Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
Primary objective: To investigate bronchodilator effect and safety of single doses of BI 1744 CL inhaled via Respimat inhaler, Secondary objective: to characterize pharmacokinetics of BI 1744 CL. Olodaterol dose 40 mcg was investigated only in the open-label extension part for additional PK assessments which are not defined as primary or secondary endpoints.
Interventions
DRUGsingle dose of 5 mcg
solution for inhalation
DRUGsingle dose of placebo
solution for inhalation
DRUGsingle dose of 40 mcg
solution for inhalation
DRUGsingle dose of 20 mcg
solution for inhalation
DRUGsingle dose of 2 mcg
solution for inhalation
DRUGsingle dose of 10 mcg
solution for inhalation
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of chronic obstructive pulmonary disease 2. Smoking history of more than 10-pack years
Exclusion criteria
1. History of asthma, allergic rhinitis, myocardial infarction or unstable of life-threatening cardiac arrhythmias 2. Marked baseline prolongation of QT/QTc interval
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Forced Expiratory Volume in One Second (FEV1) at 24 Hours After a Single-dose of Study Treatment | 24 hours post-dosing | Forced expiratory volume in one second (FEV1) at 24 hours after a single-dose of study treatment. Means are adjusted with test-day baseline, patient, treatment, and period as fixed effects. Test-day baseline value was defined as the value at 10 minutes before inhalation of study medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FEV1 AUC 0 - 12 Hours | -10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h and 12h post-dosing | The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 12 hours, using the trapezoidal rule divided by 12 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero. |
| FEV1 AUC 0 - 24 Hours | -10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 22h, 23h and 24h post-dosing | The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 24 hours, using the trapezoidal rule divided by 24 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero. |
| FEV1 AUC 12 - 24 Hours | 12h, 14h, 22h, 23h and 24h post-dosing | The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from 12 hours to 24 hours, using the trapezoidal rule divided by 12 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero. |
| Peak FEV1 From 0 to 3 Hours | 0 to 3 hours post-dosing | Peak FEV1 was defined as the maximum values of FEV1 from 0 to 3 hours. |
| Peak Forced Vital Capacity (FVC) From 0 to 3 Hours | 0 to 3 hours post-dosing | Peak FVC was defined as the maximum values of FVC from 0 to 3 hours. |
| FEV1 AUC 0 - 3 Hours | -10 minutes (min), 30min, 1 hour (h), 2h and 3h post-dosing | The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 3 hours, using the trapezoidal rule divided by 3 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero. |
| Time to Onset of Response | 0 to 3 hours post-dosing | Onset of the bronchodilator response after a single dose of study treatment was defined as the linear interpolation of the time of the first bronchodilator response and the time of the observation just prior to the first bronchodilator response (even if that is the baseline observation). If none of the FEV1 values in the first 3 hours after dosing exceeded 12% of the pre-dose value, then the onset was set to 3 hours plus 1 minute. |
| Number of Patients Requiring Rescue Medication on a Test-day | Visits 1,2,4,5,6 | Number of Patients Requiring Rescue Medication on a Test-day. Salbutamol inhalation aerosol MDI (Ventolin®, 100 μg/actuation) was provided for use as rescue medication. Administration of rescue medication can occur at any point during the pulmonary function testing as deemed necessary by the patient or the investigator. |
| Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG | 2 weeks | Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations). |
| Laboratory Testing: Average Change From Baseline of Potassium and Calcium | Baseline and Visit 6 | Laboratory testing: Average change from baseline of potassium and calcium measured on test-days |
| Time to Peak Bronchodilator Response | 0 to 3 hours post-dosing | A bronchodilator response was considered to have been achieved if an FEV1 measurement of at least 12% greater than the test-day baseline value was recorded at any time during the first 3 hours of observation after dosing. |
Countries
Netherlands
Participant flow
Recruitment details
A Pharmacokinetic sub-study to characterise the pharmacokinetics of 2 μg to 20 μg Olodaterol was planned in a subset of 18 patients. After preliminary evaluation of the data, an open-label extension was planned to investigate the safety, tolerability, and pharmacokinetics of single doses of 40 μg Olodaterol in the 18 patients of the PK sub-study.
Pre-assignment details
This was a randomised, Double-Blind, Placebo-Controlled, 5-Way crossover trial. Each treatment was only administered once in a single dose with a washout period of at least 14 days between treatments.
Participants by arm
| Arm | Count |
|---|---|
| Study Total Total number of patients treated in the study. This was a double-blind, 5-period crossover trial. Each of the 36 patients received placebo and 4 single doses of Olodaterol (Olo) (2 microgram (mcg), 5 mcg, 10 mcg, 20mcg) separated by a wash-out period of at least 14 days. | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (First Dose + Washout) | Adverse Event | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Period 3 (Third Dose + Washout) | Adverse Event | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Study Total |
|---|---|
| Age, Continuous | 65.0 years STANDARD_DEVIATION 9.8 |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 25 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 | 5 / 35 | 2 / 35 | 4 / 35 | 5 / 34 | 4 / 35 |
| serious Total, serious adverse events | 1 / 35 | 1 / 35 | 2 / 35 | 0 / 34 | 0 / 35 |
Outcome results
Primary
Forced Expiratory Volume in One Second (FEV1) at 24 Hours After a Single-dose of Study Treatment
Forced expiratory volume in one second (FEV1) at 24 hours after a single-dose of study treatment. Means are adjusted with test-day baseline, patient, treatment, and period as fixed effects. Test-day baseline value was defined as the value at 10 minutes before inhalation of study medication.
Time frame: 24 hours post-dosing
Population: Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data for FEV1 at 24 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Forced Expiratory Volume in One Second (FEV1) at 24 Hours After a Single-dose of Study Treatment | 0.916 L | Standard Error 0.014 |
| Olo 2 mcg | Forced Expiratory Volume in One Second (FEV1) at 24 Hours After a Single-dose of Study Treatment | 0.986 L | Standard Error 0.014 |
| Olo 5 mcg | Forced Expiratory Volume in One Second (FEV1) at 24 Hours After a Single-dose of Study Treatment | 1.015 L | Standard Error 0.014 |
| Olo 10 mcg | Forced Expiratory Volume in One Second (FEV1) at 24 Hours After a Single-dose of Study Treatment | 1.029 L | Standard Error 0.014 |
| Olo 20 mcg | Forced Expiratory Volume in One Second (FEV1) at 24 Hours After a Single-dose of Study Treatment | 1.035 L | Standard Error 0.014 |
p-value: 0.000595% CI: [0.031, 0.109]ANCOVA
p-value: <0.000195% CI: [0.06, 0.138]ANCOVA
p-value: <0.000195% CI: [0.074, 0.152]ANCOVA
p-value: <0.000195% CI: [0.08, 0.158]ANCOVA
Secondary
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).
Time frame: 2 weeks
Population: Safety set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG | Cardiac disorders | 0 percentage of participants |
| Placebo | Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG | Blood bilirubin increased | 0.0 percentage of participants |
| Olo 2 mcg | Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG | Cardiac disorders | 0 percentage of participants |
| Olo 2 mcg | Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG | Blood bilirubin increased | 0.0 percentage of participants |
| Olo 5 mcg | Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG | Cardiac disorders | 0 percentage of participants |
| Olo 5 mcg | Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG | Blood bilirubin increased | 0.0 percentage of participants |
| Olo 10 mcg | Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG | Blood bilirubin increased | 2.9 percentage of participants |
| Olo 10 mcg | Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG | Cardiac disorders | 0 percentage of participants |
| Olo 20 mcg | Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG | Cardiac disorders | 0 percentage of participants |
| Olo 20 mcg | Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG | Blood bilirubin increased | 0.0 percentage of participants |
Secondary
FEV1 AUC 0 - 12 Hours
The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 12 hours, using the trapezoidal rule divided by 12 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.
Time frame: -10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h and 12h post-dosing
Population: Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | FEV1 AUC 0 - 12 Hours | 0.954 L | Standard Error 0.012 |
| Olo 2 mcg | FEV1 AUC 0 - 12 Hours | 1.053 L | Standard Error 0.011 |
| Olo 5 mcg | FEV1 AUC 0 - 12 Hours | 1.093 L | Standard Error 0.011 |
| Olo 10 mcg | FEV1 AUC 0 - 12 Hours | 1.108 L | Standard Error 0.012 |
| Olo 20 mcg | FEV1 AUC 0 - 12 Hours | 1.138 L | Standard Error 0.011 |
p-value: <0.000195% CI: [0.068, 0.131]ANCOVA
p-value: <0.000195% CI: [0.107, 0.171]ANCOVA
p-value: <0.000195% CI: [0.122, 0.185]ANCOVA
p-value: <0.000195% CI: [0.152, 0.215]ANCOVA
Secondary
FEV1 AUC 0 - 24 Hours
The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 24 hours, using the trapezoidal rule divided by 24 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.
Time frame: -10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 22h, 23h and 24h post-dosing
Population: Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | FEV1 AUC 0 - 24 Hours | 0.923 L | Standard Error 0.011 |
| Olo 2 mcg | FEV1 AUC 0 - 24 Hours | 1.009 L | Standard Error 0.011 |
| Olo 5 mcg | FEV1 AUC 0 - 24 Hours | 1.040 L | Standard Error 0.011 |
| Olo 10 mcg | FEV1 AUC 0 - 24 Hours | 1.061 L | Standard Error 0.011 |
| Olo 20 mcg | FEV1 AUC 0 - 24 Hours | 1.085 L | Standard Error 0.011 |
p-value: <0.000195% CI: [0.056, 0.117]ANCOVA
p-value: <0.000195% CI: [0.087, 0.148]ANCOVA
p-value: <0.000195% CI: [0.107, 0.168]ANCOVA
p-value: <0.000195% CI: [0.132, 0.193]ANCOVA
Secondary
FEV1 AUC 0 - 3 Hours
The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 3 hours, using the trapezoidal rule divided by 3 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.
Time frame: -10 minutes (min), 30min, 1 hour (h), 2h and 3h post-dosing
Population: Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | FEV1 AUC 0 - 3 Hours | 0.997 L | Standard Error 0.011 |
| Olo 2 mcg | FEV1 AUC 0 - 3 Hours | 1.105 L | Standard Error 0.011 |
| Olo 5 mcg | FEV1 AUC 0 - 3 Hours | 1.152 L | Standard Error 0.011 |
| Olo 10 mcg | FEV1 AUC 0 - 3 Hours | 1.158 L | Standard Error 0.011 |
| Olo 20 mcg | FEV1 AUC 0 - 3 Hours | 1.189 L | Standard Error 0.011 |
p-value: <0.000195% CI: [0.077, 0.139]ANCOVA
p-value: <0.000195% CI: [0.124, 0.186]ANCOVA
p-value: <0.000195% CI: [0.13, 0.192]ANCOVA
p-value: <0.000195% CI: [0.161, 0.223]ANCOVA
Secondary
FEV1 AUC 12 - 24 Hours
The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from 12 hours to 24 hours, using the trapezoidal rule divided by 12 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.
Time frame: 12h, 14h, 22h, 23h and 24h post-dosing
Population: Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | FEV1 AUC 12 - 24 Hours | 0.891 L | Standard Error 0.012 |
| Olo 2 mcg | FEV1 AUC 12 - 24 Hours | 0.965 L | Standard Error 0.012 |
| Olo 5 mcg | FEV1 AUC 12 - 24 Hours | 0.987 L | Standard Error 0.012 |
| Olo 10 mcg | FEV1 AUC 12 - 24 Hours | 1.014 L | Standard Error 0.012 |
| Olo 20 mcg | FEV1 AUC 12 - 24 Hours | 1.032 L | Standard Error 0.012 |
p-value: <0.000195% CI: [0.041, 0.108]ANCOVA
p-value: <0.000195% CI: [0.062, 0.13]ANCOVA
p-value: <0.000195% CI: [0.089, 0.156]ANCOVA
p-value: <0.000195% CI: [0.107, 0.174]ANCOVA
Secondary
Laboratory Testing: Average Change From Baseline of Potassium and Calcium
Laboratory testing: Average change from baseline of potassium and calcium measured on test-days
Time frame: Baseline and Visit 6
Population: Safety set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | Laboratory Testing: Average Change From Baseline of Potassium and Calcium | Potassium (N=17, 18, 17, 17, 18) | 1.03 mmol/L |
| Placebo | Laboratory Testing: Average Change From Baseline of Potassium and Calcium | Calcium (N=18, 18, 17, 17, 18) | 1.02 mmol/L |
| Olo 2 mcg | Laboratory Testing: Average Change From Baseline of Potassium and Calcium | Potassium (N=17, 18, 17, 17, 18) | 1.01 mmol/L |
| Olo 2 mcg | Laboratory Testing: Average Change From Baseline of Potassium and Calcium | Calcium (N=18, 18, 17, 17, 18) | 1.00 mmol/L |
| Olo 5 mcg | Laboratory Testing: Average Change From Baseline of Potassium and Calcium | Potassium (N=17, 18, 17, 17, 18) | 0.99 mmol/L |
| Olo 5 mcg | Laboratory Testing: Average Change From Baseline of Potassium and Calcium | Calcium (N=18, 18, 17, 17, 18) | 1.00 mmol/L |
| Olo 10 mcg | Laboratory Testing: Average Change From Baseline of Potassium and Calcium | Calcium (N=18, 18, 17, 17, 18) | 1.01 mmol/L |
| Olo 10 mcg | Laboratory Testing: Average Change From Baseline of Potassium and Calcium | Potassium (N=17, 18, 17, 17, 18) | 0.98 mmol/L |
| Olo 20 mcg | Laboratory Testing: Average Change From Baseline of Potassium and Calcium | Potassium (N=17, 18, 17, 17, 18) | 0.97 mmol/L |
| Olo 20 mcg | Laboratory Testing: Average Change From Baseline of Potassium and Calcium | Calcium (N=18, 18, 17, 17, 18) | 1.01 mmol/L |
Secondary
Number of Patients Requiring Rescue Medication on a Test-day
Number of Patients Requiring Rescue Medication on a Test-day. Salbutamol inhalation aerosol MDI (Ventolin®, 100 μg/actuation) was provided for use as rescue medication. Administration of rescue medication can occur at any point during the pulmonary function testing as deemed necessary by the patient or the investigator.
Time frame: Visits 1,2,4,5,6
Population: Safety set which consisted of all randomised patients who had taken at least one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Patients Requiring Rescue Medication on a Test-day | 4 Number of Patients |
| Olo 2 mcg | Number of Patients Requiring Rescue Medication on a Test-day | 4 Number of Patients |
| Olo 5 mcg | Number of Patients Requiring Rescue Medication on a Test-day | 0 Number of Patients |
| Olo 10 mcg | Number of Patients Requiring Rescue Medication on a Test-day | 1 Number of Patients |
| Olo 20 mcg | Number of Patients Requiring Rescue Medication on a Test-day | 1 Number of Patients |
Secondary
Peak FEV1 From 0 to 3 Hours
Peak FEV1 was defined as the maximum values of FEV1 from 0 to 3 hours.
Time frame: 0 to 3 hours post-dosing
Population: Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Peak FEV1 From 0 to 3 Hours | 1.043 L | Standard Error 0.013 |
| Olo 2 mcg | Peak FEV1 From 0 to 3 Hours | 1.164 L | Standard Error 0.013 |
| Olo 5 mcg | Peak FEV1 From 0 to 3 Hours | 1.209 L | Standard Error 0.013 |
| Olo 10 mcg | Peak FEV1 From 0 to 3 Hours | 1.219 L | Standard Error 0.014 |
| Olo 20 mcg | Peak FEV1 From 0 to 3 Hours | 1.256 L | Standard Error 0.013 |
p-value: <0.000195% CI: [0.084, 0.158]ANCOVA
p-value: <0.000195% CI: [0.129, 0.203]ANCOVA
p-value: <0.000195% CI: [0.139, 0.214]ANCOVA
p-value: <0.000195% CI: [0.176, 0.25]ANCOVA
Secondary
Peak Forced Vital Capacity (FVC) From 0 to 3 Hours
Peak FVC was defined as the maximum values of FVC from 0 to 3 hours.
Time frame: 0 to 3 hours post-dosing
Population: Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Peak Forced Vital Capacity (FVC) From 0 to 3 Hours | 3.134 L | Standard Error 0.035 |
| Olo 2 mcg | Peak Forced Vital Capacity (FVC) From 0 to 3 Hours | 3.440 L | Standard Error 0.035 |
| Olo 5 mcg | Peak Forced Vital Capacity (FVC) From 0 to 3 Hours | 3.489 L | Standard Error 0.035 |
| Olo 10 mcg | Peak Forced Vital Capacity (FVC) From 0 to 3 Hours | 3.485 L | Standard Error 0.035 |
| Olo 20 mcg | Peak Forced Vital Capacity (FVC) From 0 to 3 Hours | 3.589 L | Standard Error 0.035 |
p-value: <0.000195% CI: [0.21, 0.402]ANCOVA
p-value: <0.000195% CI: [0.258, 0.452]ANCOVA
p-value: <0.000195% CI: [0.253, 0.447]ANCOVA
p-value: <0.000195% CI: [0.359, 0.551]ANCOVA
Secondary
Time to Onset of Response
Onset of the bronchodilator response after a single dose of study treatment was defined as the linear interpolation of the time of the first bronchodilator response and the time of the observation just prior to the first bronchodilator response (even if that is the baseline observation). If none of the FEV1 values in the first 3 hours after dosing exceeded 12% of the pre-dose value, then the onset was set to 3 hours plus 1 minute.
Time frame: 0 to 3 hours post-dosing
Population: Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Time to Onset of Response | 148.9 minutes | Standard Deviation 56.2 |
| Olo 2 mcg | Time to Onset of Response | 91.5 minutes | Standard Deviation 73.6 |
| Olo 5 mcg | Time to Onset of Response | 57.5 minutes | Standard Deviation 68.5 |
| Olo 10 mcg | Time to Onset of Response | 59.9 minutes | Standard Deviation 69.6 |
| Olo 20 mcg | Time to Onset of Response | 38.2 minutes | Standard Deviation 48.1 |
Secondary
Time to Peak Bronchodilator Response
A bronchodilator response was considered to have been achieved if an FEV1 measurement of at least 12% greater than the test-day baseline value was recorded at any time during the first 3 hours of observation after dosing.
Time frame: 0 to 3 hours post-dosing
Population: Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Time to Peak Bronchodilator Response | 102.0 minutes | Standard Deviation 57.4 |
| Olo 2 mcg | Time to Peak Bronchodilator Response | 92.6 minutes | Standard Deviation 55.1 |
| Olo 5 mcg | Time to Peak Bronchodilator Response | 98.6 minutes | Standard Deviation 53.8 |
| Olo 10 mcg | Time to Peak Bronchodilator Response | 83.8 minutes | Standard Deviation 46.6 |
| Olo 20 mcg | Time to Peak Bronchodilator Response | 96.9 minutes | Standard Deviation 39.9 |