Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Chronic Bronchitis, Anticholinergic, Emphysema, Long-acting muscarinic antagonist, COPD
Brief summary
The study will evaluate the efficacy, safety, and pharmacokinetics of GSK573719 compared with placebo in subjects with COPD
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate 3 doses of GSK573719 administered once-daily over 28 days in subjects with COPD.
Interventions
DRUGGSK573719 125mcg
125mcg once-daily
DRUGGSK573719 250mcg
250mcg once-daily
DRUGGSK573719 500mcg
500mcg once-daily
DRUGPlacebo
once-daily
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* A signed and dated written informed consent prior to study participation * Males or females of non-childbearing potential * 40 to 80 years of age * COPD diagnosis * 10 pack-years history or greater of cigarette smoking * Post-bronchodilator FEV1/FVC ratio of 0.70 or less * Post-bronchodilator FEV1 of 25 to 70% of predicted normal
Exclusion criteria
* Asthma * Other significant respiratory disorders besides COPD, including alpha-1 deficiency * Previous lung resection surgery * Chest X-ray or CP scan showing clinically significant abnormalities not due to COPD * Use of oral steroids or antibiotics for a COPD exacerbation within 6 weeks of screening * Hospitalization for COPD or pneumonia within 3 months of screening * Any significant disease that would put subject at risk through study participation * BMI greater than 35 * Pacemaker * Significantly abnormal ECG or clinical lab finding (including Hepatitis B or C) * Cancer * Allergy or hypersensitivity to anticholinergics or inhaler excipients * Diseases that would contraindicate the use of anticholinergics * Use of oral corticosteroids within 6 weeks of screening * Use of long-acting beta-agonists within 48 hours of screening * Use of tiotropium within 14 days of screening * Use of theophyllines or anti-leukotrienes within 48 hours of screening * Use of short-acting bronchodilators within 4 to 6 hours of screening * Use of investigational medicines within 30 days of screening * Use of high dose inhaled corticosteroids * Use of long-term oxygen therapy, CPAP or NIPPV * Participation in acute phase of pulmonary rehabilitation program * History of alcohol or drug abuse within 2 years prior to screening * History of psychiatric disease limiting validity of consent * Affiliation with the investigative site * Previous use of GSK573719
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 29 | Baseline and Day 29 | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 29 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 28. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between trough on Day 29 and Baseline. Analysis was performed using a repeated measures model with covariates of Baseline (BL), country, sex, age, treatment, smoking status, day, day by Baseline interaction, and day by treatment interaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 1 and Day 28 | Baseline, Day 1, and Day 28 | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the FEV1/time curve (AUC), and then dividing the value by the time interval over which the AUC was calculated. The weighted mean was calculated using the 0-6 hour post-dose measurements at Days 1 and 28, which included pre-dose (30 minutes prior to dosing on Day 1, or 24 hours after the previous day's dose on Day 28), and post-dose at 15 minutes, 30 minutes, 1 hour, 3 hours, and 6 hours. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between weighted mean at Days 1 and 28 and Baseline. Analysis was performed using a repeated measures model with covariates of Baseline, country, sex, age, treatment, smoking status, day, day by Baseline interaction, and day by treatment interaction. |
| Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Baseline, Day 1, and Day 28 | Serial spirometry assessments were conducted on Day 1 and Day 28 over the course of 24 hours and were obtained 0 (Day 28 only), 1, 3, 6, 23, and 24 hours after dosing. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between FEV1 on Days 1 and 28 and Baseline. |
Countries
Estonia, Germany, Poland, United States
Participant flow
Pre-assignment details
The study consisted of a Run-in Period of 5 to 8 days, followed by a 28-day Treatment Period. A total of 421 participants were screened; of these, 125 were screen failures, 10 were Run-in failures, 288 were randomized, and 285 received at least one dose of study drug (three participants were randomized but did not receive study drug).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days. | 71 |
| UMEC 125 µg Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days. | 71 |
| UMEC 250 µg Participants received UMEC 250 µg QD in the morning via a DPI for 28 days. | 72 |
| UMEC 500 µg Participants received UMEC 500 µg QD in the morning via a DPI for 28 days. | 71 |
| Total | 285 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 2 | 1 |
| Overall Study | Lack of Efficacy | 3 | 2 | 0 | 3 |
| Overall Study | Protocol-defined Stopping Criteria | 0 | 1 | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 1 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 2 |
Baseline characteristics
| Characteristic | Placebo | UMEC 125 µg | UMEC 250 µg | UMEC 500 µg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 62.3 Years STANDARD_DEVIATION 6.8 | 60.1 Years STANDARD_DEVIATION 8.75 | 60.3 Years STANDARD_DEVIATION 8.45 | 62.6 Years STANDARD_DEVIATION 9.3 | 61.4 Years STANDARD_DEVIATION 8.41 |
| Race/Ethnicity, Customized African American/African Heritage | 1 Participants | 4 Participants | 3 Participants | 1 Participants | 9 Participants |
| Race/Ethnicity, Customized African American/African Heritage & White | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 70 Participants | 67 Participants | 69 Participants | 69 Participants | 275 Participants |
| Sex: Female, Male Female | 24 Participants | 35 Participants | 30 Participants | 34 Participants | 123 Participants |
| Sex: Female, Male Male | 47 Participants | 36 Participants | 42 Participants | 37 Participants | 162 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 71 | 5 / 71 | 9 / 72 | 13 / 71 |
| serious Total, serious adverse events | 0 / 71 | 1 / 71 | 1 / 72 | 1 / 71 |
Outcome results
Primary
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 29
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 29 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 28. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between trough on Day 29 and Baseline. Analysis was performed using a repeated measures model with covariates of Baseline (BL), country, sex, age, treatment, smoking status, day, day by Baseline interaction, and day by treatment interaction.
Time frame: Baseline and Day 29
Population: Intent-to-Treat (ITT) Population: all participants randomized to treatment who received \>=1 dose of randomized study medication in the treatment period. All participants with \>=1 post-BL assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 29.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 29 | 0.013 Liters | Standard Error 0.025 |
| UMEC 125 µg | Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 29 | 0.171 Liters | Standard Error 0.025 |
| UMEC 250 µg | Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 29 | 0.181 Liters | Standard Error 0.025 |
| UMEC 500 µg | Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 29 | 0.163 Liters | Standard Error 0.025 |
p-value: <0.00195% CI: [0.088, 0.229]Repeated Measures Analysis of Covariance
p-value: <0.00195% CI: [0.099, 0.238]Repeated Measures Analysis of Covariance
p-value: <0.00195% CI: [0.08, 0.22]Repeated Measures Analysis of Covariance
Secondary
Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28
Serial spirometry assessments were conducted on Day 1 and Day 28 over the course of 24 hours and were obtained 0 (Day 28 only), 1, 3, 6, 23, and 24 hours after dosing. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between FEV1 on Days 1 and 28 and Baseline.
Time frame: Baseline, Day 1, and Day 28
Population: ITT Population. All participants with \>=1 post-BL assessment and non-missing covariate data are included in the analysis. Different participants may have been analyzed at different time points (represented by n=X, X, X, X in the category titles), so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 28, 24 hours, n=67, 64, 68, 64 | 0.024 Liters | Standard Error 0.025 |
| Placebo | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 28, 3 hours, n=67, 65, 67, 64 | 0.008 Liters | Standard Error 0.026 |
| Placebo | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 1, 3 hours, n=70, 71, 72, 71 | 0.008 Liters | Standard Error 0.018 |
| Placebo | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 28, 23 hours, n=67, 64, 68, 64 | -0.013 Liters | Standard Error 0.026 |
| Placebo | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 28, 6 hours, n=65, 65, 68, 64 | -0.005 Liters | Standard Error 0.028 |
| Placebo | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 28, 0 hours, n=67, 64, 69, 65 | -0.017 Liters | Standard Error 0.024 |
| Placebo | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 1, 24 hours, n=69, 71, 72, 70 | -0.002 Liters | Standard Error 0.019 |
| Placebo | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 1, 23 hours, n=70, 70, 72, 70 | -0.036 Liters | Standard Error 0.019 |
| Placebo | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 1, 6 hours, n=70, 71, 72, 70 | -0.004 Liters | Standard Error 0.019 |
| Placebo | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 28, 1 hour, n=67, 64, 68, 65 | -0.008 Liters | Standard Error 0.025 |
| Placebo | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 1, 1 hour, n=70, 71, 72, 71 | 0.013 Liters | Standard Error 0.015 |
| UMEC 125 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 28, 1 hour, n=67, 64, 68, 65 | 0.207 Liters | Standard Error 0.026 |
| UMEC 125 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 1, 3 hours, n=70, 71, 72, 71 | 0.255 Liters | Standard Error 0.018 |
| UMEC 125 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 1, 24 hours, n=69, 71, 72, 70 | 0.211 Liters | Standard Error 0.018 |
| UMEC 125 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 28, 3 hours, n=67, 65, 67, 64 | 0.267 Liters | Standard Error 0.026 |
| UMEC 125 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 28, 23 hours, n=67, 64, 68, 64 | 0.144 Liters | Standard Error 0.027 |
| UMEC 125 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 28, 24 hours, n=67, 64, 68, 64 | 0.204 Liters | Standard Error 0.026 |
| UMEC 125 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 1, 1 hour, n=70, 71, 72, 71 | 0.196 Liters | Standard Error 0.015 |
| UMEC 125 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 1, 6 hours, n=70, 71, 72, 70 | 0.232 Liters | Standard Error 0.019 |
| UMEC 125 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 1, 23 hours, n=70, 70, 72, 70 | 0.171 Liters | Standard Error 0.019 |
| UMEC 125 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 28, 0 hours, n=67, 64, 69, 65 | 0.165 Liters | Standard Error 0.024 |
| UMEC 125 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 28, 6 hours, n=65, 65, 68, 64 | 0.206 Liters | Standard Error 0.028 |
| UMEC 250 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 1, 23 hours, n=70, 70, 72, 70 | 0.186 Liters | Standard Error 0.019 |
| UMEC 250 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 28, 1 hour, n=67, 64, 68, 65 | 0.182 Liters | Standard Error 0.025 |
| UMEC 250 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 1, 24 hours, n=69, 71, 72, 70 | 0.216 Liters | Standard Error 0.018 |
| UMEC 250 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 1, 3 hours, n=70, 71, 72, 71 | 0.274 Liters | Standard Error 0.018 |
| UMEC 250 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 28, 6 hours, n=65, 65, 68, 64 | 0.181 Liters | Standard Error 0.027 |
| UMEC 250 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 1, 6 hours, n=70, 71, 72, 70 | 0.221 Liters | Standard Error 0.019 |
| UMEC 250 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 28, 3 hours, n=67, 65, 67, 64 | 0.204 Liters | Standard Error 0.026 |
| UMEC 250 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 28, 24 hours, n=67, 64, 68, 64 | 0.192 Liters | Standard Error 0.025 |
| UMEC 250 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 28, 23 hours, n=67, 64, 68, 64 | 0.161 Liters | Standard Error 0.026 |
| UMEC 250 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 28, 0 hours, n=67, 64, 69, 65 | 0.203 Liters | Standard Error 0.024 |
| UMEC 250 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 1, 1 hour, n=70, 71, 72, 71 | 0.212 Liters | Standard Error 0.015 |
| UMEC 500 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 28, 1 hour, n=67, 64, 68, 65 | 0.067 Liters | Standard Error 0.026 |
| UMEC 500 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 1, 3 hours, n=70, 71, 72, 71 | 0.227 Liters | Standard Error 0.018 |
| UMEC 500 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 28, 0 hours, n=67, 64, 69, 65 | 0.140 Liters | Standard Error 0.024 |
| UMEC 500 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 28, 3 hours, n=67, 65, 67, 64 | 0.168 Liters | Standard Error 0.026 |
| UMEC 500 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 1, 6 hours, n=70, 71, 72, 70 | 0.186 Liters | Standard Error 0.019 |
| UMEC 500 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 1, 23 hours, n=70, 70, 72, 70 | 0.107 Liters | Standard Error 0.019 |
| UMEC 500 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 1, 24 hours, n=69, 71, 72, 70 | 0.153 Liters | Standard Error 0.018 |
| UMEC 500 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 28, 6 hours, n=65, 65, 68, 64 | 0.141 Liters | Standard Error 0.028 |
| UMEC 500 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 1, 1 hour, n=70, 71, 72, 71 | 0.145 Liters | Standard Error 0.015 |
| UMEC 500 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 28, 23 hours, n=67, 64, 68, 64 | 0.157 Liters | Standard Error 0.027 |
| UMEC 500 µg | Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 | Day 28, 24 hours, n=67, 64, 68, 64 | 0.170 Liters | Standard Error 0.026 |
Secondary
Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 1 and Day 28
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the FEV1/time curve (AUC), and then dividing the value by the time interval over which the AUC was calculated. The weighted mean was calculated using the 0-6 hour post-dose measurements at Days 1 and 28, which included pre-dose (30 minutes prior to dosing on Day 1, or 24 hours after the previous day's dose on Day 28), and post-dose at 15 minutes, 30 minutes, 1 hour, 3 hours, and 6 hours. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between weighted mean at Days 1 and 28 and Baseline. Analysis was performed using a repeated measures model with covariates of Baseline, country, sex, age, treatment, smoking status, day, day by Baseline interaction, and day by treatment interaction.
Time frame: Baseline, Day 1, and Day 28
Population: ITT Population. Participants (par.) with \>=1 post-BL assessment and non-missing covariate data are included in the analysis. Different par. may have been analyzed at different time points (n=X, X, X, X in the category titles), so the overall number of par. analyzed reflects everyone in the ITT Population with data avaialable at \>=1 time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 1 and Day 28 | Day 1, n=70, 70, 71, 70 | 0.005 Liters | Standard Error 0.015 |
| Placebo | Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 1 and Day 28 | Day 28, n=65, 64, 68, 64 | 0.009 Liters | Standard Error 0.024 |
| UMEC 125 µg | Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 1 and Day 28 | Day 1, n=70, 70, 71, 70 | 0.211 Liters | Standard Error 0.015 |
| UMEC 125 µg | Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 1 and Day 28 | Day 28, n=65, 64, 68, 64 | 0.220 Liters | Standard Error 0.024 |
| UMEC 250 µg | Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 1 and Day 28 | Day 28, n=65, 64, 68, 64 | 0.204 Liters | Standard Error 0.023 |
| UMEC 250 µg | Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 1 and Day 28 | Day 1, n=70, 70, 71, 70 | 0.224 Liters | Standard Error 0.014 |
| UMEC 500 µg | Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 1 and Day 28 | Day 28, n=65, 64, 68, 64 | 0.122 Liters | Standard Error 0.024 |
| UMEC 500 µg | Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 1 and Day 28 | Day 1, n=70, 70, 71, 70 | 0.173 Liters | Standard Error 0.015 |