COPD
Conditions
Brief summary
This is a randomized, double-blind, placebo-controlled, parallel arm study. The study population will consist of subjects, 35 to 75 years of age, with a diagnosis of moderate to severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines.
Detailed description
This is a randomized, double-blind, placebo-controlled, parallel arm study. The study population will consist of subjects, 35 to 75 years of age, with a diagnosis of moderate to severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD, 2011). The primary analysis will compare each of the EP-101 (SUN101) dose groups to placebo with respect to the change from baseline in morning trough FEV1 on Day 29. Trough FEV1 is defined as the mean of the two FEV1 values obtained at 23 hours 30 minutes and 24 hours after Day 28 AM dose (ie, approximately 12 hours after the previous PM dose).
Interventions
DRUGPlacebo
EP-101 Placebo AM + EP-101 Placebo PM
DRUGEP-101 12.5 mcg
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
DRUGEP-101 25 mcg
EP-101 25 mcg AM + EP-101 25 mcg PM
DRUGEP-101 50 mcg
EP-101 50 mcg AM + EP-101 50 mcg PM
DRUGEP-101 100 mcg
EP-101 100 mcg AM + EP-101 100 mcg PM
Sponsors
Sunovion Respiratory Development Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male and female subjects age 35 through 75 years, inclusive. * A clinical diagnosis of moderate to severe COPD according to GOLD guidelines (2011). * Current smokers or ex-smokers with at least 10 pack-year smoking history (eg, at least 1 pack/day for 10 years, or equivalent). * Post-bronchodilator (following inhalation of ipratropium bromide MDI) FEV1 ≥ 30% and ≤ 70% of predicted normal value during the Screening Period. * Post-bronchodilator (following inhalation of ipratropium bromide MDI) FEV1/FVC ratio \< 0.70 during the Screening Period. * Post-bronchodilator (following inhalation of ipratropium bromide MDI) improvement in FEV1 ≥ 12% and ≥ 100 mL during the Screening Period. * Ability to perform reproducible spirometry according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines (2005). * Subject, if female ≤ 65 years of age and of child bearing potential, must have a negative serum pregnancy test at screening. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control: * a. An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following study participation. * b. Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study. * c. Abstinence. * Willing and able to provide written informed consent.
Exclusion criteria
* Current evidence or recent history of any clinically significant and unstable disease (other than COPD) or abnormality in the opinion of the Investigator that would put the subject at risk or which would compromise the quality of the study data; including but not limited to cardiovascular disease, myocardial infarction, cardiac failure, uncontrolled hypertension, life-threatening arrhythmias, uncontrolled diabetes, neurologic or neuromuscular disease, liver disease, gastrointestinal disease or electrolyte abnormalities. * Current evidence or history of clinically significant abnormal cardiac rhythm and/or conduction findings, including Holter monitoring results during the Screening Period. * Concomitant pulmonary disease or primary diagnosis of asthma. * History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localized basal cell carcinoma of the skin * Recent history of COPD exacerbation requiring hospitalization or need for increased treatments for COPD within 6 weeks prior to the Screening Period. * Use of daily oxygen therapy \> 10 hours per day. * Use of systemic steroids within 3 months prior to the Screening Period. * Respiratory tract infection within 6 weeks prior to or during the Screening Period. * History of tuberculosis, bronchiectasis or other non-specific pulmonary disease. * History of urinary retention or bladder neck obstruction type symptoms. * History of narrow-angle glaucoma. * Prolonged QTc interval (\> 450msec for males and \> 470msec for females) during the Screening Period, or history of long QT syndrome. * Recent history (previous 12 months) of excessive use or abuse of narcotic/illegal drugs. * History of hypersensitivity or intolerance to β2-agonists or anticholinergics. * Participation in another investigational drug study where drug was received within 30 days prior to the Screening Period. * Female subject who is pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) | Baseline and Day 29 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Standardized Change From Baseline FEV1 AUC(12-24) | Day 28 | Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. |
| The Peak FEV1 Change From Baseline | Day 28 | 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. |
| The Number of Subjects With Treatment-emergent Adverse Events | Baseline up to Day 28 | 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. |
| The Number of Subjects With Treatment-emergent Serious Adverse Events | Baseline up to Day 28 | 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. |
| The Standardized Change From Baseline FEV1 AUC(0-12) | Day 28 | Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. |
| The Percentage of Subjects With Treatment-emergent Adverse Events | Baseline up to Day 28 | 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. |
| The Percentage of Subjects With Treatment-emergent Serious Adverse Events | Baseline up to Day 28 | 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. |
| The Percentage of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation | Baseline up to Day 28 | 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. |
| The Number of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation | Baseline up to Day 28 | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo AM + Placebo PM
Placebo:AM +Placebo PM | 57 |
| EP 101 12.5 mcg 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 | 55 |
| EP-101 25 mcg EP-101 25 mcg AM + EP-101 25 mcg PM
EP-101 25 mcg: EP-101 25 mcg AM + EP-101 25 mcg PM | 54 |
| EP-101 50 mcg EP-101 50 mcg AM + EP-101 50 mcg PM
EP-101 50 mcg: EP-101 50 mcg AM + EP-101 50 mcg PM | 57 |
| EP-101 100 mcg EP-101 100 mcg AM + EP-101 100 mcg PM
EP-101 100 mcg: EP-101 100 mcg AM + EP-101 100 mcg PM | 59 |
| Total | 282 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 | 4 | 3 | 2 |
| Overall Study | Lack of Efficacy | 1 | 0 | 0 | 1 | 0 |
| Overall Study | non compliance | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | EP 101 12.5 mcg | EP-101 25 mcg | EP-101 50 mcg | EP-101 100 mcg | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 27 Participants | 19 Participants | 14 Participants | 21 Participants | 17 Participants | 98 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 36 Participants | 40 Participants | 36 Participants | 42 Participants | 184 Participants |
| Age, Continuous | 63.0 years STANDARD_DEVIATION 7.29 | 60.9 years STANDARD_DEVIATION 7.79 | 59.6 years STANDARD_DEVIATION 8.98 | 59.4 years STANDARD_DEVIATION 8.7 | 59.4 years STANDARD_DEVIATION 7.65 | 60.5 years STANDARD_DEVIATION 8.16 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants | 55 Participants | 52 Participants | 56 Participants | 59 Participants | 278 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 4 Participants | 3 Participants | 3 Participants | 10 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 49 Participants | 51 Participants | 50 Participants | 53 Participants | 49 Participants | 252 Participants |
| Region of Enrollment United States | 57 Participants | 55 Participants | 54 Participants | 57 Participants | 59 Participants | 282 Participants |
| Sex: Female, Male Female | 31 Participants | 28 Participants | 30 Participants | 24 Participants | 34 Participants | 147 Participants |
| Sex: Female, Male Male | 26 Participants | 27 Participants | 24 Participants | 33 Participants | 25 Participants | 135 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 57 | 2 / 55 | 5 / 54 | 3 / 57 | 6 / 59 |
| serious Total, serious adverse events | 1 / 57 | 2 / 55 | 2 / 54 | 0 / 57 | 1 / 59 |
Outcome results
Primary
Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1)
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
Population: The ITT population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) | 0.0009 liters | Standard Deviation 0.16664 |
| EP 101 12.5 mcg | Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) | 0.1055 liters | Standard Deviation 0.18013 |
| EP-101 25 mcg | Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) | 0.1333 liters | Standard Deviation 0.26526 |
| EP-101 50 mcg | Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) | 0.1336 liters | Standard Deviation 0.23813 |
| EP-101 100 mcg | Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) | 0.1794 liters | Standard Deviation 0.21678 |
Comparison: 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.p-value: 0.004395% CI: [0.0369, 0.1966]Least squares mean (SE)
Comparison: 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.p-value: 0.001995% CI: [0.0479, 0.2089]Least squares mean (SE)
Comparison: 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.p-value: 0.000495% CI: [0.0667, 0.2257]Least squares mean (SE)
Comparison: 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.p-value: <0.000195% CI: [0.0992, 0.2548]Least squares mean (SE)
Secondary
The Number of Subjects With Treatment-emergent Adverse Events
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | The Number of Subjects With Treatment-emergent Adverse Events | 15 participants |
| EP 101 12.5 mcg | The Number of Subjects With Treatment-emergent Adverse Events | 19 participants |
| EP-101 25 mcg | The Number of Subjects With Treatment-emergent Adverse Events | 18 participants |
| EP-101 50 mcg | The Number of Subjects With Treatment-emergent Adverse Events | 18 participants |
| EP-101 100 mcg | The Number of Subjects With Treatment-emergent Adverse Events | 17 participants |
Secondary
The Number of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | The Number of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation | 2 participants |
| EP 101 12.5 mcg | The Number of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation | 3 participants |
| EP-101 25 mcg | The Number of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation | 4 participants |
| EP-101 50 mcg | The Number of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation | 3 participants |
| EP-101 100 mcg | The Number of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation | 1 participants |
Secondary
The Number of Subjects With Treatment-emergent Serious Adverse Events
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | The Number of Subjects With Treatment-emergent Serious Adverse Events | 2 participants |
| EP 101 12.5 mcg | The Number of Subjects With Treatment-emergent Serious Adverse Events | 2 participants |
| EP-101 25 mcg | The Number of Subjects With Treatment-emergent Serious Adverse Events | 2 participants |
| EP-101 50 mcg | The Number of Subjects With Treatment-emergent Serious Adverse Events | 1 participants |
| EP-101 100 mcg | The Number of Subjects With Treatment-emergent Serious Adverse Events | 3 participants |
Secondary
The Peak FEV1 Change From Baseline
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
Population: The ITT population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | The Peak FEV1 Change From Baseline | 0.0931 liters | Standard Deviation 0.17808 |
| EP 101 12.5 mcg | The Peak FEV1 Change From Baseline | 0.2613 liters | Standard Deviation 0.18782 |
| EP-101 25 mcg | The Peak FEV1 Change From Baseline | 002960 liters | Standard Deviation 0.0026303 |
| EP-101 50 mcg | The Peak FEV1 Change From Baseline | 0.2552 liters | Standard Deviation 0.22395 |
| EP-101 100 mcg | The Peak FEV1 Change From Baseline | 0.3165 liters | Standard Deviation 0.21409 |
Secondary
The Percentage of Subjects With Treatment-emergent Adverse Events
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | The Percentage of Subjects With Treatment-emergent Adverse Events | 26.3 percentage of participants |
| EP 101 12.5 mcg | The Percentage of Subjects With Treatment-emergent Adverse Events | 34.5 percentage of participants |
| EP-101 25 mcg | The Percentage of Subjects With Treatment-emergent Adverse Events | 33.3 percentage of participants |
| EP-101 50 mcg | The Percentage of Subjects With Treatment-emergent Adverse Events | 31.6 percentage of participants |
| EP-101 100 mcg | The Percentage of Subjects With Treatment-emergent Adverse Events | 28.8 percentage of participants |
Secondary
The Percentage of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | The Percentage of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation | 3.5 percentage of participants |
| EP 101 12.5 mcg | The Percentage of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation | 5.5 percentage of participants |
| EP-101 25 mcg | The Percentage of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation | 7.4 percentage of participants |
| EP-101 50 mcg | The Percentage of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation | 5.3 percentage of participants |
| EP-101 100 mcg | The Percentage of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation | 1.7 percentage of participants |
Secondary
The Percentage of Subjects With Treatment-emergent Serious Adverse Events
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | The Percentage of Subjects With Treatment-emergent Serious Adverse Events | 3.5 percentage of participants |
| EP 101 12.5 mcg | The Percentage of Subjects With Treatment-emergent Serious Adverse Events | 3.6 percentage of participants |
| EP-101 25 mcg | The Percentage of Subjects With Treatment-emergent Serious Adverse Events | 3.7 percentage of participants |
| EP-101 50 mcg | The Percentage of Subjects With Treatment-emergent Serious Adverse Events | 1.8 percentage of participants |
| EP-101 100 mcg | The Percentage of Subjects With Treatment-emergent Serious Adverse Events | 5.1 percentage of participants |
Secondary
The Standardized Change From Baseline FEV1 AUC(0-12)
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
Time frame: Day 28
Population: The ITT population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | The Standardized Change From Baseline FEV1 AUC(0-12) | 0.0055 liters | Standard Deviation 0.15426 |
| EP 101 12.5 mcg | The Standardized Change From Baseline FEV1 AUC(0-12) | 0.1370 liters | Standard Deviation 0.17082 |
| EP-101 25 mcg | The Standardized Change From Baseline FEV1 AUC(0-12) | 0.1720 liters | Standard Deviation 0.2472 |
| EP-101 50 mcg | The Standardized Change From Baseline FEV1 AUC(0-12) | 0.1066 liters | Standard Deviation 0.20512 |
| EP-101 100 mcg | The Standardized Change From Baseline FEV1 AUC(0-12) | 0.1815 liters | Standard Deviation 0.18544 |
Secondary
The Standardized Change From Baseline FEV1 AUC(12-24)
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
Time frame: Day 28
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | The Standardized Change From Baseline FEV1 AUC(12-24) | -0.0725 liters | Standard Deviation 0.16509 |
| EP 101 12.5 mcg | The Standardized Change From Baseline FEV1 AUC(12-24) | 0.0578 liters | Standard Deviation 0.14054 |
| EP-101 25 mcg | The Standardized Change From Baseline FEV1 AUC(12-24) | 0.0563 liters | Standard Deviation 0.27985 |
| EP-101 50 mcg | The Standardized Change From Baseline FEV1 AUC(12-24) | 0.0692 liters | Standard Deviation 0.19252 |
| EP-101 100 mcg | The Standardized Change From Baseline FEV1 AUC(12-24) | 0.1284 liters | Standard Deviation 0.21688 |