A Phase 4 interventional study of Stiolto Respimat and ICS (Inhaled Corticosteroid) (Triple therapy) in Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim. Completed at 90 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2022-06-14.
Sponsored by Boehringer Ingelheim · Phase 4, Interventional, and Treatment
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Among 236 studies in Pulmonary Disease, Chronic Obstructive by Boehringer Ingelheim — 1 open to participants now, 1 under way, 1 of them phase 3. Pulmonary Disease, Chronic Obstructive · Boehringer Ingelheim.
Among the 236 studies in Pulmonary Disease, Chronic Obstructive by Boehringer Ingelheim, this one is the 27th largest by enrollment of the 155 interventional ones that give a count, is one of 9 that started in 2017, is one of 32 in phase 4, and was the 206th registered.
5,522 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.
Browse Pulmonary Disease, Chronic Obstructive studies →1 of the 236 studies in Pulmonary Disease, Chronic Obstructive by Boehringer Ingelheim is open now, in 3 countries. Recruiting first, the newest first:
Boehringer Ingelheim · Sites in United States, Italy, Malaysia
Ages 40+
By country, each count listing its studies:
Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 89 take healthy volunteers.
This study: 40 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
236 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 9 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 714 is above the median of 62 across 3,840 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Median enrollment 166 across the 155 interventional studies, 1,577 across the 80 observational. Of the 232 that completed or were terminated, 124 (53%) have results posted.
This tab as a report to print or save as PDF → With an account.
Boehringer Ingelheim is the lead sponsor of 2,304 studies on the registry; 61 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 123 (73%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 236 studies in Pulmonary Disease, Chronic Obstructive by Boehringer Ingelheim, from their registry updates:
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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:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Currently on one of the following maintenance therapies:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Stiolto Respimat
ICS (Inhaled Corticosteroid) plus LABA (Long-Acting Beta Agonist) plus (Long-Acting Muscarinic Antagonist)
Drug: ICS (Inhaled Corticosteroid) (Triple therapy) · Drug: LABA (Long-Acting Beta Agonist) (Triple therapy) · Drug: LAMA (Long-Acting Muscarinic Antagonist) (Triple therapy)
Duration - 12 months
Also known as: INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO
Duration - 12 months
Duration - 12 months
Duration - 12 months
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.
Time frame: Baseline till end of study, up to 12 months.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 12 months after baseline.
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.
| Milestone | Stiolto® Respimat® | ICS Plus LABA Plus LAMA (Triple Therapy) |
|---|---|---|
| Started | 356 | 358 |
| Completed | 285 | 302 |
| Not completed | 71 | 56 |
| Withdrew: Protocol violation | 2 | 0 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Withdrawal by subject | 23 | 19 |
| Withdrew: Death | 12 | 12 |
| Withdrew: Lost to follow-up | 13 | 9 |
| Withdrew: Missing end of study form, could not definitely count as completion or discontinuation | 0 | 1 |
| Withdrew: Switched back to previous medication | 1 | 0 |
| Withdrew: Did not want to take medication | 1 | 0 |
| Withdrew: Subject could not afford medication | 0 | 1 |
| Withdrew: Site closed | 2 | 3 |
| Withdrew: Incorrectly randomized | 16 | 6 |
| Withdrew: Entered into electronic data capture in error | 0 | 1 |
| Withdrew: Physician decision | 0 | 3 |
| Withdrew: Subject transferred to another facility | 0 | 1 |
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.
| Months | Stiolto® Respimat® | ICS Plus LABA Plus LAMA (Triple Therapy) |
|---|---|---|
| Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over the 12 Month Study Period | NA (NA to NA) | NA (NA to NA) |
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.
| Exacerbations per participant per year | Stiolto® Respimat® | Triple Therapy |
|---|---|---|
| Annual Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | 0.36 (0.28 to 0.47) | 0.26 (0.19 to 0.34) |
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.
| Months | Stiolto® Respimat® | ICS Plus LABA Plus LAMA (Triple Therapy) |
|---|---|---|
| Time to First Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over 12 Months of Treatment Pulmonary Disease | NA (NA to NA) | NA (NA to NA) |
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.
| Exacerbations per participant per year | Stiolto® Respimat® | Triple Therapy |
|---|---|---|
| Annual Rate of Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations | 0.07 (0.04 to 0.12) | 0.07 (0.04 to 0.11) |
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).
| Participants | Stiolto® Respimat® | Triple Therapy |
|---|---|---|
| Number of Patients With Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Over the 12 Month Observation Period | 73 | 62 |
Collected over Up to 12 months + 21 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stiolto® Respimat® | 12/356 (3.4%) | 56/325 (17.2%) | 0/325 (0%) |
| ICS Plus LABA Plus LAMA (Triple Therapy) | 12/358 (3.4%) | 45/318 (14.2%) | 0/318 (0%) |
| Event | Stiolto® Respimat® | ICS Plus LABA Plus LAMA (Triple Therapy) |
|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 20/325 | 19/318 |
| PneumoniaInfections and infestations | 6/325 | 9/318 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 2/325 | 7/318 |
| Blood pressure increasedInvestigations | 5/325 | 2/318 |
| Infective exacerbation of chronic obstructive airways diseaseInfections and infestations | 4/325 | 1/318 |
| SepsisInfections and infestations | 4/325 | 3/318 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 4/325 | 2/318 |
| Cardiac failureCardiac disorders | 1/325 | 3/318 |
| Cardiac arrestCardiac disorders | 3/325 | 1/318 |
| Cardiac failure acuteCardiac disorders | 3/325 | 0/318 |
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.
| Age, Continuous(years) | Stiolto® Respimat® | ICS Plus LABA Plus LAMA (Triple Therapy) | Total |
|---|---|---|---|
| Mean | 69.0 ± 9.32 | 69.9 ± 9.81 | 69.5 ± 9.57 |
| Sex/Gender, Customized(Participants) | Stiolto® Respimat® | ICS Plus LABA Plus LAMA (Triple Therapy) | Total |
|---|---|---|---|
| Male | 181 | 174 | 355 |
| Female | 169 | 181 | 350 |
| Missing | 6 | 3 | 9 |
| Ethnicity (NIH/OMB)(Participants) | Stiolto® Respimat® | ICS Plus LABA Plus LAMA (Triple Therapy) | Total |
|---|---|---|---|
| Hispanic or Latino | 20 | 20 | 40 |
| Not Hispanic or Latino | 329 | 334 | 663 |
| Unknown or Not Reported | 7 | 4 | 11 |
| Race/Ethnicity, Customized(Participants) | Stiolto® Respimat® | ICS Plus LABA Plus LAMA (Triple Therapy) | Total |
|---|---|---|---|
| White or Caucasian | 292 | 300 | 592 |
| Black or African American | 42 | 38 | 80 |
| Asian | 6 | 7 | 13 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| American Indian or Alaska Native | 1 | 0 | 1 |
| Other | 9 | 9 | 18 |
| Missing | 6 | 3 | 9 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: 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.
Access criteria: 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.
Data sharing details ↗ · www.mystudywindow.com
Ran from Sep 2017 to primary completion in Sep 2020, 36 months.
Results were first posted in Dec 2021, 1 year 2 months after primary completion.
Of 71 industry-sponsored phase 4 interventional studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 22. This study's 36 months is above that.
Counting every sponsor, half of 157 studies reached it within 19 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tiotropium-olodaterol
Pulmonary Disease, Chronic Obstructive →