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| Name | Class |
|---|---|
| Carelon Research | OTHER |
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The primary objective of this pragmatic study is to compare the time to first moderate or severe COPD exacerbation in patients, not controlled on their current therapy, randomized to Stiolto Respimat versus triple therapy over 12 months of treatment
The secondary objectives of this study include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stiolto Respimat | Experimental |
| |
| ICS plus LABA plus LAMA (triple therapy) | Active Comparator | ICS (Inhaled Corticosteroid) plus LABA (Long-Acting Beta Agonist) plus (Long-Acting Muscarinic Antagonist) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stiolto Respimat | Drug | Duration - 12 months |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over the 12 Month Study Period | Time to first moderate or severe chronic obstructive (COPD) exacerbation over 12 months of treatment pulmonary disease. Moderate exacerbation was a patient receiving an exacerbation-related prescription such as oral corticosteroid (prednisone or prednisolone) and/or antibiotic, but not requiring hospitalization. Severe exacerbation was a patient requiring hospitalization or emergency room visit due to COPD (ICD-9-491.21 or ICD-10-J44.1). Median survival time as well as 95% confidence interval was calculated using Kaplan-Meier curves. | Baseline till end of study, up to 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Annual Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | Annual rate of moderate or severe chronic obstructive pulmonary disease (COPD) exacerbations. Moderate exacerbation was a patient receiving an exacerbation-related prescription such as oral corticosteroid (prednisone or prednisolone) and/or antibiotic, but not requiring hospitalization. Severe exacerbation was a patient requiring hospitalization or emergency room visit due to COPD (ICD-9-491.21 or ICD-10-J44.1). Annual rate analysis utilized a negative binomial model with fixed effect of treatment (Stiolto Respimat versus triple therapy), logarithm of observational time as offset, and baseline prior ICS was used as a covariate. |
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Inclusion Criteria:
COPD diagnosis as defined by the study physician
Currently on one of the following maintenance therapies:
Physician determination that patient is not controlled on current pharmacotherapy
Adult patient 40 years of age or older at time of study enrollment
Willingness and ability to understand and provide documented Informed Consent Form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form prior to commencement of any study required assessments, either directly or through Legally Authorized Representative.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Associates of Mobile, PC | Mobile | Alabama | 36608 | United States | ||
| Healthscan Clinical Trials LLC |
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| Label | URL |
|---|---|
| Related Info | View source |
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Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
This was a pragmatic randomized open label active controlled parallel group design trial conducted in a real-world, community-based practice setting. Participants were on long-acting muscarinic antagonist (LAMA), long-acting beta agonist (LABA) or Inhaled Corticosteroid (ICS)/LABA for COPD, but were determined by their physician to not be controlled on their current therapy. Subjects were randomized to either Stiolto Respimat or ICS plus LABA plus LAMA (triple therapy) for the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Stiolto® Respimat® | Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician. Patients started the following Stiolto® Respimat® treatment: Fixed dose of 2.5 micrograms (mcg) tiotropium and 2.5 mcg olodaterol (Stiolto® Respimat®) per actuation were inhaled twice daily (tiotropium/olodaterol daily dosage: 5/5 mcg). Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 9, 2018 | Sep 9, 2021 |
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| ICS (Inhaled Corticosteroid) (Triple therapy) | Drug | Duration - 12 months |
|
| LABA (Long-Acting Beta Agonist) (Triple therapy) | Drug | Duration - 12 months |
|
| LAMA (Long-Acting Muscarinic Antagonist) (Triple therapy) | Drug | Duration - 12 months |
|
| Baseline till end of study, up to 12 months. |
| Time to First Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over 12 Months of Treatment Pulmonary Disease | Time to first severe chronic obstructive (COPD) exacerbation over 12 months of treatment pulmonary disease. Moderate exacerbation was a patient receiving an exacerbation-related prescription such as oral corticosteroid (prednisone or prednisolone) and/or antibiotic, but not requiring hospitalization. Severe exacerbation was a patient requiring hospitalization or emergency room visit due to COPD (ICD-9-491.21 or ICD-10-J44.1). Median survival time as well as 95% confidence interval was calculated using Kaplan-Meier curves. | Baseline till end of study, up to 12 months. |
| Annual Rate of Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | Annual rate of severe chronic obstructive pulmonary disease (COPD) exacerbations. Severe exacerbation was a patient requiring hospitalization or emergency room visit due to COPD (ICD-9-491.21 or ICD-10-J44.1). Annual rate analysis utilized a negative binomial model with fixed effect of treatment (Stiolto Respimat versus triple therapy), logarithm of observational time as offset, and baseline prior ICS was used as a covariate. | Baseline till end of study, up to 12 months. |
| Number of Patients With Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Over the 12 Month Observation Period | Number of patients with moderate or severe chronic obstructive pulmonary disease (COPD) exacerbations over the 12 month observation period. Moderate exacerbation was a patient receiving an exacerbation-related prescription such as oral corticosteroid (prednisone or prednisolone) and/or antibiotic, but not requiring hospitalization. Severe exacerbation was a patient requiring hospitalization or emergency room visit due to COPD (ICD-9-491.21 or ICD-10-J44.1). | 12 months after baseline. |
| Montgomery |
| Alabama |
| 36106 |
| United States |
| HealthScan Research | Montgomery | Alabama | 36109 | United States |
| Diamond Childrens Medical Center | Tucson | Arizona | 85724 | United States |
| CareMore Apple Valley Care Center | Apple Valley | California | 92308 | United States |
| HealthCare Partners | Commerce | California | 90040 | United States |
| Advanced Research Center, Inc. | Murrieta | California | 92562 | United States |
| Newport Native MD, Inc | Newport Beach | California | 92663 | United States |
| Aureus Medical Group, Inc | Rancho Cucamonga | California | 91730 | United States |
| Capital Allergy and Respiratory Disease Center | Roseville | California | 95661 | United States |
| Paloma Medical Group | San Juan Capistrano | California | 92675 | United States |
| Adnab Research/Prestige Care Physician | Torrance | California | 90505 | United States |
| Pulmonary and Sleep of Tampa Bay | Brandon | Florida | 33511 | United States |
| Innovative Research of West Florida, Inc. | Clearwater | Florida | 33756 | United States |
| Saint Francis Sleep, Allergy and Lung Institute, LLC | Clearwater | Florida | 33765 | United States |
| Cohen Medical Research Associates, LLC | Delray Beach | Florida | 33446 | United States |
| Gary J. Richmond, M.D., PA | Fort Lauderdale | Florida | 33316 | United States |
| Medical Research of Central Florida | Leesburg | Florida | 34748 | United States |
| Florida Lung and Sleep Associates | Lehigh Acres | Florida | 33971 | United States |
| TRY Research | Maitland | Florida | 32751 | United States |
| Pro Live Medical Research | Miami | Florida | 33175 | United States |
| Advanced Research for Health Improvement, LLC | Naples | Florida | 34102 | United States |
| Oviedo Medical Research | Oviedo | Florida | 32765 | United States |
| Bassetti Medical Research Inc | Sebring | Florida | 33870 | United States |
| Pasadena Ctr for Medical Rsrch | St. Petersburg | Florida | 33707 | United States |
| John Suen MD PA | Vero Beach | Florida | 32960 | United States |
| Gwinnett Research Institute | Buford | Georgia | 30519 | United States |
| Pulmonary and Sleep Specialists, PC | Decatur | Georgia | 30033 | United States |
| DC Pulmonary Medicine | Marietta | Georgia | 30060 | United States |
| Southern IL Clinical Rsrch Ctr | O'Fallon | Illinois | 62269 | United States |
| American Health Network of Indiana, LLC | Franklin | Indiana | 46131 | United States |
| American Health Network of Indiana, LLC | Greenfield | Indiana | 46140 | United States |
| The LaPorte County Institute for Clinical Research | Michigan City | Indiana | 46360 | United States |
| Ball Memorial Hospital | Muncie | Indiana | 47303 | United States |
| American Health Network | New Albany | Indiana | 47150 | United States |
| Kentucky Lung Clinic | Georgetown | Kentucky | 40324 | United States |
| Pulmonary and Sleep Clinic PLLV | Hopkinsville | Kentucky | 42240 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21224 | United States |
| Pulmonary and Critical Care Associates of Baltimore | Bel Air | Maryland | 21014 | United States |
| Pulmonary and Critical Care Associates of Baltimore | Towson | Maryland | 21286 | United States |
| Lahey Hospital and Medical Center | Burlington | Massachusetts | 01805 | United States |
| Vida Clinical Studies | Dearborn | Michigan | 48124 | United States |
| Flint Clinical Research | Flint | Michigan | 48503 | United States |
| Mercy Surgery Center | Springfield | Missouri | 65804 | United States |
| Clayton Sleep Institute | St Louis | Missouri | 63123 | United States |
| Jubilee Clinical Research, Inc | Las Vegas | Nevada | 89106 | United States |
| Shore Pulmonary, PA | Ocean City | New Jersey | 07712 | United States |
| Bassett Medical Center | Cooperstown | New York | 13326 | United States |
| Pulmonary Health Physicians | Fayetteville | New York | 13066 | United States |
| Feinstein Institute for Medical Research | New Hyde Park | New York | 11040 | United States |
| Lenox Hill Hospital | New York | New York | 10021 | United States |
| Orchard Park Family Practice | Orchard Park | New York | 14127 | United States |
| American Health Research, Inc. | Charlotte | North Carolina | 28207 | United States |
| Clinical Research of Gastonia | Gastonia | North Carolina | 28054 | United States |
| Coastal Carolina Health Care, P.A. | New Bern | North Carolina | 28562 | United States |
| Tabor City Family Medicine | Tabor City | North Carolina | 28463 | United States |
| Goshen Medical Center | Whiteville | North Carolina | 28472 | United States |
| Southeastern Research Center | Winston-Salem | North Carolina | 27103 | United States |
| Catherine LaRuffa, MD, Inc. | Blanchester | Ohio | 45107 | United States |
| Valley Medical Primary Care | Centerville | Ohio | 45459 | United States |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States |
| Midwest Pulmonary and Sleep Research | Dayton | Ohio | 45459 | United States |
| Ohio Sleep and Pulmonary Center | Englewood | Ohio | 45322 | United States |
| Prestige Clinical Research | Franklin | Ohio | 45005 | United States |
| Robert Santiago MD, Inc. | Galion | Ohio | 44833 | United States |
| Pulmonary, Critical Care and Sleep Medicine Associates | Hamilton | Ohio | 45013 | United States |
| Wells Inst for Hlth Awareness | Kettering | Ohio | 45429 | United States |
| Pulmonary Medicine | South Euclid | Ohio | 44121 | United States |
| Toledo Clinic Incorporated | Toledo | Ohio | 43623 | United States |
| Ohio Clinical Research, LLC | Willoughby Hills | Ohio | 44094 | United States |
| Comprehensive Internal Medicine, Inc. | Wooster | Ohio | 44691 | United States |
| Preferred Primary Care Phys | Pittsburgh | Pennsylvania | 15236 | United States |
| Preferred Primary Care Phys | Pittsburgh | Pennsylvania | 15243 | United States |
| Frontier Clinical Research, LLC | Scottdale | Pennsylvania | 15683 | United States |
| Frontier Clinical Research LLC | Smithfield | Pennsylvania | 15478 | United States |
| Preferred Primary Care Phys | Uniontown | Pennsylvania | 15401 | United States |
| Carolina Medical Research | Clinton | South Carolina | 29325 | United States |
| Main Street Physicians Care | Little River | South Carolina | 29566 | United States |
| Family Medicine of SayeBrook | Myrtle Beach | South Carolina | 29588 | United States |
| Houston Pulmonary Sleep Allergy and Asthma Associates | Cypress | Texas | 77429 | United States |
| Texas Health Physicians Group | Dallas | Texas | 75243 | United States |
| North Texas Lung & Sleep Clnc | Fort Worth | Texas | 76109 | United States |
| SMS Clinical Research | Mesquite | Texas | 75149 | United States |
| San Marcos Family Medicine | San Marcos | Texas | 78666 | United States |
| Texarkana Clinical Research | Texarkana | Texas | 75503 | United States |
| Chesapeake Pulmonary and Critical Care | Chesapeake | Virginia | 23320 | United States |
| Richmond Family Practice | Richmond | Virginia | 23220 | United States |
| MultiCare Institute | Cheney | Washington | 99004 | United States |
| Western Washington Medical Grp | Everett | Washington | 98208 | United States |
| Pulmonary and Critical Care Associates, SC | Cudahy | Wisconsin | 53110 | United States |
| FG001 | ICS Plus LABA Plus LAMA (Triple Therapy) | Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician. Patients started the following ICS plus LABA plus LAMA (triple therapy) treatment made up of the combination of any approved drugs that their physician chooses.Triple Therapy (ICS + LABA + LAMA) was inhaled with dose as prescribed by physicians per label for selected medications. Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment. |
| COMPLETED | 12 Month Study Observation Period |
|
| NOT COMPLETED |
|
|
Intent to Treat (ITT) Population: The ITT population will include all randomized patients allocated to their original randomized treatment group, even if they switched or discontinued study treatment. Due to investigator error, 5 patients in each group received the prescription for the wrong treatment. These subjects were included in the actual treatment, not the randomized treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Stiolto® Respimat® | Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician. Patients started the following Stiolto® Respimat® treatment: Fixed dose of 2.5 micrograms (mcg) tiotropium and 2.5 mcg olodaterol (Stiolto® Respimat®) per actuation were inhaled twice daily (tiotropium/olodaterol daily dosage: 5/5 mcg). Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment. |
| BG001 | ICS Plus LABA Plus LAMA (Triple Therapy) | Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician. Patients started the following ICS plus LABA plus LAMA (triple therapy) treatment made up of the combination of any approved drugs that their physician chooses.Triple Therapy (ICS + LABA + LAMA) was inhaled with dose as prescribed by physicians per label for selected medications. Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over the 12 Month Study Period | Time to first moderate or severe chronic obstructive (COPD) exacerbation over 12 months of treatment pulmonary disease. Moderate exacerbation was a patient receiving an exacerbation-related prescription such as oral corticosteroid (prednisone or prednisolone) and/or antibiotic, but not requiring hospitalization. Severe exacerbation was a patient requiring hospitalization or emergency room visit due to COPD (ICD-9-491.21 or ICD-10-J44.1). Median survival time as well as 95% confidence interval was calculated using Kaplan-Meier curves. | Intent to Treat (ITT) Population: The ITT population will include all randomized patients allocated to their original randomized treatment group, even if they switched or discontinued study treatment. Only patients with non missing ICS baseline values were included. Due to investigator error, 5 patients in each group received the prescription for the wrong treatment. These subjects were included in the actual treatment, not the randomized treatment. | Posted | Median | 95% Confidence Interval | Months | Baseline till end of study, up to 12 months. |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Annual Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | Annual rate of moderate or severe chronic obstructive pulmonary disease (COPD) exacerbations. Moderate exacerbation was a patient receiving an exacerbation-related prescription such as oral corticosteroid (prednisone or prednisolone) and/or antibiotic, but not requiring hospitalization. Severe exacerbation was a patient requiring hospitalization or emergency room visit due to COPD (ICD-9-491.21 or ICD-10-J44.1). Annual rate analysis utilized a negative binomial model with fixed effect of treatment (Stiolto Respimat versus triple therapy), logarithm of observational time as offset, and baseline prior ICS was used as a covariate. | Intent to Treat (ITT) Population: The ITT population will include all randomized patients allocated to their original randomized treatment group, even if they switched or discontinued study treatment. Only patients with non missing ICS baseline values were included. Due to investigator error, 5 patients in each group received the prescription for the wrong treatment. These subjects were included in the actual treatment, not the randomized treatment. | Posted | Mean | 95% Confidence Interval | Exacerbations per participant per year | Baseline till end of study, up to 12 months. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over 12 Months of Treatment Pulmonary Disease | Time to first severe chronic obstructive (COPD) exacerbation over 12 months of treatment pulmonary disease. Moderate exacerbation was a patient receiving an exacerbation-related prescription such as oral corticosteroid (prednisone or prednisolone) and/or antibiotic, but not requiring hospitalization. Severe exacerbation was a patient requiring hospitalization or emergency room visit due to COPD (ICD-9-491.21 or ICD-10-J44.1). Median survival time as well as 95% confidence interval was calculated using Kaplan-Meier curves. | Intent to Treat (ITT) Population: The ITT population will include all randomized patients allocated to their original randomized treatment group, even if they switched or discontinued study treatment. Only patients with non missing ICS baseline values were included. Due to investigator error, 5 patients in each group received the prescription for the wrong treatment. These subjects were included in the actual treatment, not the randomized treatment. | Posted | Median | 95% Confidence Interval | Months | Baseline till end of study, up to 12 months. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Annual Rate of Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | Annual rate of severe chronic obstructive pulmonary disease (COPD) exacerbations. Severe exacerbation was a patient requiring hospitalization or emergency room visit due to COPD (ICD-9-491.21 or ICD-10-J44.1). Annual rate analysis utilized a negative binomial model with fixed effect of treatment (Stiolto Respimat versus triple therapy), logarithm of observational time as offset, and baseline prior ICS was used as a covariate. | Intent to Treat (ITT) Population: The ITT population will include all randomized patients allocated to their original randomized treatment group, even if they switched or discontinued study treatment. Only patients with non missing ICS baseline values were included. Due to investigator error, 5 patients in each group received the prescription for the wrong treatment. These subjects were included in the actual treatment, not the randomized treatment. | Posted | Mean | 95% Confidence Interval | Exacerbations per participant per year | Baseline till end of study, up to 12 months. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Over the 12 Month Observation Period | Number of patients with moderate or severe chronic obstructive pulmonary disease (COPD) exacerbations over the 12 month observation period. Moderate exacerbation was a patient receiving an exacerbation-related prescription such as oral corticosteroid (prednisone or prednisolone) and/or antibiotic, but not requiring hospitalization. Severe exacerbation was a patient requiring hospitalization or emergency room visit due to COPD (ICD-9-491.21 or ICD-10-J44.1). | Intent to Treat (ITT) Population: The ITT population will include all randomized patients allocated to their original randomized treatment group, even if they switched or discontinued study treatment. Only patients with non missing ICS baseline values were included. Due to investigator error, 5 patients in each group received the prescription for the wrong treatment. These subjects were included in the actual treatment, not the randomized treatment. | Posted | Count of Participants | Participants | 12 months after baseline. |
|
Up to 12 months + 21 days.
All-Cause Mortality: all randomized patients allocated to original randomized treatment group. 5 patients in each group received the wrong prescription, these were included in the actual treatment.
Adverse events (AE): all randomized patients who received a prescription of any study treatment.
Non-serious AE collection and reporting was limited to events leading to trial discontinuation, treatment discontinuation or death as this is an approved product with a known safety profile.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stiolto® Respimat® | Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician. Patients started the following Stiolto® Respimat® treatment: Fixed dose of 2.5 micrograms (mcg) tiotropium and 2.5 mcg olodaterol (Stiolto® Respimat®) per actuation were inhaled twice daily (tiotropium/olodaterol daily dosage: 5/5 mcg). Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment. | 12 | 356 | 56 | 325 | 0 | 325 |
| EG001 | ICS Plus LABA Plus LAMA (Triple Therapy) | Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician. Patients started the following ICS plus LABA plus LAMA (triple therapy) treatment made up of the combination of any approved drugs that their physician chooses.Triple Therapy (ICS + LABA + LAMA) was inhaled with dose as prescribed by physicians per label for selected medications. Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment. | 12 | 358 | 45 | 318 | 0 | 318 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute left ventricular failure | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia mycoplasmal | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Urinary tract infection viral | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Blood osmolarity decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Lung carcinoma cell type unspecified stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Toxic encephalopathy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| End stage renal disease | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Renal disorder | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Transcatheter aortic valve implantation | Surgical and medical procedures | MedDRA 23.1 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Essential hypertension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
Not provided
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 16, 2021 | Sep 9, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000611386 | tiotropium-olodaterol |
| C084098 | laminin A |
Not provided
Not provided
Not provided
| Female |
|
| Missing |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| American Indian or Alaska Native |
|
| Other |
|
| Missing |
|
| OG001 | Triple Therapy | Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician. Patients were switched to a treatment of ICS plus LABA plus LAMA (triple therapy), made up of the combination of any approved drugs that their physician chooses, for 12 months of treatment. |
|
|
|
| OG001 | ICS Plus LABA Plus LAMA (Triple Therapy) | Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician. Patients started the following ICS plus LABA plus LAMA (triple therapy) treatment made up of the combination of any approved drugs that their physician chooses.Triple Therapy (ICS + LABA + LAMA) was inhaled with dose as prescribed by physicians per label for selected medications. Patients were followed for 12 months regardless of treatment switching or discontinuing study treatment. |
|
|
|
| OG001 | Triple Therapy | Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician. Patients were switched to a treatment of ICS plus LABA plus LAMA (triple therapy), made up of the combination of any approved drugs that their physician chooses, for 12 months of treatment. |
|
|
|
| OG001 | Triple Therapy | Patients with chronic obstructive pulmonary disease (COPD) who were on long-acting muscarinic antagonist (LAMA) or long-acting beta agonist (LABA) or inhaled corticosteroid (ICS)/LABA maintenance therapy, and whose treatment was not controlled on the medication regimen as determined by the physician. Patients were switched to a treatment of ICS plus LABA plus LAMA (triple therapy), made up of the combination of any approved drugs that their physician chooses, for 12 months of treatment. |
|
|
|