Trial · NCT04926233
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
NCT04926233, Completed, Boehringer Ingelheim; results first posted 2021-07-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT04926233. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04926233
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- NCT number
- NCT04926233
- Status
- Completed
- Enrollment
- 1,371,146 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Tiotropium bromide + Olodaterol, Sp(t)iolto® Respimat®
- First posted
- 2021-06-15
- Last updated
- 2021-11-15
- Results first posted
- 2021-07-20
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Age of the Chronic Obstructive Pulmonary Disease (COPD) Patients at the Time of COPD Diagnosis - US | 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). |
| Primary | Age of the Chronic Obstructive Pulmonary Disease (COPD) Patients at the Time of COPD Diagnosis - UK | 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). |
| Primary | Charlson Comorbidity Index (CCI) at the Time of COPD Diagnosis | 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. |
| Primary | Age of Patients Receiving First Maintenance Treatment - US | 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. |
| Primary | Charlson Comorbidity Index (CCI) of Patients Receiving First Maintenance Treatment - US | 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. |
| Primary | Characteristics of Patients Receiving First Maintenance Treatment - US | 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. |
| Primary | Age of Patients Receiving First Maintenance Treatment - UK | 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. |
| Primary | Characteristics of Patients Receiving First Maintenance Treatment - UK | 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. |
| Primary | Age of Patients Receiving Second Maintenance Treatment - US | 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. |
| Primary | Charlson Comorbidity Index (CCI) of Patients Receiving Second Maintenance Treatment - US | 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. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Age of the Chronic Obstructive Pulmonary Disease (COPD) Patients at the Time of COPD Diagnosis - US | At index date of cohort entry (baseline; time of COPD diagnosis). | 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). | Years | MEAN |
| PRIMARY | Age of the Chronic Obstructive Pulmonary Disease (COPD) Patients at the Time of COPD Diagnosis - UK | At index date of cohort entry (baseline; time of COPD diagnosis). | 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). | Years | MEAN |
| PRIMARY | Charlson Comorbidity Index (CCI) at the Time of COPD Diagnosis | At index date of cohort entry (baseline; time of COPD diagnosis). | 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. | Score on a scale | MEAN |
| PRIMARY | Age of Patients Receiving First Maintenance Treatment - US | At index date of the first maintenance treatment | 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. | Years | MEAN |
| PRIMARY | Charlson Comorbidity Index (CCI) of Patients Receiving First Maintenance Treatment - US | At index date of the first maintenance treatment | 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. | Score on a scale | MEAN |
| PRIMARY | Characteristics of Patients Receiving First Maintenance Treatment - US | At index date of the first maintenance treatment | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Age of Patients Receiving First Maintenance Treatment - UK | At index date of the first maintenance treatment | 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) initiated their first maintenance therapy at the time of or after the launch date of Sp(t)iolto (referred to as Tiotropium+Olodaterol; 1 July 2015), and were free from asthma. Results were reported by overall and by stratified groups according to therapies. | Years | MEDIAN |
| PRIMARY | Characteristics of Patients Receiving First Maintenance Treatment - UK | At index date of the first maintenance treatment | 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) initiated their first maintenance therapy at the time of or after the launch date of Sp(t)iolto (referred to as Tiotropium+Olodaterol; 1 July 2015), and were free from asthma. Results were reported by overall and by stratified groups according to therapies. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Age of Patients Receiving Second Maintenance Treatment - US | At index date of the second maintenance treatment | 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 second maintenance therapy and were free from asthma prior to initiation of first maintenance therapy. Results were reported by overall and by stratified groups according to therapies. | Years | MEDIAN |
| PRIMARY | Charlson Comorbidity Index (CCI) of Patients Receiving Second Maintenance Treatment - US | At index date of the second maintenance treatment | 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 second maintenance therapy and were free from asthma prior to initiation of first maintenance therapy. Results were reported by overall and by stratified groups according to therapies. | Score on a scale | MEDIAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group290
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Age of the Chronic Obstructive Pulmonary Disease (COPD) Patients at the Time of COPD Diagnosis - US | US IBM Marketscan - COPD Diagnosis Before Tio+Olo Approval | 65.6 | Standard Deviation 13.3 | Years | |
| Age of the Chronic Obstructive Pulmonary Disease (COPD) Patients at the Time of COPD Diagnosis - US | US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval | 64.4 | Standard Deviation 12.8 | Years | |
| Age of the Chronic Obstructive Pulmonary Disease (COPD) Patients at the Time of COPD Diagnosis - UK | UK CPRD GOLD - COPD Diagnosis Before Tio+Olo Approval | 65.82 | Standard Deviation 13.81 | Years | |
| Age of the Chronic Obstructive Pulmonary Disease (COPD) Patients at the Time of COPD Diagnosis - UK | UK CPRD GOLD - COPD Diagnosis After Tio+Olo Approval | 66.17 | Standard Deviation 11.17 | Years | |
| Charlson Comorbidity Index (CCI) at the Time of COPD Diagnosis | US IBM Marketscan - Overall | 1.6 | Standard Deviation 1.9 | Score on a scale | |
| Charlson Comorbidity Index (CCI) at the Time of COPD Diagnosis | US IBM Marketscan - COPD Diagnosis Before Tio+Olo Approval | 1.5 | Standard Deviation 1.9 | Score on a scale | |
| Charlson Comorbidity Index (CCI) at the Time of COPD Diagnosis | US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval | 1.9 | Standard Deviation 2.1 | Score on a scale | |
| Charlson Comorbidity Index (CCI) at the Time of COPD Diagnosis | UK CPRD GOLD - Overall | 1.89 | Standard Deviation 1.38 | Score on a scale | |
| Charlson Comorbidity Index (CCI) at the Time of COPD Diagnosis | UK CPRD GOLD - COPD Diagnosis Before Tio+Olo Approval | 1.83 | Standard Deviation 1.32 | Score on a scale | |
| Charlson Comorbidity Index (CCI) at the Time of COPD Diagnosis | UK CPRD GOLD - COPD Diagnosis After Tio+Olo Approval | 2.31 | Standard Deviation 1.66 | Score on a scale |
1 to 10 of 290Source ClinicalTrials.gov
See all 290 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | US IBM Marketscan - Overall | 1,280,486 | |
| Overall Study | STARTED | UK CPRD GOLD - Overall | 90,660 | |
| Overall Study | COMPLETED | US IBM Marketscan - Overall | 1,280,486 | |
| Overall Study | COMPLETED | UK CPRD GOLD - Overall | 90,660 | |
| Overall Study | NOT COMPLETED | US IBM Marketscan - Overall | 0 | |
| Overall Study | NOT COMPLETED | UK CPRD GOLD - Overall | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | US IBM Marketscan - Overall | 0 | 0 |
| Total, all-cause mortality | UK CPRD GOLD - Overall | 0 | 0 |
| Total, other adverse events | US IBM Marketscan - Overall | 0 | 0 |
| Total, other adverse events | UK CPRD GOLD - Overall | 0 | 0 |
| Total, serious adverse events | US IBM Marketscan - Overall | 0 | 0 |
| Total, serious adverse events | UK CPRD GOLD - Overall | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04926233
GET https://conductscience.org/api/trials/v1/NCT04926233/registered?page=2