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A Study of the Efficacy and Safety of EP-101 ( (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (GOLDEN-2)

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: NCT01706536
Recruitment Status : Completed
First Posted : October 15, 2012
Results First Posted : March 8, 2018
Last Update Posted : March 8, 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: Placebo
Drug: EP-101 12.5 mcg
Drug: EP-101 25 mcg
Drug: EP-101 50 mcg
Drug: EP-101 100 mcg
Enrollment 275
Recruitment Details  
Pre-assignment Details

Out of 302 subjects, 294 completed the run-in period. 12 out of 294 subjects completed the run-in period, but did not enter the double-blind period. Total of 282 subjects entered the double-blind period.

Specific details are outlined in the table below.

Arm/Group Title Placebo EP 101 12.5 mcg EP-101 25 mcg EP-101 50 mcg EP-101 100 mcg
Hide Arm/Group Description

Placebo AM + Placebo PM

Placebo:AM +Placebo PM

EP-101 12.5 mcg AM + EP-101 12.5 mcg PM

EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM

EP-101 25 mcg AM + EP-101 25 mcg PM

EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM

EP-101 50 mcg AM + EP-101 50 mcg PM

EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM

EP-101 100 mcg AM + EP-101 100 mcg PM

EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM

Period Title: Overall Study
Started 57 55 54 57 59
Completed 53 51 49 53 57
Not Completed 4 4 5 4 2
Reason Not Completed
Withdrawal by Subject             1             0             1             0             0
Adverse Event             2             3             4             3             2
Lack of Efficacy             1             0             0             1             0
non compliance             0             1             0             0             0
Arm/Group Title Placebo EP 101 12.5 mcg EP-101 25 mcg EP-101 50 mcg EP-101 100 mcg Total
Hide Arm/Group Description

Placebo AM + Placebo PM

Placebo:AM +Placebo PM

EP-101 12.5 mcg AM + EP-101 12.5 mcg PM

EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM

EP-101 25 mcg AM + EP-101 25 mcg PM

EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM

EP-101 50 mcg AM + EP-101 50 mcg PM

EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM

EP-101 100 mcg AM + EP-101 100 mcg PM

EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM

Total of all reporting groups
Overall Number of Baseline Participants 57 55 54 57 59 282
Hide Baseline Analysis Population Description
ITT population
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 55 participants 54 participants 57 participants 59 participants 282 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
30
  52.6%
36
  65.5%
40
  74.1%
36
  63.2%
42
  71.2%
184
  65.2%
>=65 years
27
  47.4%
19
  34.5%
14
  25.9%
21
  36.8%
17
  28.8%
98
  34.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 57 participants 55 participants 54 participants 57 participants 59 participants 282 participants
63.0  (7.29) 60.9  (7.79) 59.6  (8.98) 59.4  (8.70) 59.4  (7.65) 60.5  (8.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 55 participants 54 participants 57 participants 59 participants 282 participants
Female
31
  54.4%
28
  50.9%
30
  55.6%
24
  42.1%
34
  57.6%
147
  52.1%
Male
26
  45.6%
27
  49.1%
24
  44.4%
33
  57.9%
25
  42.4%
135
  47.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 55 participants 54 participants 57 participants 59 participants 282 participants
Hispanic or Latino
1
   1.8%
0
   0.0%
2
   3.7%
1
   1.8%
0
   0.0%
4
   1.4%
Not Hispanic or Latino
56
  98.2%
55
 100.0%
52
  96.3%
56
  98.2%
59
 100.0%
278
  98.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
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 57 participants 55 participants 54 participants 57 participants 59 participants 282 participants
American Indian or Alaska Native
1
   1.8%
0
   0.0%
0
   0.0%
1
   1.8%
0
   0.0%
2
   0.7%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
  12.3%
4
   7.3%
3
   5.6%
3
   5.3%
10
  16.9%
27
   9.6%
White
49
  86.0%
51
  92.7%
50
  92.6%
53
  93.0%
49
  83.1%
252
  89.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   1.9%
0
   0.0%
0
   0.0%
1
   0.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 57 participants 55 participants 54 participants 57 participants 59 participants 282 participants
57 55 54 57 59 282
1.Primary Outcome
Title Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1)
Hide Description Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Trough FEV1 was defined as the mean of the spirometry values collected at 23 hours 30 minutes and 24 hours after the in-clinic morning dose (i.e. approximately 12 hrs after the previous evening dose).
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication.
Arm/Group Title Placebo EP 101 12.5 mcg EP-101 25 mcg EP-101 50 mcg EP-101 100 mcg
Hide Arm/Group Description:

Placebo AM + Placebo PM

Placebo:AM +Placebo PM

EP-101 12.5 mcg AM + EP-101 12.5 mcg PM

EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM

EP-101 25 mcg AM + EP-101 25 mcg PM

EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM

EP-101 50 mcg AM + EP-101 50 mcg PM

EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM

EP-101 100 mcg AM + EP-101 100 mcg PM

EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM

Overall Number of Participants Analyzed 57 55 54 57 59
Mean (Standard Deviation)
Unit of Measure: liters
0.0009  (0.16664) 0.1055  (0.18013) 0.1333  (0.26526) 0.1336  (0.23813) 0.1794  (0.21678)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, EP 101 12.5 mcg
Comments A sample size of 45 subjects per treatment arm provides approximately 80% power to detect a 0.12 L treatment difference in mean change in trough FEV1 between an active arm and the placebo arm at a significance level of 0.05 using a 2-group t-test and assumes a standard deviation for change in trough FEV1 of 200. Assuming a 20% discontinuation rate, approximately 55 subjects were enrolled into each treatment arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0043
Comments [Not Specified]
Method Least squares mean (SE)
Comments In order to control for Type I error rate, a gate keeping methodology was used.
Method of Estimation Estimation Parameter Least Squares Mean (SE)
Estimated Value 0.1168
Confidence Interval (2-Sided) 95%
0.0369 to 0.1966
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.04055
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, EP-101 25 mcg
Comments A sample size of 45 subjects per treatment arm provides approximately 80% power to detect a 0.12 L treatment difference in mean change in trough FEV1 between an active arm and the placebo arm at a significance level of 0.05 using a 2-group t-test and assumes a standard deviation for change in trough FEV1 of 200. Assuming a 20% discontinuation rate, approximately 55 subjects were enrolled into each treatment arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0019
Comments In order to control for Type I error rate, a gate keeping methodology was used
Method Least squares mean (SE)
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean (SE)
Estimated Value 0.1284
Confidence Interval (2-Sided) 95%
0.0479 to 0.2089
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.04089
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, EP-101 50 mcg
Comments A sample size of 45 subjects per treatment arm provides approximately 80% power to detect a 0.12 L treatment difference in mean change in trough FEV1 between an active arm and the placebo arm at a significance level of 0.05 using a 2-group t-test and assumes a standard deviation for change in trough FEV1 of 200. Assuming a 20% discontinuation rate, approximately 55 subjects were enrolled into each treatment arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments in order to control for Type 1 error rate, a gate keeping methodology was used
Method Least squares mean (SE)
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean (SE)
Estimated Value 0.1462
Confidence Interval (2-Sided) 95%
0.0667 to 0.2257
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.04037
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection EP-101 100 mcg
Comments A sample size of 45 subjects per treatment arm provides approximately 80% power to detect a 0.12 L treatment difference in mean change in trough FEV1 between an active arm and the placebo arm at a significance level of 0.05 using a 2-group t-test and assumes a standard deviation for change in trough FEV1 of 200. Assuming a 20% discontinuation rate, approximately 55 subjects were enrolled into each treatment arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments in order to control for type I error rate, a gate keeping methodology was used
Method Least squares mean (SE)
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean (SE)
Estimated Value 0.1770
Confidence Interval (2-Sided) 95%
0.0992 to 0.2548
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.03953
Estimation Comments [Not Specified]
2.Secondary Outcome
Title The Standardized Change From Baseline FEV1 AUC(0-12)
Hide Description Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication.
Arm/Group Title Placebo EP 101 12.5 mcg EP-101 25 mcg EP-101 50 mcg EP-101 100 mcg
Hide Arm/Group Description:

Placebo AM + Placebo PM

Placebo AM + Placebo PM

EP-101 12.5 mcg AM + EP-101 12.5 mcg PM

EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM

EP-101 25 mcg AM + EP-101 25 mcg PM

EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM

EP-101 50 mcg AM + EP-101 50 mcg PM

EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM

EP-101 100 mcg AM + EP-101 100 mcg PM

EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM

Overall Number of Participants Analyzed 57 55 5 57 59
Mean (Standard Deviation)
Unit of Measure: liters
0.0055  (0.15426) 0.1370  (0.17082) 0.1720  (0.24720) 0.1066  (0.20512) 0.1815  (0.18544)
3.Secondary Outcome
Title The Standardized Change From Baseline FEV1 AUC(12-24)
Hide Description Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
A substudy of subjects in the ITT population consisted of subjects who were randomized to treatment and received at least 1 dose of double-blind study medication and who had extended spirometry measurements.
Arm/Group Title Placebo EP 101 12.5 mcg EP-101 25 mcg EP-101 50 mcg EP-101 100 mcg
Hide Arm/Group Description:

Placebo AM + Placebo PM

Placebo:AM +Placebo PM

EP-101 12.5 mcg AM + EP-101 12.5 mcg PM

EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM

EP-101 25 mcg AM + EP-101 25 mcg PM

EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM

EP-101 50 mcg AM + EP-101 50 mcg PM

EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM

EP-101 100 mcg AM + EP-101 100 mcg PM

EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM

Overall Number of Participants Analyzed 24 26 24 25 26
Mean (Standard Deviation)
Unit of Measure: liters
-0.0725  (0.16509) 0.0578  (0.14054) 0.0563  (0.27985) 0.0692  (0.19252) 0.1284  (0.21688)
4.Secondary Outcome
Title The Peak FEV1 Change From Baseline
Hide Description Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Peak FEV1 is defined as the highest postdose FEV1 value within 4 hrs after the morning dose.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication.
Arm/Group Title Placebo EP 101 12.5 mcg EP-101 25 mcg EP-101 50 mcg EP-101 100 mcg
Hide Arm/Group Description:

Placebo AM + Placebo PM

Placebo:AM +Placebo PM

EP-101 12.5 mcg AM + EP-101 12.5 mcg PM

EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM

EP-101 25 mcg AM + EP-101 25 mcg PM

EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM

EP-101 50 mcg AM + EP-101 50 mcg PM

EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM

EP-101 100 mcg AM + EP-101 100 mcg PM

EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM

Overall Number of Participants Analyzed 55 54 54 57 59
Mean (Standard Deviation)
Unit of Measure: liters
0.0931  (0.17808) 0.2613  (0.18782) 002960  (.0026303) 0.2552  (0.22395) 0.3165  (0.21409)
5.Secondary Outcome
Title The Number of Subjects With Treatment-emergent Adverse Events
Hide Description Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
Time Frame Baseline up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication. Safety analyses were performed using the actual drug a subject received.
Arm/Group Title Placebo EP 101 12.5 mcg EP-101 25 mcg EP-101 50 mcg EP-101 100 mcg
Hide Arm/Group Description:

Placebo AM + Placebo PM

Placebo:AM +Placebo PM

EP-101 12.5 mcg AM + EP-101 12.5 mcg PM

EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM

EP-101 25 mcg AM + EP-101 25 mcg PM

EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM

EP-101 50 mcg AM + EP-101 50 mcg PM

EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM

EP-101 100 mcg AM + EP-101 100 mcg PM

EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM

Overall Number of Participants Analyzed 57 55 54 57 59
Measure Type: Number
Unit of Measure: participants
15 19 18 18 17
6.Secondary Outcome
Title The Number of Subjects With Treatment-emergent Serious Adverse Events
Hide Description Treatment-emergent serious adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
Time Frame Baseline up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication. Safety analyses were performed using the actual drug a subject received.
Arm/Group Title Placebo EP 101 12.5 mcg EP-101 25 mcg EP-101 50 mcg EP-101 100 mcg
Hide Arm/Group Description:

Placebo AM + Placebo PM

Placebo:AM +Placebo PM

EP-101 12.5 mcg AM + EP-101 12.5 mcg PM

EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM

EP-101 25 mcg AM + EP-101 25 mcg PM

EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM

EP-101 50 mcg AM + EP-101 50 mcg PM

EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM

EP-101 100 mcg AM + EP-101 100 mcg PM

EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM

Overall Number of Participants Analyzed 57 55 54 57 59
Measure Type: Number
Unit of Measure: participants
2 2 2 1 3
7.Secondary Outcome
Title The Number of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation
Hide Description Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
Time Frame Baseline up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication. Safety analyses were performed using the actual drug a subject received.
Arm/Group Title Placebo EP 101 12.5 mcg EP-101 25 mcg EP-101 50 mcg EP-101 100 mcg
Hide Arm/Group Description:

Placebo AM + Placebo PM

Placebo:AM +Placebo PM

EP-101 12.5 mcg AM + EP-101 12.5 mcg PM

EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM

EP-101 25 mcg AM + EP-101 25 mcg PM

EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM

EP-101 50 mcg AM + EP-101 50 mcg PM

EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM

EP-101 100 mcg AM + EP-101 100 mcg PM

EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM

Overall Number of Participants Analyzed 57 55 54 57 59
Measure Type: Number
Unit of Measure: participants
2 3 4 3 1
8.Secondary Outcome
Title The Percentage of Subjects With Treatment-emergent Adverse Events
Hide Description Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
Time Frame Baseline up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication. Safety analyses were performed using the actual drug a subject received.
Arm/Group Title Placebo EP 101 12.5 mcg EP-101 25 mcg EP-101 50 mcg EP-101 100 mcg
Hide Arm/Group Description:

Placebo AM + Placebo PM

Placebo:AM +Placebo PM

EP-101 12.5 mcg AM + EP-101 12.5 mcg PM

EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM

EP-101 25 mcg AM + EP-101 25 mcg PM

EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM

EP-101 50 mcg AM + EP-101 50 mcg PM

EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM

EP-101 100 mcg AM + EP-101 100 mcg PM

EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM

Overall Number of Participants Analyzed 57 55 54 57 59
Measure Type: Number
Unit of Measure: percentage of participants
26.3 34.5 33.3 31.6 28.8
9.Secondary Outcome
Title The Percentage of Subjects With Treatment-emergent Serious Adverse Events
Hide Description Treatment-emergent serious adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
Time Frame Baseline up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication. Safety analyses were performed using the actual drug a subject received.
Arm/Group Title Placebo EP 101 12.5 mcg EP-101 25 mcg EP-101 50 mcg EP-101 100 mcg
Hide Arm/Group Description:

Placebo AM + Placebo PM

Placebo:AM +Placebo PM

EP-101 12.5 mcg AM + EP-101 12.5 mcg PM

EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM

EP-101 25 mcg AM + EP-101 25 mcg PM

EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM

EP-101 50 mcg AM + EP-101 50 mcg PM

EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM

EP-101 100 mcg AM + EP-101 100 mcg PM

EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM

Overall Number of Participants Analyzed 57 55 54 57 59
Measure Type: Number
Unit of Measure: percentage of participants
3.5 3.6 3.7 1.8 5.1
10.Secondary Outcome
Title The Percentage of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation
Hide Description Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
Time Frame Baseline up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication. Safety analyses were performed using the actual drug a subject received.
Arm/Group Title Placebo EP 101 12.5 mcg EP-101 25 mcg EP-101 50 mcg EP-101 100 mcg
Hide Arm/Group Description:

Placebo AM + Placebo PM

Placebo:AM +Placebo PM

EP-101 12.5 mcg AM + EP-101 12.5 mcg PM

EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM

EP-101 25 mcg AM + EP-101 25 mcg PM

EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM

EP-101 50 mcg AM + EP-101 50 mcg PM

EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM

EP-101 100 mcg AM + EP-101 100 mcg PM

EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM

Overall Number of Participants Analyzed 57 55 54 57 59
Measure Type: Number
Unit of Measure: percentage of participants
3.5 5.5 7.4 5.3 1.7
Time Frame Baseline up to Day 28
Adverse Event Reporting Description SAEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
 
Arm/Group Title Placebo EP 101 12.5 mcg EP-101 25 mcg EP-101 50 mcg EP-101 100 mcg
Hide Arm/Group Description

Placebo AM + Placebo PM

Placebo AM + Placebo PM

EP-101 12.5 mcg AM + EP-101 12.5 mcg PM

EP-101 12.5 mcg: EP-101 12.5 mcg AM + EP-101 12.5 mcg PM

EP-101 25 mcg AM + EP-101 25 mcg PM

EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM

EP-101 50 mcg AM + EP-101 50 mcg PM

EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM

EP-101 100 mcg AM + EP-101 100 mcg PM

EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM

All-Cause Mortality
Placebo EP 101 12.5 mcg EP-101 25 mcg EP-101 50 mcg EP-101 100 mcg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo EP 101 12.5 mcg EP-101 25 mcg EP-101 50 mcg EP-101 100 mcg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/57 (1.75%)      2/55 (3.64%)      2/54 (3.70%)      0/57 (0.00%)      1/59 (1.69%)    
Gastrointestinal disorders           
pancreatitis acute  1  0/57 (0.00%)  0 0/55 (0.00%)  0 1/54 (1.85%)  1 0/57 (0.00%)  0 0/59 (0.00%)  0
General disorders           
non-cardiac chest pain  1  0/57 (0.00%)  0 0/55 (0.00%)  0 0/54 (0.00%)  0 0/57 (0.00%)  0 1/59 (1.69%)  1
Infections and infestations           
bronchitis  1  0/57 (0.00%)  0 1/55 (1.82%)  1 0/54 (0.00%)  0 0/57 (0.00%)  0 0/59 (0.00%)  0
Injury, poisoning and procedural complications           
accidental overdose  1  0/57 (0.00%)  0 1/55 (1.82%)  1 0/54 (0.00%)  0 0/57 (0.00%)  0 0/59 (0.00%)  0
Investigations           
blood pressure increased  1  0/57 (0.00%)  0 0/55 (0.00%)  0 1/54 (1.85%)  1 0/57 (0.00%)  0 0/59 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
lung neoplasm malignant  1  1/57 (1.75%)  1 0/55 (0.00%)  0 0/54 (0.00%)  0 0/57 (0.00%)  0 0/59 (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%
Placebo EP 101 12.5 mcg EP-101 25 mcg EP-101 50 mcg EP-101 100 mcg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/57 (5.26%)      2/55 (3.64%)      5/54 (9.26%)      3/57 (5.26%)      6/59 (10.17%)    
Gastrointestinal disorders           
Diarrhoea  1  2/57 (3.51%)  2 0/55 (0.00%)  0 0/54 (0.00%)  0 0/57 (0.00%)  0 3/59 (5.08%)  3
Nervous system disorders           
headache  1  1/57 (1.75%)  1 0/55 (0.00%)  0 2/54 (3.70%)  2 2/57 (3.51%)  2 3/59 (5.08%)  3
Respiratory, thoracic and mediastinal disorders           
Chronic Obstructive Pulmonary Disease  1  0/57 (0.00%)  0 2/55 (3.64%)  2 3/54 (5.56%)  3 1/57 (1.75%)  1 0/59 (0.00%)  0
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 the 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
EMail: clinicaltrialsdisclosure@sunovion.com
Layout table for additonal information
Responsible Party: Sunovion Respiratory Development Inc.
ClinicalTrials.gov Identifier: NCT01706536     History of Changes
Other Study ID Numbers: EP-101-04 (SUN101)
First Submitted: October 10, 2012
First Posted: October 15, 2012
Results First Submitted: January 2, 2018
Results First Posted: March 8, 2018
Last Update Posted: March 8, 2018