Trial Outcomes & Findings for Study to Investigate the Dose Response, Safety and Efficacy of Nebulized EP-101(SUN101) in Patients With Chronic Obstructive Pulmonary Disease (COPD): GOLDEN-1 Study (NCT NCT01426009)
NCT ID: NCT01426009
Last Updated: 2018-05-09
Results Overview
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 post dose for Day 1 and Day 7 within each Treatment Period. Baseline was calculated as the mean of the FEV1 values at 45 minutes and 15 minutes prior to the morning dose at Day 1 of each Treatment Period. Change from baseline was calculated as the trough FEV1 value minus the baseline for Day 1 and Day 7.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
140 participants
Primary outcome timeframe
Day 1 and Day 7
Results posted on
2018-05-09
Participant Flow
One randomized subject did not receive any study medication.
Participant milestones
| Measure |
Total
total subjects which includes:EP-101 via nebulizer (eFlow®), Tiotropium bromide via (Spiriva® Handihaler®), Ipratropium bromide Inhalation Solution via Handihaler® DPI , and Placebo EP-101",
|
|---|---|
|
Period 1-First Intervention (7 Days)
STARTED
|
139
|
|
Period 1-First Intervention (7 Days)
EP-101 Via Nebulizer
|
23
|
|
Period 1-First Intervention (7 Days)
Ipratropium Bromide
|
23
|
|
Period 1-First Intervention (7 Days)
Placebo
|
24
|
|
Period 1-First Intervention (7 Days)
COMPLETED
|
137
|
|
Period 1-First Intervention (7 Days)
NOT COMPLETED
|
2
|
|
Washout 1
STARTED
|
137
|
|
Washout 1
COMPLETED
|
135
|
|
Washout 1
NOT COMPLETED
|
2
|
|
Period 2-Second Intervention (7 Days)
STARTED
|
135
|
|
Period 2-Second Intervention (7 Days)
EP-101 Via Nebulizer
|
23
|
|
Period 2-Second Intervention (7 Days)
Ipratropium Bromide
|
21
|
|
Period 2-Second Intervention (7 Days)
Placebo
|
21
|
|
Period 2-Second Intervention (7 Days)
COMPLETED
|
130
|
|
Period 2-Second Intervention (7 Days)
NOT COMPLETED
|
5
|
|
Washout 2
STARTED
|
130
|
|
Washout 2
COMPLETED
|
129
|
|
Washout 2
NOT COMPLETED
|
1
|
|
Period 3-Third Intervention (7 Days)
STARTED
|
129
|
|
Period 3-Third Intervention (7 Days)
EP-101 Via Nebulizer
|
20
|
|
Period 3-Third Intervention (7 Days)
Ipratropium Bromide
|
23
|
|
Period 3-Third Intervention (7 Days)
Placebo
|
22
|
|
Period 3-Third Intervention (7 Days)
COMPLETED
|
129
|
|
Period 3-Third Intervention (7 Days)
NOT COMPLETED
|
0
|
|
Washout 3
STARTED
|
129
|
|
Washout 3
COMPLETED
|
128
|
|
Washout 3
NOT COMPLETED
|
1
|
|
Period 4-Fourth Intervention (7 Days)
STARTED
|
128
|
|
Period 4-Fourth Intervention (7 Days)
EP-101 Via Nebulizer
|
9
|
|
Period 4-Fourth Intervention (7 Days)
Ipratropium Bromide
|
8
|
|
Period 4-Fourth Intervention (7 Days)
Tiotropium Bromide
|
76
|
|
Period 4-Fourth Intervention (7 Days)
Placebo
|
10
|
|
Period 4-Fourth Intervention (7 Days)
COMPLETED
|
127
|
|
Period 4-Fourth Intervention (7 Days)
NOT COMPLETED
|
1
|
|
Washout 4
STARTED
|
127
|
|
Washout 4
COMPLETED
|
126
|
|
Washout 4
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Total
total subjects which includes:EP-101 via nebulizer (eFlow®), Tiotropium bromide via (Spiriva® Handihaler®), Ipratropium bromide Inhalation Solution via Handihaler® DPI , and Placebo EP-101",
|
|---|---|
|
Period 1-First Intervention (7 Days)
Adverse Event
|
1
|
|
Period 1-First Intervention (7 Days)
Personal Reasons
|
1
|
|
Washout 1
Withdrawal by Subject
|
1
|
|
Washout 1
Personal Reasons
|
1
|
|
Period 2-Second Intervention (7 Days)
Adverse Event
|
4
|
|
Period 2-Second Intervention (7 Days)
personal reasons
|
1
|
|
Washout 2
electrive surgery
|
1
|
|
Washout 3
personal reasons
|
1
|
|
Period 4-Fourth Intervention (7 Days)
personal reasons
|
1
|
|
Washout 4
Lost to Follow-up
|
1
|
Baseline Characteristics
Study to Investigate the Dose Response, Safety and Efficacy of Nebulized EP-101(SUN101) in Patients With Chronic Obstructive Pulmonary Disease (COPD): GOLDEN-1 Study
Baseline characteristics by cohort
| Measure |
Total Particiants
n=139 Participants
total of all participants in the study
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
88 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
51 Participants
n=39 Participants
|
|
Age, Continuous
|
61.4 years
STANDARD_DEVIATION 8.11 • n=39 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
138 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
134 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
120 Participants
n=39 Participants
|
|
Region of Enrollment
United Kingdom
|
19 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 7Population: All subjects who received at least one dose of study medication and who had Day 1 pre-dose and Day 7 trough FEV1 values were included in the modified intent to treat analysis set
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 post dose for Day 1 and Day 7 within each Treatment Period. Baseline was calculated as the mean of the FEV1 values at 45 minutes and 15 minutes prior to the morning dose at Day 1 of each Treatment Period. Change from baseline was calculated as the trough FEV1 value minus the baseline for Day 1 and Day 7.
Outcome measures
| Measure |
EP-101 Via Nebulizer (eFlow®) 25 mcg
n=72 Participants
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
EP-101 Via Nebulizer (eFlow®) 50 mcg
n=75 Participants
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
EP-101 Via Nebulizer (eFlow®)100 mcg
n=75 Participants
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
EP-101 Via Nebulizer (eFlow®) 200 mcg
n=75 Participants
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
Ipratropium Bromide Inhalation Solution
n=72 Participants
Ipratropium bromide Inhalation Solution via Handihaler® DPI
Ipratropium bromide Inhalation Solution via Handihaler® DPI: Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer
|
Tiotropium Bromide Via (Spiriva® Handihaler®)
n=76 Participants
Tiotropium bromide via (Spiriva® Handihaler®)
Tiotropium bromide via (Spiriva® Handihaler®): Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI
|
Placebo
n=77 Participants
Placebo
Placebo : Placebo administered once daily for 7 days
|
|---|---|---|---|---|---|---|---|
|
Mean Change in 24 Post Dose Trough Forced Expiratory Volume in 1 Second (FEV1)
Trough FEV1 - day 1
|
0.0477 liters
Standard Deviation 0.16359
|
0.1009 liters
Standard Deviation 0.13261
|
0.0648 liters
Standard Deviation 0.14239
|
0.0632 liters
Standard Deviation 0.14965
|
0.0933 liters
Standard Deviation 0.18980
|
0.0740 liters
Standard Deviation 0.144441
|
0.0301 liters
Standard Deviation 0.14394
|
|
Mean Change in 24 Post Dose Trough Forced Expiratory Volume in 1 Second (FEV1)
Trough FEV1 - day 7
|
0.0478 liters
Standard Deviation 0.18965
|
0.0699 liters
Standard Deviation 0.16909
|
0.0666 liters
Standard Deviation 0.15132
|
0.0840 liters
Standard Deviation 0.13842
|
0.0292 liters
Standard Deviation 0.16507
|
0.0564 liters
Standard Deviation 0.16356
|
-0.155 liters
Standard Deviation 0.17934
|
PRIMARY outcome
Timeframe: Day 1 and Day 7Population: All subjects who received at least one dose of study medication and who had Day 1 pre-dose and Day 7 trough FEV1 values were included in the modified intent-to-treat (mITT) analysis set
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. The standardized FEV1 AUC(0-12hr and 12-24hr) on Day 1 and Day 7 was calculated using the trapezoidal rule from the changes in FEV1 at Day 1 and Day 7, respectively, from the baseline value (the mean of the two FEV1 values at 45 minutes and 15 minutes prior to morning dose at Day 1 of the respective Treatment Periods) and dividing by the actual length of the time interval.
Outcome measures
| Measure |
EP-101 Via Nebulizer (eFlow®) 25 mcg
n=72 Participants
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
EP-101 Via Nebulizer (eFlow®) 50 mcg
n=76 Participants
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
EP-101 Via Nebulizer (eFlow®)100 mcg
n=75 Participants
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
EP-101 Via Nebulizer (eFlow®) 200 mcg
n=71 Participants
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
Ipratropium Bromide Inhalation Solution
n=74 Participants
Ipratropium bromide Inhalation Solution via Handihaler® DPI
Ipratropium bromide Inhalation Solution via Handihaler® DPI: Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer
|
Tiotropium Bromide Via (Spiriva® Handihaler®)
n=75 Participants
Tiotropium bromide via (Spiriva® Handihaler®)
Tiotropium bromide via (Spiriva® Handihaler®): Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI
|
Placebo
n=76 Participants
Placebo
Placebo : Placebo administered once daily for 7 days
|
|---|---|---|---|---|---|---|---|
|
Standardized Change in FEV1 Area Under the Curve (AUC) (0-12hr , 12-24hr, 0-24hr) on Day 1 and Day 7
AUC 0-12 on Day 1
|
0.1001 liters
Standard Deviation 0.15704
|
0.1520 liters
Standard Deviation 0.13646
|
0.1414 liters
Standard Deviation 0.11045
|
0.1720 liters
Standard Deviation 0.12644
|
0.1990 liters
Standard Deviation 0.13740
|
0.1213 liters
Standard Deviation 0.12548
|
0.0130 liters
Standard Deviation 0.11486
|
|
Standardized Change in FEV1 Area Under the Curve (AUC) (0-12hr , 12-24hr, 0-24hr) on Day 1 and Day 7
AUC 12-24 on Day 1
|
0.0039 liters
Standard Deviation 0.17104
|
0.0681 liters
Standard Deviation 0.12835
|
0.0413 liters
Standard Deviation 0.14032
|
0.0645 liters
Standard Deviation 0.13275
|
0.0987 liters
Standard Deviation 0.16958
|
0.0499 liters
Standard Deviation 0.14532
|
-0.0245 liters
Standard Deviation 0.12151
|
|
Standardized Change in FEV1 Area Under the Curve (AUC) (0-12hr , 12-24hr, 0-24hr) on Day 1 and Day 7
AUC 0-24 on Day 1
|
0.0525 liters
Standard Deviation 0.15495
|
0.1107 liters
Standard Deviation 0.12207
|
0.0919 liters
Standard Deviation 0.11554
|
0.1194 liters
Standard Deviation 0.11905
|
0.1496 liters
Standard Deviation 0.14425
|
0.0872 liters
Standard Deviation 0.12638
|
-0.0073 liters
Standard Deviation 0.11377
|
|
Standardized Change in FEV1 Area Under the Curve (AUC) (0-12hr , 12-24hr, 0-24hr) on Day 1 and Day 7
AUC 0-12 on Day 7
|
0.1034 liters
Standard Deviation 0.19035
|
0.1411 liters
Standard Deviation 0.16343
|
0.1329 liters
Standard Deviation 0.13416
|
0.1438 liters
Standard Deviation 0.14833
|
0.1603 liters
Standard Deviation 0.16420
|
0.1256 liters
Standard Deviation 0.15197
|
-0.0098 liters
Standard Deviation 0.15537
|
|
Standardized Change in FEV1 Area Under the Curve (AUC) (0-12hr , 12-24hr, 0-24hr) on Day 1 and Day 7
AUC 12-24 on Day 7
|
0.0112 liters
Standard Deviation 0.18136
|
0.0540 liters
Standard Deviation 0.16633
|
0.0278 liters
Standard Deviation 0.15187
|
0.0614 liters
Standard Deviation 0.13450
|
0.0357 liters
Standard Deviation 0.17382
|
0.0283 liters
Standard Deviation 0.15596
|
0.0698 liters
Standard Deviation 0.16584
|
|
Standardized Change in FEV1 Area Under the Curve (AUC) (0-12hr , 12-24hr, 0-24hr) on Day 1 and Day 7
AUC 0-24 on Day 7
|
0.0579 liters
Standard Deviation 0.17822
|
0.0980 liters
Standard Deviation 0.15651
|
0.0812 liters
Standard Deviation 0.13293
|
0.1030 liters
Standard Deviation 0.13162
|
0.1009 liters
Standard Deviation 0.15882
|
0.0776 liters
Standard Deviation 0.14702
|
-0.0395 liters
Standard Deviation 0.15415
|
SECONDARY outcome
Timeframe: Day 1 and Day 7Population: All subjects who received at least one dose of study medication and who had Day 1 pre-dose and Day 7 trough FEV1 values were included in the modified intent-to-treat (mITT) analysis set
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines
Outcome measures
| Measure |
EP-101 Via Nebulizer (eFlow®) 25 mcg
n=72 Participants
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
EP-101 Via Nebulizer (eFlow®) 50 mcg
n=76 Participants
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
EP-101 Via Nebulizer (eFlow®)100 mcg
n=75 Participants
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
EP-101 Via Nebulizer (eFlow®) 200 mcg
n=72 Participants
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
Ipratropium Bromide Inhalation Solution
n=74 Participants
Ipratropium bromide Inhalation Solution via Handihaler® DPI
Ipratropium bromide Inhalation Solution via Handihaler® DPI: Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer
|
Tiotropium Bromide Via (Spiriva® Handihaler®)
n=76 Participants
Tiotropium bromide via (Spiriva® Handihaler®)
Tiotropium bromide via (Spiriva® Handihaler®): Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI
|
Placebo
n=77 Participants
Placebo
Placebo : Placebo administered once daily for 7 days
|
|---|---|---|---|---|---|---|---|
|
Peak FEV1 (Maximum FEV1 During the First 4 Hours Post-dose on Day 1 and Day 7)
Day 1
|
1.469 liters
Standard Deviation 0.5049
|
1.498 liters
Standard Deviation 0.4857
|
1.443 liters
Standard Deviation 0.4431
|
1.455 liters
Standard Deviation 0.4355
|
1.601 liters
Standard Deviation 0.4665
|
1.434 liters
Standard Deviation 0.4774
|
1.356 liters
Standard Deviation 0.4471
|
|
Peak FEV1 (Maximum FEV1 During the First 4 Hours Post-dose on Day 1 and Day 7)
Day 7
|
1.482 liters
Standard Deviation 0.4993
|
1.496 liters
Standard Deviation 0.4694
|
1.462 liters
Standard Deviation 0.4300
|
1.453 liters
Standard Deviation 0.4476
|
1.594 liters
Standard Deviation 0.4943
|
1.475 liters
Standard Deviation 0.4556
|
1.348 liters
Standard Deviation 0.4465
|
SECONDARY outcome
Timeframe: Day 1 and Day 7Population: All subjects who received at least one dose of study medication and who had Day 1 pre-dose and Day 7 through FEV1 values were included in the modified intent-to-treat (mITT) analysis set
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Clinically meaningful is defined as when the change from baseline (mean of the two pre-dose values at Day 1) in 24 hour trough FEV1 on a SUN-101 treatment is more than 100 mL compared to the mean change in trough FEV1 from all subjects on the placebo treatment.
Outcome measures
| Measure |
EP-101 Via Nebulizer (eFlow®) 25 mcg
n=72 Participants
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
EP-101 Via Nebulizer (eFlow®) 50 mcg
n=76 Participants
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
EP-101 Via Nebulizer (eFlow®)100 mcg
n=75 Participants
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
EP-101 Via Nebulizer (eFlow®) 200 mcg
n=72 Participants
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
Ipratropium Bromide Inhalation Solution
n=74 Participants
Ipratropium bromide Inhalation Solution via Handihaler® DPI
Ipratropium bromide Inhalation Solution via Handihaler® DPI: Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer
|
Tiotropium Bromide Via (Spiriva® Handihaler®)
n=76 Participants
Tiotropium bromide via (Spiriva® Handihaler®)
Tiotropium bromide via (Spiriva® Handihaler®): Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI
|
Placebo
Placebo
Placebo : Placebo administered once daily for 7 days
|
|---|---|---|---|---|---|---|---|
|
Treatment Responders (Number of Subjects With Clinically Meaningful Change From Pre-dose in Trough FEV1 on Day 1 and Day 7)
Day 1
|
18 number of participants
|
29 number of participants
|
24 number of participants
|
24 number of participants
|
24 number of participants
|
26 number of participants
|
—
|
|
Treatment Responders (Number of Subjects With Clinically Meaningful Change From Pre-dose in Trough FEV1 on Day 1 and Day 7)
Day 7
|
29 number of participants
|
30 number of participants
|
34 number of participants
|
37 number of participants
|
27 number of participants
|
37 number of participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 7Population: All subjects who received at least one dose of study medication were included in the safety analysis.
AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment. Vital signs were performed during the screening period to confirm study eligibility and at the final study visit. ECGs were performed during the screening period to confirm study eligibility. Vital signs and ECG were additionally collected within 30 minutes pre-dose; and 30 minutes, and 1, 2, 4, 6, 12 hours, and 23 hours 45 minutes post-dose within each treatment period. Clinical laboratory assessments were conducted during the screening period, at each study visit during each treatment period, and at the final study visit.
Outcome measures
| Measure |
EP-101 Via Nebulizer (eFlow®) 25 mcg
n=74 Participants
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
EP-101 Via Nebulizer (eFlow®) 50 mcg
n=78 Participants
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
EP-101 Via Nebulizer (eFlow®)100 mcg
n=76 Participants
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
EP-101 Via Nebulizer (eFlow®) 200 mcg
n=75 Participants
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
Ipratropium Bromide Inhalation Solution
n=75 Participants
Ipratropium bromide Inhalation Solution via Handihaler® DPI
Ipratropium bromide Inhalation Solution via Handihaler® DPI: Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer
|
Tiotropium Bromide Via (Spiriva® Handihaler®)
n=76 Participants
Tiotropium bromide via (Spiriva® Handihaler®)
Tiotropium bromide via (Spiriva® Handihaler®): Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI
|
Placebo
n=77 Participants
Placebo
Placebo : Placebo administered once daily for 7 days
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events, Vital Signs, and Clinically Significant Abnormal ECG Values and Laboratory Tests
Clinical signicant abnormal vital signs
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events, Vital Signs, and Clinically Significant Abnormal ECG Values and Laboratory Tests
Treatment emergent AEs
|
23 Participants
|
23 Participants
|
28 Participants
|
26 Participants
|
19 Participants
|
12 Participants
|
25 Participants
|
|
Number of Participants With Adverse Events, Vital Signs, and Clinically Significant Abnormal ECG Values and Laboratory Tests
Clinically significant abnormal ECG values Day 1
|
10 Participants
|
7 Participants
|
13 Participants
|
11 Participants
|
5 Participants
|
8 Participants
|
6 Participants
|
|
Number of Participants With Adverse Events, Vital Signs, and Clinically Significant Abnormal ECG Values and Laboratory Tests
Clinically significant abnormal ECG values Day 7
|
7 Participants
|
5 Participants
|
8 Participants
|
11 Participants
|
3 Participants
|
8 Participants
|
7 Participants
|
|
Number of Participants With Adverse Events, Vital Signs, and Clinically Significant Abnormal ECG Values and Laboratory Tests
Clinicall significant abnormal lab valuesday1-day7
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 7Population: All subjects who received at least one dose of study medication and who had Day 1 pre-dose and Day 7 through FEV1 values were included in the modified intent-to-treat (mITT) analysis set
Mean number of puffs of daily rescue medication
Outcome measures
| Measure |
EP-101 Via Nebulizer (eFlow®) 25 mcg
n=72 Participants
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
EP-101 Via Nebulizer (eFlow®) 50 mcg
n=76 Participants
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
EP-101 Via Nebulizer (eFlow®)100 mcg
n=75 Participants
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
EP-101 Via Nebulizer (eFlow®) 200 mcg
n=72 Participants
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
Ipratropium Bromide Inhalation Solution
n=74 Participants
Ipratropium bromide Inhalation Solution via Handihaler® DPI
Ipratropium bromide Inhalation Solution via Handihaler® DPI: Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer
|
Tiotropium Bromide Via (Spiriva® Handihaler®)
n=76 Participants
Tiotropium bromide via (Spiriva® Handihaler®)
Tiotropium bromide via (Spiriva® Handihaler®): Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI
|
Placebo
n=77 Participants
Placebo
Placebo : Placebo administered once daily for 7 days
|
|---|---|---|---|---|---|---|---|
|
Rescue Medication Use
|
1.34 average daily number of puffs
Standard Deviation 2.72
|
1.11 average daily number of puffs
Standard Deviation 1.89
|
1.48 average daily number of puffs
Standard Deviation 2.43
|
1.29 average daily number of puffs
Standard Deviation 2.70
|
1.42 average daily number of puffs
Standard Deviation 2.91
|
1.33 average daily number of puffs
Standard Deviation 3.01
|
1.59 average daily number of puffs
Standard Deviation 2.16
|
SECONDARY outcome
Timeframe: Day 1 and Day 7Population: All subjects who received at least one dose of study medication and who had Day 1 pre-dose and Day 7 through FEV1 values were included in the modified intent-to-treat (mITT) analysis set
percentage of subjects with clinically meaningful change from pre-dose in trough FEV1 on Day 1 and Day 7 Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
Outcome measures
| Measure |
EP-101 Via Nebulizer (eFlow®) 25 mcg
n=72 Participants
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
EP-101 Via Nebulizer (eFlow®) 50 mcg
n=76 Participants
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
EP-101 Via Nebulizer (eFlow®)100 mcg
n=75 Participants
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
EP-101 Via Nebulizer (eFlow®) 200 mcg
n=72 Participants
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
Ipratropium Bromide Inhalation Solution
n=74 Participants
Ipratropium bromide Inhalation Solution via Handihaler® DPI
Ipratropium bromide Inhalation Solution via Handihaler® DPI: Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer
|
Tiotropium Bromide Via (Spiriva® Handihaler®)
n=76 Participants
Tiotropium bromide via (Spiriva® Handihaler®)
Tiotropium bromide via (Spiriva® Handihaler®): Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI
|
Placebo
Placebo
Placebo : Placebo administered once daily for 7 days
|
|---|---|---|---|---|---|---|---|
|
Treatment Responders (Percentage of Subjects With Clinically Meaningful Change From Pre-dose in Trough FEV1 on Day 1 and Day 7)
Day 1
|
25.0 percentage of participants
|
38.7 percentage of participants
|
32.0 percentage of participants
|
35.3 percentage of participants
|
33.8 percentage of participants
|
34.7 percentage of participants
|
—
|
|
Treatment Responders (Percentage of Subjects With Clinically Meaningful Change From Pre-dose in Trough FEV1 on Day 1 and Day 7)
Day 7
|
40.3 percentage of participants
|
40.0 percentage of participants
|
46.6 percentage of participants
|
51.4 percentage of participants
|
37.5 percentage of participants
|
48.7 percentage of participants
|
—
|
Adverse Events
EP-101 Via Nebulizer (eFlow®) 25 mcg
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
EP-101 Via Nebulizer (eFlow®) 50 mcg
Serious events: 13 serious events
Other events: 0 other events
Deaths: 0 deaths
EP-101 Via Nebulizer (eFlow®)100 mcg
Serious events: 14 serious events
Other events: 0 other events
Deaths: 0 deaths
EP-101 Via Nebulizer (eFlow®) 200 mcg
Serious events: 13 serious events
Other events: 0 other events
Deaths: 0 deaths
Ipratropium Bromide Inhalation Solution
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Tiotropium Bromide Via (Spiriva® Handihaler®)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 16 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EP-101 Via Nebulizer (eFlow®) 25 mcg
n=74 participants at risk
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
EP-101 Via Nebulizer (eFlow®) 50 mcg
n=78 participants at risk
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
EP-101 Via Nebulizer (eFlow®)100 mcg
n=76 participants at risk
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
EP-101 Via Nebulizer (eFlow®) 200 mcg
n=75 participants at risk
EP-101 via nebulizer (eFlow®)
EP-101 via nebulizer (eFlow®): EP-101 Dose 1 administered once daily for 7 days
EP-101 via nebulizer (eFlow®): EP-101 administered once daily for 7 days
|
Ipratropium Bromide Inhalation Solution
n=75 participants at risk
Ipratropium bromide Inhalation Solution via Handihaler® DPI
Ipratropium bromide Inhalation Solution via Handihaler® DPI: Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer
|
Tiotropium Bromide Via (Spiriva® Handihaler®)
n=76 participants at risk
Tiotropium bromide via (Spiriva® Handihaler®)
Tiotropium bromide via (Spiriva® Handihaler®): Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI
|
Placebo
n=77 participants at risk
Placebo
Placebo : Placebo administered once daily for 7 days
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
headache
|
4.1%
3/74 • Number of events 4 • day 1 through day 7
existing conditions which worsen or events which occur during the course of the clinical trial after treatment with randomized study drug has started
|
3.8%
3/78 • Number of events 5 • day 1 through day 7
existing conditions which worsen or events which occur during the course of the clinical trial after treatment with randomized study drug has started
|
6.6%
5/76 • Number of events 5 • day 1 through day 7
existing conditions which worsen or events which occur during the course of the clinical trial after treatment with randomized study drug has started
|
5.3%
4/75 • Number of events 7 • day 1 through day 7
existing conditions which worsen or events which occur during the course of the clinical trial after treatment with randomized study drug has started
|
0.00%
0/75 • day 1 through day 7
existing conditions which worsen or events which occur during the course of the clinical trial after treatment with randomized study drug has started
|
2.6%
2/76 • Number of events 3 • day 1 through day 7
existing conditions which worsen or events which occur during the course of the clinical trial after treatment with randomized study drug has started
|
9.1%
7/77 • Number of events 9 • day 1 through day 7
existing conditions which worsen or events which occur during the course of the clinical trial after treatment with randomized study drug has started
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
6.8%
5/74 • Number of events 9 • day 1 through day 7
existing conditions which worsen or events which occur during the course of the clinical trial after treatment with randomized study drug has started
|
12.8%
10/78 • Number of events 13 • day 1 through day 7
existing conditions which worsen or events which occur during the course of the clinical trial after treatment with randomized study drug has started
|
11.8%
9/76 • Number of events 15 • day 1 through day 7
existing conditions which worsen or events which occur during the course of the clinical trial after treatment with randomized study drug has started
|
12.0%
9/75 • Number of events 14 • day 1 through day 7
existing conditions which worsen or events which occur during the course of the clinical trial after treatment with randomized study drug has started
|
6.7%
5/75 • Number of events 5 • day 1 through day 7
existing conditions which worsen or events which occur during the course of the clinical trial after treatment with randomized study drug has started
|
1.3%
1/76 • Number of events 1 • day 1 through day 7
existing conditions which worsen or events which occur during the course of the clinical trial after treatment with randomized study drug has started
|
11.7%
9/77 • Number of events 14 • day 1 through day 7
existing conditions which worsen or events which occur during the course of the clinical trial after treatment with randomized study drug has started
|
Other adverse events
Adverse event data not reported
Additional Information
Respiratory Medical Director
Sunovion Pharmaceuticals Inc.
Phone: 1-866-503-6351
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER