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Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD (GOLDEN-3)

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ClinicalTrials.gov Identifier: NCT02347761
Recruitment Status : Completed
First Posted : January 27, 2015
Results First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Sunovion Respiratory Development Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition COPD
Interventions Drug: SUN-101 50 mcg BID eFlow (CS) nebulizer
Drug: SUN-101 25 mcg BID eFlow (CS) nebulizer
Drug: Placebo BID eFlow Closed System (CS) nebulizer
Enrollment 653
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID eFlow (CS) Nebulizer Placebo BID eFlow (CS) Nebulizer
Hide Arm/Group Description

SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer

Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer

Period Title: All Collected
Started 218 217 218
Completed 201 203 191
Not Completed 17 14 27
Reason Not Completed
Death             1             0             0
Lost to Follow-up             3             2             3
Withdrawal by Subject             11             11             22
invetigator disretion             2             0             0
instillation site pain             0             0             1
exacerbation of COPD             0             0             1
moved/travel             0             1             0
Period Title: On Study Treatment
Started 218 217 218
Completed 191 194 176
Not Completed 27 23 42
Reason Not Completed
Lack of Efficacy             2             3             4
non-compliance with study medication             0             0             2
Withdrawal by Subject             7             3             5
move/travel             2             6             5
dissastisfaction with device             2             1             4
Lost to Follow-up             2             1             1
investigator discretion             2             0             0
durg not working             0             1             1
Adverse Event             10             8             20
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID eFlow (CS) Nebulizer Placebo BID eFlow (CS) Nebulizer Total
Hide Arm/Group Description

SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer

Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer

Total of all reporting groups
Overall Number of Baseline Participants 218 217 218 653
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 218 participants 217 participants 218 participants 653 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
135
  61.9%
122
  56.2%
109
  50.0%
366
  56.0%
>=65 years
83
  38.1%
95
  43.8%
109
  50.0%
287
  44.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 218 participants 217 participants 218 participants 653 participants
62.5  (8.09) 63.1  (8.78) 63.7  (8.37) 63.1  (8.42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 218 participants 217 participants 218 participants 653 participants
Female
98
  45.0%
99
  45.6%
107
  49.1%
304
  46.6%
Male
120
  55.0%
118
  54.4%
111
  50.9%
349
  53.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 218 participants 217 participants 218 participants 653 participants
Hispanic or Latino
6
   2.8%
7
   3.2%
6
   2.8%
19
   2.9%
Not Hispanic or Latino
212
  97.2%
210
  96.8%
212
  97.2%
634
  97.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 218 participants 217 participants 218 participants 653 participants
American Indian or Alaska Native
1
   0.5%
1
   0.5%
1
   0.5%
3
   0.5%
Asian
0
   0.0%
1
   0.5%
1
   0.5%
2
   0.3%
Native Hawaiian or Other Pacific Islander
1
   0.5%
0
   0.0%
0
   0.0%
1
   0.2%
Black or African American
18
   8.3%
15
   6.9%
20
   9.2%
53
   8.1%
White
198
  90.8%
200
  92.2%
196
  89.9%
594
  91.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 218 participants 217 participants 218 participants 653 participants
218 217 218 653
cardiovascular risk (low/high) and categories for high caridovascular risk   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 218 participants 217 participants 218 participants 653 participants
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
[1]
Measure Description: Cardiovascular risk was stratified as low versus high risk where the high risk stratum was defined as any participant with a pre-existing diagnosis of ischemic heart cardiovascular risk disease, cerebrovascular disease, peripheral arterial disease, hypertension, clinically significant arrhythmia or heart failure.
background long-acting beta(2) agonist (LABA) use   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 218 participants 217 participants 218 participants 653 participants
background LABA use =yes 68 66 63 197
background LABA use =no 150 151 155 456
[1]
Measure Description: background LABA [+/- ICS] use was stratified as "yes" or "no" where the continuation of background therapy, in approximately 30% of the study population, required the subject to be on a stable dose of the medication for 4 weeks prior to study entry.
Forced expiratory volume in one second (FEV1)   [1] 
Mean (Standard Deviation)
Unit of measure:  Liters
Number Analyzed 218 participants 217 participants 218 participants 653 participants
1.3745  (0.52957) 1.3108  (0.50243) 1.3122  (0.47511) 1.3325  (0.50297)
[1]
Measure Description: spirometry was performed according to internationally accepted standards. Baseline FEV1 is defined as the mean of the two dose values at 45 and 15 minutes prior to first dose.
1.Primary Outcome
Title Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID eFlow (CS) Nebulizer Placebo BID eFlow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer

Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer

Overall Number of Participants Analyzed 218 217 218
Least Squares Mean (Standard Error)
Unit of Measure: liters
0.0961  (0.01371) 0.0886  (0.01369) -0.0075  (0.01397)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SUN-101 50 mcg BID eFlow (CS) Nebulizer, Placebo BID eFlow (CS) Nebulizer
Comments The change from baseline in trough FEV1 was analyzed using a mixed model for repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit, visit by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.
Type of Statistical Test Superiority
Comments A sample size of 215 subjects per treatment would give ~ 90% power to detect a treatment difference of 80 mL in the change from baseline in trough FEV1 at Week 12 between each of the 2 SUN-101 dose groups and placebo at alpha= 0.05, assuming a standard deviation of 255 mL and using a 2-sided test.
Statistical Test of Hypothesis P-Value <0.0001
Comments The primary null hypothesis for this study is that the mean change from baseline in trough FEV1 at Week 12 for the SUN-101 50 mcg dose is equal to the mean change from baseline in trough FEV1 at Week 12 for Placebo.
Method MMixed Model Repeat Measurement
Comments to control the family-wise Type I error rate,the Hochberg procedure(a tree-structured gatekeeping procedure)was used for comparisons of this endpoint
Method of Estimation Estimation Parameter Least Squares Mea Difference (SE)
Estimated Value 0.1036
Confidence Interval (2-Sided) 95%
0.0663 to 0.1409
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.01900
Estimation Comments standard error of the least squares mean
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SUN-101 25 mcg BID eFlow (CS) Nebulizer, Placebo BID eFlow (CS) Nebulizer
Comments The change from baseline in trough FEV1 was analyzed using a mixed model for repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit, visit by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.
Type of Statistical Test Superiority
Comments A sample size of 215 subjects per treatment would give ~ 90% power to detect a treatment difference of 80 mL in the change from baseline in trough FEV1 at Week 12 between each of the 2 SUN-101 dose groups and placebo at alpha= 0.05, assuming a standard deviation of 255 mL and using a 2-sided test.
Statistical Test of Hypothesis P-Value <0.0001
Comments The primary null hypothesis for this study is that the mean change from baseline in trough FEV1 at Week 12 for the SUN-101 50 mcg dose is equal to the mean change from baseline in trough FEV1 at Week 12 for Placebo.
Method Mixed Model Repeat Measurement
Comments to control the family-wise Type I error rate,the Hochberg procedure(a tree-structured gatekeeping procedure)was used for comparisons of the endpoint.
Method of Estimation Estimation Parameter Least Squares Mean Difference (SE)
Estimated Value 0.0961
Confidence Interval (2-Sided) 95%
0.0589 to 0.1334
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.01896
Estimation Comments Standard error of the least squares mean
2.Primary Outcome
Title Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID eFlow (CS) Nebulizer Placebo BID eFlow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer

Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer

Overall Number of Participants Analyzed 218 217 218
Least Squares Mean (Standard Error)
Unit of Measure: liters
0.1025  (0.01497) 0.0814  (0.01475) -0.0238  (0.01534)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SUN-101 50 mcg BID eFlow (CS) Nebulizer, Placebo BID eFlow (CS) Nebulizer
Comments The change from baseline in trough FEV1 was analyzed using mixed model repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.
Method Least squares mean (SE)
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean (SE)
Estimated Value 0.1264
Confidence Interval (2-Sided) 95%
0.0856 to 0.1672
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02076
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SUN-101 25 mcg BID eFlow (CS) Nebulizer, Placebo BID eFlow (CS) Nebulizer
Comments The change from baseline in trough FEV1 was analyzed using mixed model repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.
Type of Statistical Test Superiority
Comments In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method LS mean (SE)
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean (SE)
Estimated Value 0.1052
Confidence Interval (2-Sided) 95%
0.0647 to 0.1457
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02060
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Standardized Change From Baseline at Week 12 in FEV1 Area Under the Curve (AUC) (0-12) in the Substudy Population
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Substudy Population consisted of all ITT subjects who participated in post-dose serial measurements
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID eFlow (CS) Nebulizer Placebo BID eFlow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer

Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer

Overall Number of Participants Analyzed 62 49 42
Least Squares Mean (Standard Error)
Unit of Measure: liters
0.0749  (0.02638) 0.0579  (0.3011) -0.0474  (0.03229)
4.Secondary Outcome
Title Standardized Change From Baseline at Week 12 in FEV1 Area Under the Curve (AUC) (0-12) in Substudy Population
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Substudy Population consisted of all ITT subjects who participated in post-dose serial measurements, including serial spirometry, serial ECGs, serial vital sign measurements, as well as Holter monitoring at Visit 6.
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID eFlow (CS) Nebulizer Placebo BID eFlow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer

Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer

Overall Number of Participants Analyzed 62 49 42
Least Squares Mean (Standard Error)
Unit of Measure: liters
0.0708  (0.02792) 0.0496  (0.03280) -0.0527  (0.03450)
5.Secondary Outcome
Title Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 12
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID eFlow (CS) Nebulizer Placebo BID eFlow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer

Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer

Overall Number of Participants Analyzed 218 217 218
Least Squares Mean (Standard Error)
Unit of Measure: liters
0.1476  (0.02226) 0.1515  (0.02220) 0.0147  (0.2266)
6.Secondary Outcome
Title Change From Baseline in Trough Forced Vital Capacity (FVC) Week 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID eFlow (CS) Nebulizer Placebo BID eFlow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer

Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer

Overall Number of Participants Analyzed 218 217 218
Least Squares Mean (Standard Error)
Unit of Measure: liters
0.1566  (0.02392) 0.1393  (0.02353) -0.0101  (0.2450)
7.Secondary Outcome
Title Change From Baseline in Health Status Measured by St. George’s Respiratory Questionnaire (SGRQ) at Week 12/End of Study
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID eFlow (CS) Nebulizer Placebo BID eFlow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer

Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer

Overall Number of Participants Analyzed 218 217 218
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-2.363  (0.8344) -4.250  (0.8211) -0.844  (0.8396)
8.Secondary Outcome
Title Change From Baseline in Health Status Measured by St. George’s Respiratory Questionnaire (SGRQ) Week 12/End of Study
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID eFlow (CS) Nebulizer Placebo BID eFlow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer

Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer

Overall Number of Participants Analyzed 218 217 218
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-2.538  (0.8391) -3.762  (0.8187) -0.690  (0.8535)
9.Secondary Outcome
Title Change in Number of Rescue Medication Puffs Per Day Over the 12-week Double-blind Treatment Period
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID eFlow (CS) Nebulizer Placebo BID eFlow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer

Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer

Overall Number of Participants Analyzed 218 217 218
Least Squares Mean (Standard Error)
Unit of Measure: puffs (medication used)
-0.815  (0.1234) -0.609  (0.1259) -0.632  (0.1257)
10.Secondary Outcome
Title Number of Subjects With Major Adverse Cardiac Events (MACE)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID eFlow (CS) Nebulizer Placebo BID eFlow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer

Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer

Overall Number of Participants Analyzed 218 217 218
Measure Type: Number
Unit of Measure: participants
MACE score 3 0 0
Cardiovascular Death 1 0 0
non-fatal myocardial infraction 1 0 0
non-fatal stroke 1 0 0
11.Secondary Outcome
Title Percentage of Subjects With Major Cardiac Events (MACE)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID eFlow (CS) Nebulizer Placebo BID eFlow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer

Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer

Overall Number of Participants Analyzed 218 217 218
Measure Type: Number
Unit of Measure: percentage of participants
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
12.Secondary Outcome
Title Number of Subjects With Treatment Emergent Adverse Events (TEAE)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID eFlow (CS) Nebulizer Placebo BID eFlow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer

Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer

Overall Number of Participants Analyzed 218 217 218
Measure Type: Number
Unit of Measure: participants
105 86 114
13.Secondary Outcome
Title Percent of Subjects With Treatment Emergent Adverse Events (TEAE)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID eFlow (CS) Nebulizer Placebo BID eFlow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer

Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer

Overall Number of Participants Analyzed 218 217 218
Measure Type: Number
Unit of Measure: percentage of participants
48.2 39.6 52.3
14.Secondary Outcome
Title Number of Subjects With Treatment Emergent Serious Adverse Events (SAE)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID eFlow (CS) Nebulizer Placebo BID eFlow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer

Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer

Overall Number of Participants Analyzed 218 217 218
Measure Type: Number
Unit of Measure: participants
10 8 11
15.Secondary Outcome
Title Percent of Subjects With Treatment Emergent Serious Adverse Events (SAE)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID eFlow (CS) Nebulizer Placebo BID eFlow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer

Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer

Overall Number of Participants Analyzed 218 217 218
Measure Type: Number
Unit of Measure: percentage of participants
4.6 3.7 5.0
16.Secondary Outcome
Title Number of Subjects Who Discontinue Treatment Due to TEAE
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study meidcation
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID eFlow (CS) Nebulizer Placebo BID eFlow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer

Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer

Overall Number of Participants Analyzed 218 217 218
Measure Type: Number
Unit of Measure: participants
8 7 21
17.Secondary Outcome
Title Percent of Subjects Who Discontinue Treatment Due to TEAE
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study meidcation
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID eFlow (CS) Nebulizer Placebo BID eFlow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer

Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer

Overall Number of Participants Analyzed 218 217 218
Measure Type: Number
Unit of Measure: percentage of participants
3.7 3.2 9.6
18.Secondary Outcome
Title Incidence Rate Per 100 Person-years of Subjects With Treatment Emergent Adverse Events (TEAE)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID eFlow (CS) Nebulizer Placebo BID eFlow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer

Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer

Overall Number of Participants Analyzed 218 217 218
Measure Type: Number
Unit of Measure: events per 100 person-years
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
Time Frame Week 0-12
Adverse Event Reporting Description 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 does of study medication. A treatment emergent SAE is an on-treatment SAE
 
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID eFlow (CS) Nebulizer Placebo BID eFlow (CS) Nebulizer
Hide Arm/Group Description

SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 50 mcg BID eFlow (CS) nebulizer: SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

SUN-101 25 mcg twice daily (BID) eFlow (R) Closed System (CR) nebulizer

SUN-101 25 mcg BID eFlow (CS) nebulizer: SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer

Placebo twice daily (BID) eFlow (R) Closed System (CR) nebulizer

Placebo BID eFlow Closed System (CS) nebulizer: Placebo twice daily (BID) eFlow Closed System (CS) nebulizer

All-Cause Mortality
SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID eFlow (CS) Nebulizer Placebo BID eFlow (CS) Nebulizer
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID eFlow (CS) Nebulizer Placebo BID eFlow (CS) Nebulizer
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/218 (4.59%)      8/217 (3.69%)      11/218 (5.05%)    
Cardiac disorders       
angina pectoris  1  0/218 (0.00%)  0 1/217 (0.46%)  1 0/218 (0.00%)  0
angina unstable  1  1/218 (0.46%)  1 0/217 (0.00%)  0 1/218 (0.46%)  1
coronary artery stenosis  1  0/218 (0.00%)  0 1/217 (0.46%)  1 0/218 (0.00%)  0
diastolic dysfunction  1  1/218 (0.46%)  1 0/217 (0.00%)  0 0/218 (0.00%)  0
Gastrointestinal disorders       
small intestinal obstruction  1  0/218 (0.00%)  0 1/217 (0.46%)  1 0/218 (0.00%)  0
General disorders       
chest pain  1  1/218 (0.46%)  1 0/217 (0.00%)  0 0/218 (0.00%)  0
Hepatobiliary disorders       
gallbladder necrosis  1  1/218 (0.46%)  1 0/217 (0.00%)  0 0/218 (0.00%)  0
Immune system disorders       
pneumonia  1  2/218 (0.92%)  2 0/217 (0.00%)  0 0/218 (0.00%)  0
Infections and infestations       
bronchitis  1  0/218 (0.00%)  0 0/217 (0.00%)  0 1/218 (0.46%)  1
emphysematous cholecystitis  1  1/218 (0.46%)  1 0/217 (0.00%)  0 0/218 (0.00%)  0
lobar pheumonia  1  0/218 (0.00%)  0 0/217 (0.00%)  0 1/218 (0.46%)  1
pyelonephritis  1  0/218 (0.00%)  0 1/217 (0.46%)  1 0/218 (0.00%)  0
septic shock  1  1/218 (0.46%)  1 0/217 (0.00%)  0 0/218 (0.00%)  0
Injury, poisoning and procedural complications       
intentional overdose  1  1/218 (0.46%)  1 0/217 (0.00%)  0 0/218 (0.00%)  0
subdural haematoma  1  0/218 (0.00%)  0 0/217 (0.00%)  0 1/218 (0.46%)  1
Investigations       
antiphospholiid antibodies  1  0/218 (0.00%)  0 0/217 (0.00%)  0 1/218 (0.46%)  1
Metabolism and nutrition disorders       
dehydration  1  1/218 (0.46%)  1 0/217 (0.00%)  0 0/218 (0.00%)  0
diabetes mellitus inadequate control  1  0/218 (0.00%)  0 0/217 (0.00%)  0 1/218 (0.46%)  1
Musculoskeletal and connective tissue disorders       
arthralgia  1  0/218 (0.00%)  0 0/217 (0.00%)  0 1/218 (0.46%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
lung adenocarcinoma stage IV  1  0/218 (0.00%)  0 1/217 (0.46%)  1 0/218 (0.00%)  0
malignant neoplasm of pleura metastatic  1  0/218 (0.00%)  0 0/217 (0.00%)  0 1/218 (0.46%)  1
Nervous system disorders       
carotid artery stenosis  1  0/218 (0.00%)  0 1/217 (0.46%)  1 0/218 (0.00%)  0
lacunar infarction  1  1/218 (0.46%)  1 0/217 (0.00%)  0 0/218 (0.00%)  0
transient ischaemic attack  1  1/218 (0.46%)  1 0/217 (0.00%)  0 0/218 (0.00%)  0
Renal and urinary disorders       
nephrolithiasis  1  0/218 (0.00%)  0 0/217 (0.00%)  0 1/218 (0.46%)  1
obstructive uropathy  1  0/218 (0.00%)  0 1/217 (0.46%)  1 0/218 (0.00%)  0
renal failure acute  1  0/218 (0.00%)  0 0/217 (0.00%)  0 1/218 (0.46%)  1
Respiratory, thoracic and mediastinal disorders       
acute respiratory failure  1  0/218 (0.00%)  0 0/217 (0.00%)  0 1/218 (0.46%)  1
chronic obstructive pulmonary disease  1  4/218 (1.83%)  4 2/217 (0.92%)  2 2/218 (0.92%)  2
pleural effusion  1  1/218 (0.46%)  2 0/217 (0.00%)  0 0/218 (0.00%)  0
pulmonary hypertension  1  1/218 (0.46%)  1 0/217 (0.00%)  0 0/218 (0.00%)  0
respiratory failure  1  1/218 (0.46%)  1 0/217 (0.00%)  0 0/218 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID eFlow (CS) Nebulizer Placebo BID eFlow (CS) Nebulizer
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   37/218 (16.97%)      23/217 (10.60%)      38/218 (17.43%)    
Respiratory, thoracic and mediastinal disorders       
chronic obstructive ulmonary disease  1  19/218 (8.72%)  19 9/217 (4.15%)  9 17/218 (7.80%)  19
cough  1  21/218 (9.63%)  22 16/217 (7.37%)  20 22/218 (10.09%)  23
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Respiratory Medical Director
Organization: Sunovion Pharmaceuticals Inc.
Phone: 1-866-503-6351
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Responsible Party: Sunovion Respiratory Development Inc.
ClinicalTrials.gov Identifier: NCT02347761     History of Changes
Other Study ID Numbers: SUN101-301
First Submitted: January 21, 2015
First Posted: January 27, 2015
Results First Submitted: January 2, 2018
Results First Posted: March 22, 2018
Last Update Posted: March 22, 2018