 1987 to June 30, 2018). Results were reported by overall and by stratified groups according to Tiotropium + Olodaterol approval date for US and UK datasets, respectively.

Primary outcome: Age of Patients Receiving First Maintenance Treatment - US

Time frame: At index date of the first maintenance treatment. Mean (Inter-Quartile Range). Unit: Years

Measure	US IBM Marketscan - 1MT - Overall n = 53473	US IBM Marketscan - 1MT - ICS n = 6737	US IBM Marketscan - 1MT - LABA n = 351	US IBM Marketscan - 1MT - LABA+ICS n = 26378	US IBM Marketscan - 1MT - LAMA+LABA n = 6745	US IBM Marketscan - 1MT - LAMA+LABA+ICS n = 2237	US IBM Marketscan - 1MT - LAMA n = 10892	US IBM Marketscan - 1MT - LAMA+ICS n = 133
Value	63.0 (57.0 to 73.0)	62.0 (56.0 to 73.0)	67.0 (59.0 to 79.0)	62.0 (56.0 to 72.0)	62.0 (56.0 to 72.0)	63.0 (58.0 to 74.0)	64.0 (58.0 to 75.0)	65.0 (58.0 to 76.0)

Population analysed: All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018) initiated their first maintenance therapy at the time of or after the launch date of Sp(t)iolto (referred to as Tiotropium + Olodaterol; 21 May 2015), and were free from asthma. Results were reported by overall and by stratified groups according to therapies.

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
US IBM Marketscan - Overall	0 of 0	0 of 0	0
UK CPRD GOLD - Overall	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
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, 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). For more details refer to: https://www.mystudywindow.com/msw/datasharing

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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 United States.

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 5 inclusion and 5 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 15 Nov 2021. 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 United States. 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 20 Jul 2021). 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?

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).). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04926233.

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 15 Nov 2021.