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
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:
Currently on one of the following maintenance therapies:
Exclusion Criteria:
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 |
Documents are hosted by the registry — open the source record to download them.
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, Sap, Csr
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Boehringer Ingelheim