Pulmonary Disease, Chronic ObstructiveNCT04184297
Comparative Effectiveness and Safety of Tiotropium and Olodaterol in Comparison to Triple Therapy
An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 1 site in United States.
Trial summary
To assess the comparative effectiveness of combination Tiotropium and Olodaterol (Tio+Olo) (FDC) compared to combination LAMA/LABA and ICS (fixed or open), and to explore whether this varies across COPD sub populations defined by exacerbation risk 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 and Olodaterol (Tio+Olo) and Long-acting beta2-agonist and Inhaled corticosteroids (LABA and ICS)
- How many people
- 27,190 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 4 Nov 2019
- 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: Subjects with COPD inititated with Tio+Olo in comparison to patients treated with ICS/LABA/LAMA
Who may be able to join
- New users of Tio+Olo on the same date or of LABA, LAMA and ICS, either as a fixed-dose combination (LABA/LAMA/ICS) or free combination (LABA/ICS + LAMA, etc), on the same date between January 2013 and March 2019.
- Diagnosis of COPD prior to first maintenance inhaler and age ≥ 40 years at index date
Who cannot join
- Less than one year of medical history information prior to the date of combined treatment initiation (index date)
- Lung cancer, interstitial lung disease, or lung transplantation at any time prior to the index date
- Asthma diagnosis within one year prior to the index date
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Safety of Maintenance Treatment With Combination of Tiotropium and Olodaterol in Comparison to Maintenance Treatment With a Combination of Inhaled Corticosteroids, Long-acting β2 Agonists and Long-acting Muscarinic Antagonists in COPD Patients
To assess the comparative effectiveness of combination Tiotropium and Olodaterol (Tio+Olo) (FDC) compared to combination LAMA/LABA and ICS (fixed or open), and to explore whether this varies across COPD sub populations defined by exacerbation risk
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Tiotropium and Olodaterol (Tio+Olo), Long-acting beta2-agonist and Inhaled corticosteroids (LABA and ICS)
- 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 and Olodaterol (Tio+Olo)Drug
drug
Long-acting beta2-agonist and Inhaled corticosteroids (LABA and ICS)Drug
drug
| Study group | Role | What they receive |
|---|---|---|
| Subjects initiated with Tiotropium and Olodaterol (Tio+Olo) | Not described Receives: Drug: Tiotropium and Olodaterol (Tio+Olo) | |
| Subjets initiated with LABA/LAMA/ICS | Long-acting beta2/ Long-acting muscarinic antagonists/Inhaled corticosteriods Receives: Drug: Long-acting beta2-agonist and Inhaled corticosteroids (LABA and ICS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation was reported. Time to the first Chronic obstructive pulmonary disease (COPD) exacerbation will be measured from cohort entry until the occurrence of a hospitalization for COPD (severe exacerbation) or Emergency Department (ED) visit for COPD with the prescription of an antibiotic and/or an oral corticosteroid on the same day (moderate exacerbation).
Measured: From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to 1 year after cohort entry.
Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation - Without Exacerbation Within 30 Days Prior to Cohort Entry
Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation excluding participants who had exacerbation within 30 days prior to cohort entry, was reported. Time to the first Chronic obstructive pulmonary disease (COPD) exacerbation will be measured from cohort entry until the occurrenceof a hospitalization for COPD (severe exacerbation) or Emergency Department (ED) visit for COPD with the prescription of an antibiotic and/or an oral corticosteroid on the same day (moderate exacerbation).
Measured: From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to 1 year after cohort entry.
Secondary outcomes (1)
Overall Incidence Rate of Hospitalization for Community-acquired Pneumonia (Serious Pneumonia)
Overall incidence rate of first hospitalization for community-acquired pneumonia (serious pneumonia).
Measured: From cohort entry (index date) until the occurrence of hospitalization for community-acquired pneumonia (serious pneumonia). Up to 1 year after cohort entry.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start1 Nov 2019
- Primary completion4 Nov 2019
- Study completion4 Nov 2019
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
- 27,190 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
- NCT04184297
- Sponsor's protocol ID
- 1237-0094
- Status last verified
- Nov 2021
- First submitted
- 28 Nov 2019
- Last updated
- 15 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- 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, 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
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
- Effectiveness and Safety of Maintenance Treatment With Combination of Tiotropium and Olodaterol in Comparison to Maintenance Treatment With a Combination of Inhaled Corticosteroids, Long-acting β2 Agonists and Long-acting Muscarinic Antagonists in COPD Patients
- ClinicalTrials.gov ID
- NCT04184297
- Acronym / sponsor ID
- 1237-0094
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27,190 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 4 Nov 2019 (actual)
- Study completion
- 4 Nov 2019 (actual)
- First posted
- 3 Dec 2019 (actual)
- Results
- Posted 30 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the comparative effectiveness of combination Tiotropium and Olodaterol (Tio+Olo) (FDC) compared to combination LAMA/LABA and ICS (fixed or open), and to explore whether this varies across COPD sub populations defined by exacerbation risk
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects initiated with Tiotropium and Olodaterol (Tio+Olo) | – | Drug: Tiotropium and Olodaterol (Tio+Olo) |
| Subjets initiated with LABA/LAMA/ICS | – | Drug: Long-acting beta2-agonist and Inhaled corticosteroids (LABA and ICS)Long-acting beta2/ Long-acting muscarinic antagonists/Inhaled corticosteriods |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with COPD inititated with Tio+Olo in comparison to patients treated with ICS/LABA/LAMA
Key inclusion criteria (2 listed)
- New users of Tio+Olo on the same date or of LABA, LAMA and ICS, either as a fixed-dose combination (LABA/LAMA/ICS) or free combination (LABA/ICS + LAMA, etc), on the same date between January 2013 and March 2019.
- Diagnosis of COPD prior to first maintenance inhaler and age ≥ 40 years at index date
Key exclusion criteria (3 listed)
- Less than one year of medical history information prior to the date of combined treatment initiation (index date)
- Lung cancer, interstitial lung disease, or lung transplantation at any time prior to the index date
- Asthma diagnosis within one year prior to the index date
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 and Olodaterol (Tio+Olo)drug | Drug | Subjects initiated with Tiotropium and Olodaterol (Tio+Olo) |
| Long-acting beta2-agonist and Inhaled corticosteroids (LABA and ICS)drug | Drug | Subjets initiated with LABA/LAMA/ICS |
Primary outcome
Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Time frame: From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to 1 year after cohort entry.
Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation was reported. Time to the first Chronic obstructive pulmonary disease (COPD) exacerbation will be measured from cohort entry until the occurrence of a hospitalization for COPD (severe exacerbation) or Emergency Department (ED) visit for COPD with the prescription of an antibiotic and/or an oral corticosteroid on the same day (moderate exacerbation).
Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation - Without Exacerbation Within 30 Days Prior to Cohort Entry
Time frame: From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to 1 year after cohort entry.
Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation excluding participants who had exacerbation within 30 days prior to cohort entry, was reported. Time to the first Chronic obstructive pulmonary disease (COPD) exacerbation will be measured from cohort entry until the occurrenceof a hospitalization for COPD (severe exacerbation) or Emergency Department (ED) visit for COPD with the prescription of an antibiotic and/or an oral corticosteroid on the same day (moderate exacerbation).
1 secondary outcome
Overall Incidence Rate of Hospitalization for Community-acquired Pneumonia (Serious Pneumonia)
Time frame: From cohort entry (index date) until the occurrence of hospitalization for community-acquired pneumonia (serious pneumonia). Up to 1 year after cohort entry.
Results and safety
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 2 inclusion and 3 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 30 Nov 2020). 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?
Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation (time frame: From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to 1 year after cohort entry.). The study lists 2 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 15 Nov 2021.