A Phase 3 interventional study of SUN-101 50 mcg BID eFlow (CS) nebulizer and SUN-101 25 mcg BID eFlow (CS) nebulizer in COPD, sponsored by Sunovion Respiratory Development Inc.. Completed at 44 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2018-03-22.
Sponsored by Sunovion Respiratory Development Inc. · Phase 3, Interventional, and Treatment
This is a trial of 12 weeks of treatment with nebulized SUN-101 using an Investigational eFlow® Closed System (CS) nebulizer in subjects with chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014) guidelines.
This is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter, efficacy and safety trial of 12 weeks of treatment with nebulized SUN-101 using an Investigational eFlow® Closed System (CS) nebulizer in approximately 645 subjects with chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014) guidelines.
SUN-101 or placebo will be administered twice daily as an oral inhalation using the investigational eFlow CS nebulizer. Approximately 150 subjects will be enrolled in the substudy (at selected sites only). These subjects will be required to participate in serial spirometry, vital signs, ECGs, and an additional Holter monitor assessment at Visit 6 (Week 12). This subset of subjects will be referred to as the Substudy Population.
Sunovion Respiratory Development Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
Drug: SUN-101 50 mcg BID eFlow (CS) nebulizer
SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer
Drug: SUN-101 25 mcg BID eFlow (CS) nebulizer
Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer
Drug: Placebo BID eFlow Closed System (CS) nebulizer
SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
Placebo twice daily (BID) eFlow Closed System (CS) nebulizer
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12
ALL COLLECTED-Spirometry was performed according to internationally accepted standards.Trough FEV1 at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose.Change from baseline in trough FEV1 was calculated as the trough FEV1 value at Week 12 minus the morning trough FEV1 at baseline (mean of the two pre-dose values at 45 and 15 minutes prior to the first dose). All collected values were used in this analyses, regardless if the subject remained on randomized treatment or not, and regardless if the values might potentially be affected by other therapies or not Values not collected remained as missing values and were assumed to be missing at random (MAR) "ALL COLLECTED" and "ON TREATMENT" data are the same. The only difference is in the number of visits included for those participants who may have discontinued randomized treatment but remained in the study." for all endpoints
Time frame: Baseline and Week 12
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) Week 12
ON TEATMENT-Spirometry was performed according to internationally accepted standards.Trough FEV1 at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose.Change from baseline in trough FEV1 was calculated as the trough FEV1 value at Week 12 minus the morning trough FEV1 at baseline (mean of the two pre-dose values at 45 and 15 minutes prior to the first dose).Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR).
Time frame: Baseline and Week 12
Standardized Change From Baseline at Week 12 in FEV1 Area Under the Curve (AUC) (0-12) in the Substudy Population
ALL COLLECTED The standardized FEV1 AUC(0-12) was calculated at weeks 0 and 12 for the Substudy Population with extended spirometry measurements. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time. Intermittent missing spirometry measurements were ignored and the trapezoidal rule would simply span the missing time point(s). If the Hour 12 time point was missing, then the AUC(0-12) calculation was based on the time interval up to the last non-missing time point prior to Hour 12. If a subject has a missing baseline FEV1, then that subject had a missing AUC. All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not, and regardless if the values might potentially be affected by other therapies or not Values not collected remained as missing values and were assumed to be missing at random (MAR).
Time frame: Baseline and Week 12
Standardized Change From Baseline at Week 12 in FEV1 Area Under the Curve (AUC) (0-12) in Substudy Population
ON TREATMENT The standardized FEV1 AUC(0-12) was calculated at weeks 0 and 12 for the Substudy Population with extended spirometry measurements. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time. Intermittent missing spirometry measurements were ignored and the trapezoidal rule would simply span the missing time points. If the Hour 12 time point was missing, then the AUC(0-12) calculation was based on the time interval up to the last non-missing time point prior to Hour 12. If a subject has a missing baseline FEV1, then that subject had a missing AUC.Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR).
Time frame: Baseline and Week 12
Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 12
ALL COLLECTED Spirometry was performed according to internationally accepted standards. Trough FVC at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose. All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not, and regardless if the values might potentially be affected by other therapies or not Values not collected remained as missing values and were assumed to be missing at random
Time frame: Baseline and Week 12
Change From Baseline in Trough Forced Vital Capacity (FVC) Week 12
ON TREATMENT Spirometry was performed according to internationally accepted standards. Trough FVC at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose. Change from baseline in trough FVC was calculated as the trough FVC value at Week 12 minus the morning trough FVC at baseline (mean of the two pre-dose values at 45 and 15 minutes prior to the first dose).Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR).
Time frame: Baseline and Week 12
Change From Baseline in Health Status Measured by St. George's Respiratory Questionnaire (SGRQ) at Week 12/End of Study
ALL COLLECTED Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: symptoms, activity, and impacts. A score was calculated for each of these 3 subscales and a "Total" score was calculated. In each case the lowest possible value is 0 and the highest 100. Higher values correspond to greater impairment of health status. All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not. Values not collected remained as missing values and were assumed to be missing at random (MAR).
Time frame: Baseline and Week 12
Change From Baseline in Health Status Measured by St. George's Respiratory Questionnaire (SGRQ) Week 12/End of Study
ON TREATMENT Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: symptoms, activity, and impacts. A score was calculated for each of these 3 subscales and a "Total" score was calculated. In each case the lowest possible value is 0 and the highest 100. Higher values correspond to greater impairment of health status. Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR).
Time frame: Baseline and Week 12
Change in Number of Rescue Medication Puffs Per Day Over the 12-week Double-blind Treatment Period
ALL COLLECTED Participants completed an electronic diary (eDiary) daily (night time) to record the number of puffs of rescue medication inhaled in the previous 24 hours. A negative change from baseline indicates improvement. All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not. Values not collected remained as missing values and were assumed to be missing at random (MAR).
Time frame: Week 0-12
Number of Subjects With Major Adverse Cardiac Events (MACE)
ALL COLLECTED All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs "myocardial infarction", "other ischemic heart disease", "central nervous system hemorrhages and cerebrovascular conditions") were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected for the double-blind period (from the first date of study medication until the date of last contact)
Time frame: Week 0-12
Percentage of Subjects With Major Cardiac Events (MACE)
ALL COLLECTED All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs "myocardial infarction", "other ischemic heart disease", "central nervous system hemorrhages and cerebrovascular conditions") were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected for the double-blind period (from the first date of study medication until the date of last contact)
Time frame: Week 0-12
Number of Subjects With Treatment Emergent Adverse Events (TEAE)
ON TREATMENT A TEAE is defined as any non-serious AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.
Time frame: Week 0-12
Percent of Subjects With Treatment Emergent Adverse Events (TEAE)
ON TREATMENT A TEAE is defined as any non-serious AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.
Time frame: Week 0-12
Number of Subjects With Treatment Emergent Serious Adverse Events (SAE)
ON TREATMENT A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE
Time frame: Week 0-12
Percent of Subjects With Treatment Emergent Serious Adverse Events (SAE)
ON TREATMENT A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE
Time frame: Week 0-12
Number of Subjects Who Discontinue Treatment Due to TEAE
ON TREATMENT A TEAE is defined as any AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.
Time frame: Week 0-12
Percent of Subjects Who Discontinue Treatment Due to TEAE
ON TREATMENT A TEAE is defined as any AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.
Time frame: Week 0-12
Incidence Rate Per 100 Person-years of Subjects With Treatment Emergent Adverse Events (TEAE)
ALL COLLECTED All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs "myocardial infarction", "other ischemic heart disease", "central nervous system hemorrhages and cerebrovascular conditions") were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected for the double-blind period (from the first date of study medication until the date of last contact)I ncidence rate: TT= Total Time in years. Total Time (TT) is defined as the time from the first date of study drug until the latter of the date of last contact or 30 days after the date of last dose. Incidence Rate (per 1000 person-years) = n/TT x 1000.
Time frame: Week 0-12
| Milestone | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg BID eFlow (CS) Nebulizer | Placebo BID eFlow (CS) Nebulizer |
|---|---|---|---|
| Started | 218 | 217 | 218 |
| Completed | 201 | 203 | 191 |
| Not completed | 17 | 14 | 27 |
| Withdrew: Death | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 3 | 2 | 3 |
| Withdrew: Withdrawal by subject | 11 | 11 | 22 |
| Withdrew: Invetigator disretion | 2 | 0 | 0 |
| Withdrew: Instillation site pain | 0 | 0 | 1 |
| Withdrew: Exacerbation of copd | 0 | 0 | 1 |
| Withdrew: Moved/travel | 0 | 1 | 0 |
| Milestone | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg BID eFlow (CS) Nebulizer | Placebo BID eFlow (CS) Nebulizer |
|---|---|---|---|
| Started | 218 | 217 | 218 |
| Completed | 191 | 194 | 176 |
| Not completed | 27 | 23 | 42 |
| Withdrew: Lack of efficacy | 2 | 3 | 4 |
| Withdrew: Non-compliance with study medication | 0 | 0 | 2 |
| Withdrew: Withdrawal by subject | 7 | 3 | 5 |
| Withdrew: Move/travel | 2 | 6 | 5 |
| Withdrew: Dissastisfaction with device | 2 | 1 | 4 |
| Withdrew: Lost to follow-up | 2 | 1 | 1 |
| Withdrew: Investigator discretion | 2 | 0 | 0 |
| Withdrew: Durg not working | 0 | 1 | 1 |
| Withdrew: Adverse event | 10 | 8 | 20 |
ALL COLLECTED-Spirometry was performed according to internationally accepted standards.Trough FEV1 at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose.Change from baseline in trough FEV1 was calculated as the trough FEV1 value at Week 12 minus the morning trough FEV1 at baseline (mean of the two pre-dose values at 45 and 15 minutes prior to the first dose). All collected values were used in this analyses, regardless if the subject remained on randomized treatment or not, and regardless if the values might potentially be affected by other therapies or not Values not collected remained as missing values and were assumed to be missing at random (MAR) "ALL COLLECTED" and "ON TREATMENT" data are the same. The only difference is in the number of visits included for those participants who may have discontinued randomized treatment but remained in the study." for all endpoints
| liters | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg BID eFlow (CS) Nebulizer | Placebo BID eFlow (CS) Nebulizer |
|---|---|---|---|
| Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 | 0.0961 ± 0.01371 | 0.0886 ± 0.01369 | -0.0075 ± 0.01397 |
ON TEATMENT-Spirometry was performed according to internationally accepted standards.Trough FEV1 at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose.Change from baseline in trough FEV1 was calculated as the trough FEV1 value at Week 12 minus the morning trough FEV1 at baseline (mean of the two pre-dose values at 45 and 15 minutes prior to the first dose).Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR).
| liters | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg BID eFlow (CS) Nebulizer | Placebo BID eFlow (CS) Nebulizer |
|---|---|---|---|
| Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) Week 12 | 0.1025 ± 0.01497 | 0.0814 ± 0.01475 | -0.0238 ± 0.01534 |
ALL COLLECTED The standardized FEV1 AUC(0-12) was calculated at weeks 0 and 12 for the Substudy Population with extended spirometry measurements. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time. Intermittent missing spirometry measurements were ignored and the trapezoidal rule would simply span the missing time point(s). If the Hour 12 time point was missing, then the AUC(0-12) calculation was based on the time interval up to the last non-missing time point prior to Hour 12. If a subject has a missing baseline FEV1, then that subject had a missing AUC. All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not, and regardless if the values might potentially be affected by other therapies or not Values not collected remained as missing values and were assumed to be missing at random (MAR).
| liters | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg BID eFlow (CS) Nebulizer | Placebo BID eFlow (CS) Nebulizer |
|---|---|---|---|
| Standardized Change From Baseline at Week 12 in FEV1 Area Under the Curve (AUC) (0-12) in the Substudy Population | 0.0749 ± 0.02638 | 0.0579 ± 0.3011 | -0.0474 ± 0.03229 |
ON TREATMENT The standardized FEV1 AUC(0-12) was calculated at weeks 0 and 12 for the Substudy Population with extended spirometry measurements. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time. Intermittent missing spirometry measurements were ignored and the trapezoidal rule would simply span the missing time points. If the Hour 12 time point was missing, then the AUC(0-12) calculation was based on the time interval up to the last non-missing time point prior to Hour 12. If a subject has a missing baseline FEV1, then that subject had a missing AUC.Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR).
| liters | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg BID eFlow (CS) Nebulizer | Placebo BID eFlow (CS) Nebulizer |
|---|---|---|---|
| Standardized Change From Baseline at Week 12 in FEV1 Area Under the Curve (AUC) (0-12) in Substudy Population | 0.0708 ± 0.02792 | 0.0496 ± 0.03280 | -0.0527 ± 0.03450 |
ALL COLLECTED Spirometry was performed according to internationally accepted standards. Trough FVC at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose. All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not, and regardless if the values might potentially be affected by other therapies or not Values not collected remained as missing values and were assumed to be missing at random
| liters | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg BID eFlow (CS) Nebulizer | Placebo BID eFlow (CS) Nebulizer |
|---|---|---|---|
| Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 12 | 0.1476 ± 0.02226 | 0.1515 ± 0.02220 | 0.0147 ± 0.2266 |
ON TREATMENT Spirometry was performed according to internationally accepted standards. Trough FVC at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose. Change from baseline in trough FVC was calculated as the trough FVC value at Week 12 minus the morning trough FVC at baseline (mean of the two pre-dose values at 45 and 15 minutes prior to the first dose).Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR).
| liters | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg BID eFlow (CS) Nebulizer | Placebo BID eFlow (CS) Nebulizer |
|---|---|---|---|
| Change From Baseline in Trough Forced Vital Capacity (FVC) Week 12 | 0.1566 ± 0.02392 | 0.1393 ± 0.02353 | -0.0101 ± 0.2450 |
ALL COLLECTED Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: symptoms, activity, and impacts. A score was calculated for each of these 3 subscales and a "Total" score was calculated. In each case the lowest possible value is 0 and the highest 100. Higher values correspond to greater impairment of health status. All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not. Values not collected remained as missing values and were assumed to be missing at random (MAR).
| scores on a scale | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg BID eFlow (CS) Nebulizer | Placebo BID eFlow (CS) Nebulizer |
|---|---|---|---|
| Change From Baseline in Health Status Measured by St. George's Respiratory Questionnaire (SGRQ) at Week 12/End of Study | -2.363 ± 0.8344 | -4.250 ± 0.8211 | -0.844 ± 0.8396 |
ON TREATMENT Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: symptoms, activity, and impacts. A score was calculated for each of these 3 subscales and a "Total" score was calculated. In each case the lowest possible value is 0 and the highest 100. Higher values correspond to greater impairment of health status. Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR).
| scores on a scale | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg BID eFlow (CS) Nebulizer | Placebo BID eFlow (CS) Nebulizer |
|---|---|---|---|
| Change From Baseline in Health Status Measured by St. George's Respiratory Questionnaire (SGRQ) Week 12/End of Study | -2.538 ± 0.8391 | -3.762 ± 0.8187 | -0.690 ± 0.8535 |
ALL COLLECTED Participants completed an electronic diary (eDiary) daily (night time) to record the number of puffs of rescue medication inhaled in the previous 24 hours. A negative change from baseline indicates improvement. All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not. Values not collected remained as missing values and were assumed to be missing at random (MAR).
| puffs (medication used) | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg BID eFlow (CS) Nebulizer | Placebo BID eFlow (CS) Nebulizer |
|---|---|---|---|
| Change in Number of Rescue Medication Puffs Per Day Over the 12-week Double-blind Treatment Period | -0.815 ± 0.1234 | -0.609 ± 0.1259 | -0.632 ± 0.1257 |
ALL COLLECTED All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs "myocardial infarction", "other ischemic heart disease", "central nervous system hemorrhages and cerebrovascular conditions") were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected for the double-blind period (from the first date of study medication until the date of last contact)
| participants | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg BID eFlow (CS) Nebulizer | Placebo BID eFlow (CS) Nebulizer |
|---|---|---|---|
| MACE score | 3 | 0 | 0 |
| Cardiovascular Death | 1 | 0 | 0 |
| non-fatal myocardial infraction | 1 | 0 | 0 |
| non-fatal stroke | 1 | 0 | 0 |
ALL COLLECTED All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs "myocardial infarction", "other ischemic heart disease", "central nervous system hemorrhages and cerebrovascular conditions") were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected for the double-blind period (from the first date of study medication until the date of last contact)
| percentage of participants | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg BID eFlow (CS) Nebulizer | Placebo BID eFlow (CS) Nebulizer |
|---|---|---|---|
| MACE score | 1.4 | 0 | 0 |
| Cardiovascular Death | 0.5 | 0 | 0 |
| non-fatal myocardial infraction | 0.5 | 0 | 0 |
| non-fatal stroke | 0.5 | 0 | 0 |
ON TREATMENT A TEAE is defined as any non-serious AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.
| participants | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg BID eFlow (CS) Nebulizer | Placebo BID eFlow (CS) Nebulizer |
|---|---|---|---|
| Number of Subjects With Treatment Emergent Adverse Events (TEAE) | 105 | 86 | 114 |
ON TREATMENT A TEAE is defined as any non-serious AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.
| percentage of participants | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg BID eFlow (CS) Nebulizer | Placebo BID eFlow (CS) Nebulizer |
|---|---|---|---|
| Percent of Subjects With Treatment Emergent Adverse Events (TEAE) | 48.2 | 39.6 | 52.3 |
ON TREATMENT A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE
| participants | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg BID eFlow (CS) Nebulizer | Placebo BID eFlow (CS) Nebulizer |
|---|---|---|---|
| Number of Subjects With Treatment Emergent Serious Adverse Events (SAE) | 10 | 8 | 11 |
ON TREATMENT A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE
| percentage of participants | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg BID eFlow (CS) Nebulizer | Placebo BID eFlow (CS) Nebulizer |
|---|---|---|---|
| Percent of Subjects With Treatment Emergent Serious Adverse Events (SAE) | 4.6 | 3.7 | 5.0 |
ON TREATMENT A TEAE is defined as any AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.
| participants | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg BID eFlow (CS) Nebulizer | Placebo BID eFlow (CS) Nebulizer |
|---|---|---|---|
| Number of Subjects Who Discontinue Treatment Due to TEAE | 8 | 7 | 21 |
ON TREATMENT A TEAE is defined as any AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.
| percentage of participants | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg BID eFlow (CS) Nebulizer | Placebo BID eFlow (CS) Nebulizer |
|---|---|---|---|
| Percent of Subjects Who Discontinue Treatment Due to TEAE | 3.7 | 3.2 | 9.6 |
ALL COLLECTED All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs "myocardial infarction", "other ischemic heart disease", "central nervous system hemorrhages and cerebrovascular conditions") were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected for the double-blind period (from the first date of study medication until the date of last contact)I ncidence rate: TT= Total Time in years. Total Time (TT) is defined as the time from the first date of study drug until the latter of the date of last contact or 30 days after the date of last dose. Incidence Rate (per 1000 person-years) = n/TT x 1000.
| events per 100 person-years | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg BID eFlow (CS) Nebulizer | Placebo BID eFlow (CS) Nebulizer |
|---|---|---|---|
| MACE score | 45.5 | 0 | 0 |
| Cardiovascular Death | 15.2 | 0 | 0 |
| non-fatal myocardial infraction | 15.2 | 0 | 0 |
| non-fatal stroke | 15.2 | 0 | 0 |
Collected over Week 0-12. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SUN-101 50 mcg BID eFlow (CS) Nebulizer | — | 10/218 (4.6%) | 37/218 (17%) |
| SUN-101 25 mcg BID eFlow (CS) Nebulizer | — | 8/217 (3.7%) | 23/217 (10.6%) |
| Placebo BID eFlow (CS) Nebulizer | — | 11/218 (5%) | 38/218 (17.4%) |
| Event | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg BID eFlow (CS) Nebulizer | Placebo BID eFlow (CS) Nebulizer |
|---|---|---|---|
| chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 4/218 | 2/217 | 2/218 |
| pneumoniaImmune system disorders | 2/218 | 0/217 | 0/218 |
| angina pectorisCardiac disorders | 0/218 | 1/217 | 0/218 |
| coronary artery stenosisCardiac disorders | 0/218 | 1/217 | 0/218 |
| small intestinal obstructionGastrointestinal disorders | 0/218 | 1/217 | 0/218 |
| pyelonephritisInfections and infestations | 0/218 | 1/217 | 0/218 |
| lung adenocarcinoma stage IVNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/218 | 1/217 | 0/218 |
| carotid artery stenosisNervous system disorders | 0/218 | 1/217 | 0/218 |
| obstructive uropathyRenal and urinary disorders | 0/218 | 1/217 | 0/218 |
| angina unstableCardiac disorders | 1/218 | 0/217 | 1/218 |
| Event | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg BID eFlow (CS) Nebulizer | Placebo BID eFlow (CS) Nebulizer |
|---|---|---|---|
| coughRespiratory, thoracic and mediastinal disorders | 21/218 | 16/217 | 22/218 |
| chronic obstructive ulmonary diseaseRespiratory, thoracic and mediastinal disorders | 19/218 | 9/217 | 17/218 |
| Age, Categorical(Participants) | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg BID eFlow (CS) Nebulizer | Placebo BID eFlow (CS) Nebulizer | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 135 | 122 | 109 | 366 |
| >=65 years | 83 | 95 | 109 | 287 |
| Age, Continuous(years) | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg BID eFlow (CS) Nebulizer | Placebo BID eFlow (CS) Nebulizer | Total |
|---|---|---|---|---|
| Mean | 62.5 ± 8.09 | 63.1 ± 8.78 | 63.7 ± 8.37 | 63.1 ± 8.42 |
| Sex: Female, Male(Participants) | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg BID eFlow (CS) Nebulizer | Placebo BID eFlow (CS) Nebulizer | Total |
|---|---|---|---|---|
| Female | 98 | 99 | 107 | 304 |
| Male | 120 | 118 | 111 | 349 |
| Ethnicity (NIH/OMB)(Participants) | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg BID eFlow (CS) Nebulizer | Placebo BID eFlow (CS) Nebulizer | Total |
|---|---|---|---|---|
| Hispanic or Latino | 6 | 7 | 6 | 19 |
| Not Hispanic or Latino | 212 | 210 | 212 | 634 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg BID eFlow (CS) Nebulizer | Placebo BID eFlow (CS) Nebulizer | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 1 | 3 |
| Asian | 0 | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 1 |
| Black or African American | 18 | 15 | 20 | 53 |
| White | 198 | 200 | 196 | 594 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg BID eFlow (CS) Nebulizer | Placebo BID eFlow (CS) Nebulizer | Total |
|---|---|---|---|---|
| United States | 218 | 217 | 218 | 653 |
| cardiovascular risk (low/high) and categories for high caridovascular risk(Participants) | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg BID eFlow (CS) Nebulizer | Placebo BID eFlow (CS) Nebulizer | Total |
|---|---|---|---|---|
| low cardiovascular risk | 77 | 78 | 76 | 231 |
| high cardiovascular risk | 141 | 139 | 142 | 422 |
| cerebrovascular disease | 10 | 13 | 14 | 37 |
| peripheral arterial disease | 10 | 13 | 14 | 37 |
| clinically significant arrhythmia | 7 | 13 | 2 | 22 |
| heart failure | 9 | 7 | 8 | 24 |
| hyertension | 127 | 128 | 138 | 393 |
| background long-acting beta(2) agonist (LABA) use(Participants) | SUN-101 50 mcg BID eFlow (CS) Nebulizer | SUN-101 25 mcg BID eFlow (CS) Nebulizer | Placebo BID eFlow (CS) Nebulizer | Total |
|---|---|---|---|---|
| background LABA use =yes | 68 | 66 | 63 | 197 |
| background LABA use =no | 150 | 151 | 155 | 456 |
1 further baseline measures are reported on the registry.
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Sunovion Respiratory Development Inc.