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Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD (GOLDEN-4) (GOLDEN-4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02347774
Recruitment Status : Completed
First Posted : January 27, 2015
Results First Posted : March 13, 2018
Last Update Posted : March 13, 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
Conditions COPD
Chronic Obstructive Pulmonary Disease
Interventions Drug: SUN-101 50 mcg BID eFlow (CS) nebulizer
Drug: SUN-101 25 mcg BID eFlow (CS) nebulizer
Drug: Placebo eFlow (CS) nebulizer
Enrollment 641
Recruitment Details  
Pre-assignment Details

All enrolled were randomized. All subjects were to be followed for the full 12-week treatment period of the study, whether or not they continued on the study drug, .until the end of the treatment period.

One subject randomized in error to the placebo arm was never dosed .

Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID e-Flow (CS) Nebulizer Placebo BID Eflow (CS) Nebulizer
Hide Arm/Group Description

SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer

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

SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer

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

Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer

Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer

Period Title: Study Participation
Started 214 214 213 [1]
Completed 199 193 188
Not Completed 15 21 25
Reason Not Completed
Lost to Follow-up             3             6             2
Withdrawal by Subject             8             9             15
Adverse Event             1             4             6
withdrew consent             1             1             1
Met Prolonged QT criteria             1             0             0
non-compliance with study drug             0             1             0
incarceration             1             0             0
randomized in error             0             0             1
[1]
One subject randomized in error to the placebo arm was never dosed .
Period Title: On Study Treatment
Started 214 214 213 [1]
Completed 190 183 177
Not Completed 24 31 36
Reason Not Completed
Adverse Event             9             15             19
Lack of Efficacy             3             0             2
non-complicance with study medication             0             2             0
Protocol Violation             0             0             1
withdrew consent             9             8             12
Lost to Follow-up             2             6             1
Met Prolonged QT criteria             1             0             0
ranomized in error             0             0             1
[1]
One subject randomized in error to the placebo arm was never dosed .
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID e-Flow (CS) Nebulizer Placebo BID Eflow (CS) Nebulizer Total
Hide Arm/Group Description

SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer

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

SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer

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

Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer

Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer

Total of all reporting groups
Overall Number of Baseline Participants 214 214 212 640
Hide Baseline Analysis Population Description
As noted in the participant flow section, One subject randomized in error to the placebo arm was never dosed .
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 214 participants 214 participants 212 participants 640 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
119
  55.6%
109
  50.9%
111
  52.4%
339
  53.0%
>=65 years
95
  44.4%
105
  49.1%
101
  47.6%
301
  47.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 214 participants 214 participants 212 participants 640 participants
62.6  (9.20) 63.6  (8.66) 63.7  (9.26) 63.3  (9.04)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 214 participants 214 participants 212 participants 640 participants
Female
87
  40.7%
90
  42.1%
88
  41.5%
265
  41.4%
Male
127
  59.3%
124
  57.9%
124
  58.5%
375
  58.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 214 participants 214 participants 212 participants 640 participants
Hispanic or Latino
3
   1.4%
2
   0.9%
3
   1.4%
8
   1.3%
Not Hispanic or Latino
211
  98.6%
212
  99.1%
209
  98.6%
632
  98.8%
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 214 participants 214 participants 212 participants 640 participants
American Indian or Alaska Native
0
   0.0%
1
   0.5%
0
   0.0%
1
   0.2%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   0.5%
1
   0.2%
Black or African American
26
  12.1%
27
  12.6%
19
   9.0%
72
  11.3%
White
188
  87.9%
185
  86.4%
192
  90.6%
565
  88.3%
More than one race
0
   0.0%
1
   0.5%
0
   0.0%
1
   0.2%
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 214 participants 214 participants 212 participants 640 participants
214 214 212 640
Cardiovascular risk (low/high) and categories for high cardiovascular risk  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 214 participants 214 participants 212 participants 640 participants
low cardiovascular risk 80 78 76 234
high cardiovascular risk 134 136 136 406
ischemic heart disease 20 24 20 64
cerebrovascular disease 10 8 9 27
peripheral arterial disease 7 9 17 33
clinically significant arrhythmia 8 7 6 19
heart failure 4 4 6 14
hypertension 124 123 125 372
Background long-acting beta(2) agonist (LABA) use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 214 participants 214 participants 212 participants 640 participants
background LABA use = yes 67 69 69 205
background LABA use = no 147 145 143 435
Forced expiratory volume in one second (FEV1)  
Least Squares Mean (Standard Deviation)
Unit of measure:  Liters
Number Analyzed 214 participants 214 participants 212 participants 640 participants
1.3506  (0.55380) 1.3232  (0.50179) 1.13355  (0.48612) 1.3365  (0.51414)
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.

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).

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.One subject randomized in error to the placebo arm was never dosed .
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID e-Flow (CS) Nebulizer Placebo BID Eflow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer

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

SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer

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

Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer

Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer

Overall Number of Participants Analyzed 214 214 212
Least Squares Mean (Standard Error)
Unit of Measure: liters
0.0847  (0.01423) 0.0921  (0.01446) 0.0111  (0.01452)
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 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 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 0.0002
Comments [Not Specified]
Method Least Mean Squared (SE)
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Mean Squared (SE)
Estimated Value 0.0736
Confidence Interval (2-Sided) 95%
0.0346 to 0.1127
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.01989
Estimation 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.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SUN-101 25 mcg BID e-Flow (CS) Nebulizer, Placebo BID Eflow (CS) Nebulizer
Comments The change from baseline in trough FEV1 was analyzed using a 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 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 [Not Specified]
Method Least Mean Squared (SE)
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Mean Squared (SE)
Estimated Value 0.0810
Confidence Interval (2-Sided) 95%
0.0416 to 0.1204
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02006
Estimation 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.
2.Primary Outcome
Title Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) Week 12
Hide Description

On-treatment 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.

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 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 e-Flow (CS) Nebulizer Placebo BID Eflow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer

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

SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer

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

Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer

Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer

Overall Number of Participants Analyzed 214 214 212
Least Squares Mean (Standard Error)
Unit of Measure: liters
0.0890  (0.01479) 0.0909  (0.01492) 0.0069  (0.01502)
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 repeated measures model 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 Mean Squared (SE)
Comments I
Method of Estimation Estimation Parameter Least Mean Squared (SE)
Estimated Value 0.0820
Confidence Interval (2-Sided) 95%
0.0417 to 0.1224
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02055
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SUN-101 25 mcg BID e-Flow (CS) Nebulizer, Placebo BID Eflow (CS) Nebulizer
Comments The change from baseline in trough FEV1 was analyzed using a mixed model repeated measures model 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 Mean Squared (SE)
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Mean Squared (SE)
Estimated Value 0.0840
Confidence Interval (2-Sided) 95%
0.0433 to 0.1246
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02069
Estimation Comments [Not Specified]
3.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 (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. One subject randomized in error to the placebo arm was never dosed .
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID e-Flow (CS) Nebulizer Placebo BID Eflow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer

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

SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer

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

Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer

Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer

Overall Number of Participants Analyzed 214 214 212
Least Squares Mean (Standard Error)
Unit of Measure: liters
0.1090  (0.02205) 0.1346  (0.2239) 0.0156  (0.02247)
4.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.

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. One subject randomized in error to the placebo arm was never dosed .
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID e-Flow (CS) Nebulizer Placebo BID Eflow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer

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

SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer

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

Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer

Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer

Overall Number of Participants Analyzed 214 214 212
Least Squares Mean (Standard Error)
Unit of Measure: liters
0.1210  (0.02332) 0.1385  (0.02354) 0.0084  (0.02367)
5.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.One subject randomized in error to the placebo arm was never dosed .
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID e-Flow (CS) Nebulizer Placebo BID Eflow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer

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

SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer

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

Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer

Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer

Overall Number of Participants Analyzed 214 214 212
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.825  (0.8060) -3.225  (0.8168) -0.138  (0.8067)
6.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.One subject randomized in error to the placebo arm was never dosed .
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID e-Flow (CS) Nebulizer Placebo BID Eflow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer

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

SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer

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

Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer

Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer

Overall Number of Participants Analyzed 214 214 212
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.609  (0.8237) -3.637  (0.8269) -0.052  (0.8212)
7.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 One subject randomized in error to the placebo arm was never dosed .

medication. Subjects were analyzed based on the treatment they were randomized to.One subject randomized in error to the placebo arm was never dosed .

Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID e-Flow (CS) Nebulizer Placebo BID Eflow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer

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

SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer

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

Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer

Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer

Overall Number of Participants Analyzed 214 214 212
Least Squares Mean (Standard Error)
Unit of Measure: puffs (medication used)
-0.845  (0.1311) -0.959  (0.1310) -0.678  (0.1339)
8.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.One subject randomized in error to the placebo arm was never dosed .
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID e-Flow (CS) Nebulizer Placebo BID Eflow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer

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

SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer

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

Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer

Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer

Overall Number of Participants Analyzed 214 214 212
Measure Type: Count of Participants
Unit of Measure: Participants
114 101 111
9.Secondary Outcome
Title Percentage of Subjects With Treatment Emergent Adverse Events (TEAE)
Hide Description 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. One subject randomized in error to the placebo arm was never dosed .
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID e-Flow (CS) Nebulizer Placebo BID Eflow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer

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

SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer

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

Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer

Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer

Overall Number of Participants Analyzed 214 214 212
Measure Type: Number
Unit of Measure: percentage of participants
53.3 47.2 52.4
10.Secondary Outcome
Title Number of Subjects With Treatment Emergent Serious Adverse Events (SAE)
Hide 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 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. One subject randomized in error to the placebo arm was never dosed .
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID e-Flow (CS) Nebulizer Placebo BID Eflow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer

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

SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer

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

Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer

Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer

Overall Number of Participants Analyzed 214 214 212
Measure Type: Count of Participants
Unit of Measure: Participants
8 5 13
11.Secondary Outcome
Title Percentage of Subjects With Treatment Emergent Serious Adverse Events (SAE)
Hide 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 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. One subject randomized in error to the placebo arm was never dosed .
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID e-Flow (CS) Nebulizer Placebo BID Eflow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer

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

SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer

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

Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer

Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer

Overall Number of Participants Analyzed 214 214 212
Measure Type: Number
Unit of Measure: percentage of participants
3.7 2.3 6.1
12.Secondary Outcome
Title Number of Subjects Who Discontinue Treatment Due to TEAE
Hide Description 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 medication. One subject randomized in error to the placebo arm was never dosed .
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID e-Flow (CS) Nebulizer Placebo BID Eflow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer

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

SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer

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

Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer

Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer

Overall Number of Participants Analyzed 214 214 212
Measure Type: Count of Participants
Unit of Measure: Participants
9 15 19
13.Secondary Outcome
Title Percentage of Subjects Who Discontinue Treatment Due to TEAE
Hide Description 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 medication. One subject randomized in error to the placebo arm was never dosed .
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID e-Flow (CS) Nebulizer Placebo BID Eflow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer

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

SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer

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

Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer

Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer

Overall Number of Participants Analyzed 214 214 212
Measure Type: Number
Unit of Measure: percentage of participants
4.2 7.0 9.0
14.Secondary Outcome
Title Number of Subjects With Major Adverse Cardiac Events (MACE)
Hide Description 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. One subject randomized in error to the placebo arm was never dosed .
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID e-Flow (CS) Nebulizer Placebo BID Eflow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer

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

SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer

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

Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer

Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer

Overall Number of Participants Analyzed 214 214 212
Measure Type: Count of Participants
Unit of Measure: Participants
MACE score 0 0 0
cardiovascular death 0 0 0
non-fatal myocardial infarction 0 0 0
non-fatal stroke 0 0 0
15.Secondary Outcome
Title Percentage of Subjects With Major Adverse Cardiac Events (MACE)
Hide Description 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.One subject randomized in error to the placebo arm was never dosed .
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID e-Flow (CS) Nebulizer Placebo BID Eflow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer

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

SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer

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

Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer

Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer

Overall Number of Participants Analyzed 214 214 212
Measure Type: Number
Unit of Measure: percentage of participants
MACE score 0 0 0.9
cardiovascular death 0 0 0
non-fatal myocardialinfarction 0 0 0.9
non-fatal stroke 0 0 0
16.Secondary Outcome
Title Incidence Rate Per 1000 Person-years of Subjects With Major Adverse Cardiac Events (MACE)
Hide Description

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)

Incidence 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.One subject randomized in error to the placebo arm was never dosed .
Arm/Group Title SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID e-Flow (CS) Nebulizer Placebo BID Eflow (CS) Nebulizer
Hide Arm/Group Description:

SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer

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

SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer

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

Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer

Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer

Overall Number of Participants Analyzed 214 214 212
Measure Type: Number
Unit of Measure: incidence rate
64.6 63.0 62.2
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 dose 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 e-Flow (CS) Nebulizer Placebo BID Eflow (CS) Nebulizer
Hide Arm/Group Description

SUN-101 50 mcg Twice Daily (BID) via e-Flow (R) Closed System (CS) nebulizer

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

SUN-101 25 mcg (BID) via e-Flow (R) Closed System (CS) nebulizer

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

Placebo (BID) via e-Flow (R) Closed System (CS) nebulizer

Placebo eFlow (CS) nebulizer: Placebo BID eFlow (R) Closed System (CS) nebulizer

All-Cause Mortality
SUN-101 50 mcg BID eFlow (CS) Nebulizer SUN-101 25 mcg BID e-Flow (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 e-Flow (CS) Nebulizer Placebo BID Eflow (CS) Nebulizer
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/214 (3.74%)      5/214 (2.34%)      13/212 (6.13%)    
Blood and lymphatic system disorders       
haemorrhagic anaemia  1  0/214 (0.00%)  0 0/214 (0.00%)  0 1/212 (0.47%)  1
Cardiac disorders       
acute myocardial infarction  1  0/214 (0.00%)  0 0/214 (0.00%)  0 1/212 (0.47%)  1
artiral fibrillation  1  0/214 (0.00%)  0 0/214 (0.00%)  0 2/212 (0.94%)  2
artiral flutter  1  0/214 (0.00%)  0 0/214 (0.00%)  0 1/212 (0.47%)  1
cardiomyoathy  1  0/214 (0.00%)  0 0/214 (0.00%)  0 1/212 (0.47%)  1
ventricular tachycardia  1  0/214 (0.00%)  0 0/214 (0.00%)  0 1/212 (0.47%)  1
Ear and labyrinth disorders       
vertigo  1  0/214 (0.00%)  0 1/214 (0.47%)  1 0/212 (0.00%)  0
Gastrointestinal disorders       
gastric ulcer  1  0/214 (0.00%)  0 0/214 (0.00%)  0 1/212 (0.47%)  1
gastrointestinal haemorrhage  1  0/214 (0.00%)  0 0/214 (0.00%)  0 1/212 (0.47%)  1
nausea  1  0/214 (0.00%)  0 1/214 (0.47%)  1 0/212 (0.00%)  0
pancreatitis necrotising  1  0/214 (0.00%)  0 0/214 (0.00%)  0 1/212 (0.47%)  1
General disorders       
asthenia  1  0/214 (0.00%)  0 1/214 (0.47%)  1 0/212 (0.00%)  0
non-cardiac chest pain  1  1/214 (0.47%)  1 0/214 (0.00%)  0 0/212 (0.00%)  0
Hepatobiliary disorders       
cholelithiasis  1  0/214 (0.00%)  0 0/214 (0.00%)  0 1/212 (0.47%)  1
Infections and infestations       
pneumonia  1  0/214 (0.00%)  0 0/214 (0.00%)  0 3/212 (1.42%)  4
Injury, poisoning and procedural complications       
chest injury  1  1/214 (0.47%)  1 0/214 (0.00%)  0 0/212 (0.00%)  0
coronary artery restenosis  1  0/214 (0.00%)  0 0/214 (0.00%)  0 1/212 (0.47%)  1
rib fracture  1  1/214 (0.47%)  1 0/214 (0.00%)  0 0/212 (0.00%)  0
Metabolism and nutrition disorders       
obesity  1  0/214 (0.00%)  0 1/214 (0.47%)  1 0/212 (0.00%)  0
Musculoskeletal and connective tissue disorders       
osteoarthritis  1  1/214 (0.47%)  1 0/214 (0.00%)  0 0/212 (0.00%)  0
Nervous system disorders       
carotid artery stenosis  1  0/214 (0.00%)  0 1/214 (0.47%)  2 1/212 (0.47%)  1
Renal and urinary disorders       
nephrolithiasis  1  2/214 (0.93%)  2 0/214 (0.00%)  0 0/212 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
bronchitis chronic  1  1/214 (0.47%)  1 0/214 (0.00%)  0 0/212 (0.00%)  0
chronic obstructive pulmonary disease  1  2/214 (0.93%)  2 0/214 (0.00%)  0 2/212 (0.94%)  2
Skin and subcutaneous tissue disorders       
hyperhidrosis  1  0/214 (0.00%)  0 1/214 (0.47%)  1 0/212 (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 e-Flow (CS) Nebulizer Placebo BID Eflow (CS) Nebulizer
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   41/214 (19.16%)      47/214 (21.96%)      39/212 (18.40%)    
Respiratory, thoracic and mediastinal disorders       
chronic obstructive pulmonary disease  1  12/214 (5.61%)  13 17/214 (7.94%)  17 17/212 (8.02%)  19
cough  1  18/214 (8.41%)  19 14/214 (6.54%)  14 14/212 (6.60%)  14
dyspnoea  1  11/214 (5.14%)  12 16/214 (7.48%)  16 8/212 (3.77%)  8
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
Layout table for additonal information
Responsible Party: Sunovion Respiratory Development Inc.
ClinicalTrials.gov Identifier: NCT02347774     History of Changes
Other Study ID Numbers: SUN101-302
First Submitted: January 21, 2015
First Posted: January 27, 2015
Results First Submitted: January 2, 2018
Results First Posted: March 13, 2018
Last Update Posted: March 13, 2018