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| ID | Type | Description | Link |
|---|---|---|---|
| EudtaCT No: 2008-006334-10 |
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The primary objective of the trial is to determine the effect of BI 17444Cl on the lung function over a 24-hour period, when it is inhaled using the Respimat inhaler in patients with chronic obstructive pulmonary disease. In the trial four treatments of each 3 weeks of duration are included: 2 dosages in a once daily administration and 2 dosages for administration twice daily.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1744 CL | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After 3 Weeks of Treatment | Response was defined as change from baseline. Baseline FEV1 AUC (0-12) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres. | Day 0: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to planned morning dose on day 1; Day 21: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to morning dose |
| FEV1 Area Under Curve 12-24 h (AUC 12-24h) Response After 3 Weeks of Treatment | Response was defined as change from baseline. Baseline FEV1 AUC (12-24) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres. | Day 0: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to planned evening dose on day 1; Day 21: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to evening dose |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 Area Under Curve 0-24 h (AUC 0-24h) Response After 3 Weeks of Treatment | Response was defined as change from baseline. Baseline FEV1 AUC (0-24) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres. | Day0:-0:10,0:30,1,2,3,4,6,8,10,11:50h relative to planned morning dose on day1,0:30,1,2,10,11,11:50h relative to planned evening dose on day1; Day21:-0:10,0:30,1,2,3,4,6,8,10,11:50h relative to morning dose,0:30,1,2,10,11,11:50h relative to evening dose |
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Inclusion Criteria:
All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions
All patients must have a diagnosis of COPD and must meet the following spirometric criteria:
Patients must have relatively stable airway obstruction with a post-bronchodilator FEV1 < 80% of predicted normal and a post-bronchodilator FEV1 / FVC < 70% at Visit 1
Male or female patients, 40 years of age or older
Patients must be current or ex-smokers with a smoking history of more than 10 pack years
Patients must be able to perform technically acceptable pulmonary function tests
Patients must be able to inhale medication in a competent manner from the Respimat inhaler and from a metered dose inhaler (MDI).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1222.26.32008 Boehringer Ingelheim Investigational Site | Genk | Belgium | ||||
| 1222.26.32006 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25776199 | Derived | Joos GF, Aumann JL, Coeck C, Korducki L, Hamilton AL, Kunz C, Aalbers R. A randomised, double-blind, four-way, crossover trial comparing the 24-h FEV1 profile for once-daily versus twice-daily treatment with olodaterol, a novel long-acting beta2-agonist, in patients with chronic obstructive pulmonary disease. Respir Med. 2015 May;109(5):606-15. doi: 10.1016/j.rmed.2015.02.005. Epub 2015 Feb 14. |
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This was a multi-centre, randomised, double-blind, 4-way crossover trial. The duration of each treatment period was 3 weeks with no washout period between treatments.
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| ID | Title | Description |
|---|---|---|
| FG000 | Olo 2mcg Bid / Olo 10mcg qd / Olo 5mcg qd / Olo 5mcg Bid | Patients were administered Olodaterol 2 mcg bid in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 5 mcg qd in the third period and Olodaterol 5 mcg bid in the fourth period. Olodaterol was administered via the Respimat inhaler. |
| FG001 | Olo 5mcg qd / Olo 2mcg Bid / Olo 5mcg Bid / Olo 10mcg qd | Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 2 mcg bid in the second period, Olodaterol 5 mcg bid in the third period and Olodaterol 10 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler. |
| FG002 | Olo 5mcg Bid / Olo 5mcg qd / Olo 10mcg qd / Olo 2mcg Bid | Patients were administered Olodaterol 5 mcg bid in the first period, Olodaterol 5 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Olodaterol 2 mcg bid in the fourth period. Olodaterol was administered via the Respimat inhaler. |
| FG003 | Olo 10mcg qd / Olo 5mcg Bid / Olo 2mcg Bid / Olo 5mcg qd | Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 5 mcg bid in the second period, Olodaterol 2 mcg bid in the third period and Olodaterol 5 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated set, includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Total | Total number of patients treated in the study. This was a randomised, double-blind, active-controlled, 4 way crossover trial. 47 patients were assigned randomly to one of 4 treatment sequences in which they received each of the 4 treatments. The duration of each treatment period was 3 weeks with no washout period between treatments. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After 3 Weeks of Treatment | Response was defined as change from baseline. Baseline FEV1 AUC (0-12) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres. | Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period. | Posted | Least Squares Mean | Standard Error | Liter | Day 0: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to planned morning dose on day 1; Day 21: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to morning dose |
|
3 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Olo 2 mcg Bid | Olodaterol 2 mcg bid delivered by the Respimat Inhaler. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C549647 | olodaterol |
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| Peak FEV1 (0-3h) Response After 3 Weeks | Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after the last dose after three weeks of treatment. | Baseline, 3 weeks |
| Trough FEV1 Response | Response was defined as change from baseline. Study baseline trough FEV1 was defined as the mean of the available pre-dose trough FEV1 values prior to first dose of treatment. Trough values were the mean of values obtained 23h and 23 h 50 min after the last dose of study drug after three weeks of treatment . | Baseline, 3 weeks |
| FVC Area Under Curve 0-12 h (AUC 0-12h) Response After 3 Weeks of Treatment | Response was defined as change from baseline. Baseline FVC AUC (0-12) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FVC AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres. | Day 0: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to planned morning dose on day 1; Day 21: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to morning dose |
| FVC Area Under Curve 12-24 h (AUC 12-24h) Response After 3 Weeks of Treatment | Response was defined as change from baseline. Baseline FVC AUC (12-24) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FVC AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres. | Day 0: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to planned evening dose on day 1; Day 21: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to evening dose |
| FVC Area Under Curve 0-24 h (AUC 0-24h) Response After 3 Weeks of Treatment | Response was defined as change from baseline. Baseline FVC AUC (0-24) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FVC AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres. | Day0:-0:10,0:30,1,2,3,4,6,8,10,11:50h relative to planned morning dose on day1, 0:30,1,2,10,11,11:50h relative to planned evening dose on day1; Day21:-0:10,0:30,1,2,3,4,6,8,10,11:50h relative to morning dose,0:30,1,2,10,11,11:50h relative to evening dose |
| Peak FVC (0-3h) Response After 3 Weeks | Response was defined as change from baseline. Study baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after the last dose after three weeks of treatment. | Baseline, 3 weeks |
| Trough FVC Response | Response was defined as change from baseline. Study baseline trough FVC was defined as the mean of the available pre-dose trough FVC values prior to first dose of treatment. Trough values were the mean of values obtained 23h and 23 h 50 min after the last dose of study drug after three weeks of treatment . | Baseline, 3 weeks |
| Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis, ECG and Physical Examination | 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 related to treatment (cardiac disorders and investigations). | 3 weeks |
| Pharmacokinetics (PK): Concentration of the Analyte in Plasma Measured at 0.167 Hours Post Dosing at Steady State | Steady state concentration of the analyte in plasma measured at 0.167 hours post dosing in week 3. The start of inhalation was used as time point 0 for calculation of pharmacokinetic parameters. Descriptive statistics were calculated only if N>=16 had concentrations within the validated concentration range. | 3 weeks |
| Pharmacokinetics (PK): Amount of Analyte That is Eliminated in Urine at Steady State From the Time Point 0 Hours to Time Point 12 Hours | Amount of analyte that is eliminated in urine at steady state from the time point 0 hours to time point 12 hours after dosing in week 3 (after the morning dose for the bid dose regimens). The start of inhalation was used as time point 0 for calculation of pharmacokinetic parameters. Descriptive statistics were calculated only if N>=16 had concentrations within the validated concentration range. | 3 weeks |
| Pharmacokinetics (PK): Amount of Analyte That is Eliminated in Urine at Steady State From the Time Point 0 Hours to Time Point 24 Hours | Amount of analyte that is eliminated in urine at steady state from the time point 0 hours to time point 24 hours after dosing in week 3. The start of inhalation was used as time point 0 for calculation of pharmacokinetic parameters. Descriptive statistics were calculated only if N>=16 had concentrations within the validated concentration range. | 3 weeks |
| Pharmacokinetics (PK): Fraction of Analyte Eliminated in Urine at Steady State From Time Point 0 Hours to Time Point 12 Hours | Fraction of analyte eliminated in urine at steady state from time point 0 hours to time point 12 hours after dosing in week 3 (after the morning dose for the bid dose regimens). The start of inhalation was used as time point 0 for calculation of pharmacokinetic parameters. Descriptive statistics were calculated only if N>=16 had concentrations within the validated concentration range. | 3 weeks |
| Pharmacokinetics (PK): Fraction of Analyte Eliminated in Urine at Steady State From Time Point 0 Hours to Time Point 24 Hours | Fraction of analyte eliminated in urine at steady state from time point 0 hours to time point 24 hours after dosing in week 3. The start of inhalation was used as time point 0 for calculation of pharmacokinetic parameters. Descriptive statistics were calculated only if N>=16 had concentrations within the validated concentration range. | 3 weeks |
| Ghent |
| Belgium |
| 1222.26.32007 Boehringer Ingelheim Investigational Site | Hasselt | Belgium |
| 1222.26.31002 Boehringer Ingelheim Investigational Site | Eindhoven | Netherlands |
| 1222.26.31001 Boehringer Ingelheim Investigational Site | Heerlen | Netherlands |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd delivered by the Respimat Inhaler. |
| OG002 | Olo 5 mcg Bid | Olodaterol 5 mcg bid delivered by the Respimat Inhaler. |
| OG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd delivered by the Respimat Inhaler. |
|
|
|
| Primary | FEV1 Area Under Curve 12-24 h (AUC 12-24h) Response After 3 Weeks of Treatment | Response was defined as change from baseline. Baseline FEV1 AUC (12-24) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres. | Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period. | Posted | Least Squares Mean | Standard Error | Liter | Day 0: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to planned evening dose on day 1; Day 21: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to evening dose |
|
|
|
|
| Secondary | FEV1 Area Under Curve 0-24 h (AUC 0-24h) Response After 3 Weeks of Treatment | Response was defined as change from baseline. Baseline FEV1 AUC (0-24) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres. | Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period. | Posted | Least Squares Mean | Standard Error | Liter | Day0:-0:10,0:30,1,2,3,4,6,8,10,11:50h relative to planned morning dose on day1,0:30,1,2,10,11,11:50h relative to planned evening dose on day1; Day21:-0:10,0:30,1,2,3,4,6,8,10,11:50h relative to morning dose,0:30,1,2,10,11,11:50h relative to evening dose |
|
|
|
|
| Secondary | Peak FEV1 (0-3h) Response After 3 Weeks | Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after the last dose after three weeks of treatment. | Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period. | Posted | Least Squares Mean | Standard Error | Liter | Baseline, 3 weeks |
|
|
|
|
| Secondary | Trough FEV1 Response | Response was defined as change from baseline. Study baseline trough FEV1 was defined as the mean of the available pre-dose trough FEV1 values prior to first dose of treatment. Trough values were the mean of values obtained 23h and 23 h 50 min after the last dose of study drug after three weeks of treatment . | Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period. | Posted | Least Squares Mean | Standard Error | Liter | Baseline, 3 weeks |
|
|
|
|
| Secondary | FVC Area Under Curve 0-12 h (AUC 0-12h) Response After 3 Weeks of Treatment | Response was defined as change from baseline. Baseline FVC AUC (0-12) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FVC AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres. | Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period. | Posted | Least Squares Mean | Standard Error | Liter | Day 0: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to planned morning dose on day 1; Day 21: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to morning dose |
|
|
|
|
| Secondary | FVC Area Under Curve 12-24 h (AUC 12-24h) Response After 3 Weeks of Treatment | Response was defined as change from baseline. Baseline FVC AUC (12-24) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FVC AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres. | Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period. | Posted | Least Squares Mean | Standard Error | Liter | Day 0: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to planned evening dose on day 1; Day 21: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to evening dose |
|
|
|
|
| Secondary | FVC Area Under Curve 0-24 h (AUC 0-24h) Response After 3 Weeks of Treatment | Response was defined as change from baseline. Baseline FVC AUC (0-24) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FVC AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres. | Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period. | Posted | Least Squares Mean | Standard Error | Liter | Day0:-0:10,0:30,1,2,3,4,6,8,10,11:50h relative to planned morning dose on day1, 0:30,1,2,10,11,11:50h relative to planned evening dose on day1; Day21:-0:10,0:30,1,2,3,4,6,8,10,11:50h relative to morning dose,0:30,1,2,10,11,11:50h relative to evening dose |
|
|
|
|
| Secondary | Peak FVC (0-3h) Response After 3 Weeks | Response was defined as change from baseline. Study baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after the last dose after three weeks of treatment. | Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period. | Posted | Least Squares Mean | Standard Error | Liter | Baseline, 3 weeks |
|
|
|
|
| Secondary | Trough FVC Response | Response was defined as change from baseline. Study baseline trough FVC was defined as the mean of the available pre-dose trough FVC values prior to first dose of treatment. Trough values were the mean of values obtained 23h and 23 h 50 min after the last dose of study drug after three weeks of treatment . | Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period. | Posted | Least Squares Mean | Standard Error | Liter | Baseline, 3 weeks |
|
|
|
|
| Secondary | Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis, ECG and Physical Examination | 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 related to treatment (cardiac disorders and investigations). | Treated set. | Posted | Number | percentage of participants | 3 weeks |
|
|
|
| Secondary | Pharmacokinetics (PK): Concentration of the Analyte in Plasma Measured at 0.167 Hours Post Dosing at Steady State | Steady state concentration of the analyte in plasma measured at 0.167 hours post dosing in week 3. The start of inhalation was used as time point 0 for calculation of pharmacokinetic parameters. Descriptive statistics were calculated only if N>=16 had concentrations within the validated concentration range. | All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of PK parameters or had insufficient data. In the "Olo 2 mcg Bid" Arm, there were only 14 patients with values within the validated concentration range. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | 3 weeks |
|
|
|
| Secondary | Pharmacokinetics (PK): Amount of Analyte That is Eliminated in Urine at Steady State From the Time Point 0 Hours to Time Point 12 Hours | Amount of analyte that is eliminated in urine at steady state from the time point 0 hours to time point 12 hours after dosing in week 3 (after the morning dose for the bid dose regimens). The start of inhalation was used as time point 0 for calculation of pharmacokinetic parameters. Descriptive statistics were calculated only if N>=16 had concentrations within the validated concentration range. | All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of PK parameters or had insufficient data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng | 3 weeks |
|
|
|
| Secondary | Pharmacokinetics (PK): Amount of Analyte That is Eliminated in Urine at Steady State From the Time Point 0 Hours to Time Point 24 Hours | Amount of analyte that is eliminated in urine at steady state from the time point 0 hours to time point 24 hours after dosing in week 3. The start of inhalation was used as time point 0 for calculation of pharmacokinetic parameters. Descriptive statistics were calculated only if N>=16 had concentrations within the validated concentration range. | All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of PK parameters or had insufficient data. This endpoint was only calculated for the two qd dose regimens, therefore the number of patients in the Olo 2 Mcg Bid Arm and the Olo 5 Mcg Bid Arm is 0. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng | 3 weeks |
|
|
|
| Secondary | Pharmacokinetics (PK): Fraction of Analyte Eliminated in Urine at Steady State From Time Point 0 Hours to Time Point 12 Hours | Fraction of analyte eliminated in urine at steady state from time point 0 hours to time point 12 hours after dosing in week 3 (after the morning dose for the bid dose regimens). The start of inhalation was used as time point 0 for calculation of pharmacokinetic parameters. Descriptive statistics were calculated only if N>=16 had concentrations within the validated concentration range. | All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of PK parameters or had insufficient data. | Posted | Geometric Mean | Geometric Coefficient of Variation | percent | 3 weeks |
|
|
|
| Secondary | Pharmacokinetics (PK): Fraction of Analyte Eliminated in Urine at Steady State From Time Point 0 Hours to Time Point 24 Hours | Fraction of analyte eliminated in urine at steady state from time point 0 hours to time point 24 hours after dosing in week 3. The start of inhalation was used as time point 0 for calculation of pharmacokinetic parameters. Descriptive statistics were calculated only if N>=16 had concentrations within the validated concentration range. | All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of PK parameters or had insufficient data. This endpoint was only calculated for the two qd dose regimens, therefore the number of patients in the Olo 2 Mcg Bid Arm and the Olo 5 Mcg Bid Arm is 0. | Posted | Geometric Mean | Geometric Coefficient of Variation | percent | 3 weeks |
|
|
|
| 1 |
| 47 |
| 1 |
| 47 |
| EG001 | Olo 5 mcg qd | Olodaterol 5 mcg qd delivered by the Respimat Inhaler. | 0 | 47 | 4 | 47 |
| EG002 | Olo 5 mcg Bid | Olodaterol 5 mcg bid delivered by the Respimat Inhaler. | 0 | 46 | 4 | 46 |
| EG003 | Olo 10 mcg qd | Olodaterol 10 mcg qd delivered by the Respimat Inhaler. | 0 | 46 | 3 | 46 |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Mixed Models Analysis |
Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. |
| 0.0019 |
| Mean Difference (Final Values) |
| -0.047 |
| Standard Error of the Mean |
| 0.015 |
| 95 |
| -0.076 |
| -0.017 |
Olo 5 mcg qd minus Olo 5 mcg bid |
| No |
| Superiority or Other |
| Mixed Models Analysis | Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. | 0.4111 | Mean Difference (Final Values) | -0.012 | Standard Error of the Mean | 0.015 | 95 | -0.041 | 0.017 | Olo 5 mcg qd minus Olo 2 mcg bid | No | Superiority or Other |
| Mixed Models Analysis | Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. | 0.7090 | Mean Difference (Final Values) | -0.006 | Standard Error of the Mean | 0.015 | 95 | -0.035 | 0.024 | Olo 10 mcg qd minus Olo 5 mcg qd | No | Superiority or Other |
| Mixed Models Analysis | Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. | 0.0211 | Mean Difference (Final Values) | 0.035 | Standard Error of the Mean | 0.015 | 95 | 0.005 | 0.064 | Olo 5 mcg bid minus Olo 2 mcg bid | No | Superiority or Other |
| Mixed Models Analysis |
Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. |
| 0.3444 |
| Mean Difference (Final Values) |
| -0.013 |
| Standard Error of the Mean |
| 0.014 |
| 95 |
| -0.040 |
| 0.014 |
Olo 5 mcg qd minus Olo 5 mcg bid |
| No |
| Superiority or Other |
| Mixed Models Analysis | Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. | 0.1161 | Mean Difference (Final Values) | 0.022 | Standard Error of the Mean | 0.014 | 95 | -0.005 | 0.049 | Olo 5 mcg qd minus Olo 2 mcg bid | No | Superiority or Other |
| Mixed Models Analysis | Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. | 0.6789 | Mean Difference (Final Values) | -0.006 | Standard Error of the Mean | 0.014 | 95 | -0.033 | 0.021 | Olo 10 mcg qd minus Olo 5 mcg qd | No | Superiority or Other |
| Mixed Models Analysis | Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. | 0.0129 | Mean Difference (Final Values) | 0.035 | Standard Error of the Mean | 0.014 | 95 | 0.007 | 0.062 | Olo 5 mcg bid minus Olo 2 mcg bid | No | Superiority or Other |
| Mixed Models Analysis |
Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. |
| 0.2597 |
| Mean Difference (Final Values) |
| 0.020 |
| Standard Error of the Mean |
| 0.017 |
| 95 |
| -0.015 |
| 0.054 |
Olo 5 mcg qd minus Olo 5 mcg bid |
| No |
| Superiority or Other |
| Mixed Models Analysis | Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. | 0.0006 | Mean Difference (Final Values) | 0.062 | Standard Error of the Mean | 0.018 | 95 | 0.027 | 0.097 | Olo 5 mcg qd minus Olo 2 mcg bid | No | Superiority or Other |
| Mixed Models Analysis | Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. | 0.6578 | Mean Difference (Final Values) | -0.008 | Standard Error of the Mean | 0.017 | 95 | -0.042 | 0.027 | Olo 10 mcg qd minus Olo 5 mcg qd | No | Superiority or Other |
| Mixed Models Analysis | Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. | 0.0175 | Mean Difference (Final Values) | 0.042 | Standard Error of the Mean | 0.018 | 95 | 0.008 | 0.077 | Olo 5 mcg bid minus Olo 2 mcg bid | No | Superiority or Other |
| Mixed Models Analysis |
Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. |
| 0.2875 |
| Mean Difference (Final Values) |
| -0.021 |
| Standard Error of the Mean |
| 0.020 |
| 95 |
| -0.060 |
| 0.018 |
Olo 5 mcg qd minus Olo 5 mcg bid |
| No |
| Superiority or Other |
| Mixed Models Analysis | Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. | 0.4553 | Mean Difference (Final Values) | 0.015 | Standard Error of the Mean | 0.020 | 95 | -0.024 | 0.054 | Olo 5 mcg qd minus Olo 2 mcg bid | No | Superiority or Other |
| Mixed Models Analysis | Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. | 0.2902 | Mean Difference (Final Values) | -0.021 | Standard Error of the Mean | 0.020 | 95 | -0.060 | 0.018 | Olo 10 mcg qd minus Olo 5 mcg qd | No | Superiority or Other |
| Mixed Models Analysis | Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. | 0.0731 | Mean Difference (Final Values) | 0.036 | Standard Error of the Mean | 0.020 | 95 | -0.003 | 0.075 | Olo 5 mcg bid minus Olo 2 mcg bid | No | Superiority or Other |
| Mixed Models Analysis |
Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. |
| 0.1273 |
| Mean Difference (Final Values) |
| 0.041 |
| Standard Error of the Mean |
| 0.027 |
| 95 |
| -0.012 |
| 0.095 |
Olo 5 mcg qd minus Olo 5 mcg bid |
| No |
| Superiority or Other |
| Mixed Models Analysis | Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. | 0.0080 | Mean Difference (Final Values) | 0.073 | Standard Error of the Mean | 0.027 | 95 | 0.019 | 0.127 | Olo 5 mcg qd minus Olo 2 mcg bid | No | Superiority or Other |
| Mixed Models Analysis | Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. | 0.8683 | Mean Difference (Final Values) | 0.004 | Standard Error of the Mean | 0.027 | 95 | -0.049 | 0.058 | Olo 10 mcg qd minus Olo 5 mcg qd | No | Superiority or Other |
| Mixed Models Analysis | Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. | 0.2444 | Mean Difference (Final Values) | 0.032 | Standard Error of the Mean | 0.027 | 95 | -0.022 | 0.086 | Olo 5 mcg bid minus Olo 2 mcg bid | No | Superiority or Other |
| Mixed Models Analysis |
Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. |
| 0.0015 |
| Mean Difference (Final Values) |
| -0.103 |
| Standard Error of the Mean |
| 0.032 |
| 95 |
| -0.165 |
| -0.040 |
Olo 5 mcg qd minus Olo 5 mcg bid |
| No |
| Superiority or Other |
| Mixed Models Analysis | Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. | 0.4508 | Mean Difference (Final Values) | -0.024 | Standard Error of the Mean | 0.032 | 95 | -0.087 | 0.039 | Olo 5 mcg qd minus Olo 2 mcg bid | No | Superiority or Other |
| Mixed Models Analysis | Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. | 0.9087 | Mean Difference (Final Values) | 0.004 | Standard Error of the Mean | 0.032 | 95 | -0.059 | 0.066 | Olo 10 mcg qd minus Olo 5 mcg qd | No | Superiority or Other |
| Mixed Models Analysis | Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. | 0.0146 | Mean Difference (Final Values) | 0.079 | Standard Error of the Mean | 0.032 | 95 | 0.016 | 0.142 | Olo 5 mcg bid minus Olo 2 mcg bid | No | Superiority or Other |
| Mixed Models Analysis |
Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. |
| 0.2638 |
| Mean Difference (Final Values) |
| -0.030 |
| Standard Error of the Mean |
| 0.027 |
| 95 |
| -0.084 |
| 0.023 |
Olo 5 mcg qd minus Olo 5 mcg bid |
| No |
| Superiority or Other |
| Mixed Models Analysis | Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. | 0.3386 | Mean Difference (Final Values) | 0.026 | Standard Error of the Mean | 0.027 | 95 | -0.028 | 0.080 | Olo 5 mcg qd minus Olo 2 mcg bid | No | Superiority or Other |
| Mixed Models Analysis | Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. | 0.8877 | Mean Difference (Final Values) | 0.004 | Standard Error of the Mean | 0.027 | 95 | -0.050 | 0.057 | Olo 10 mcg qd minus Olo 5 mcg qd | No | Superiority or Other |
| Mixed Models Analysis | Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. | 0.0402 | Mean Difference (Final Values) | 0.057 | Standard Error of the Mean | 0.027 | 95 | 0.003 | 0.111 | Olo 5 mcg bid minus Olo 2 mcg bid | No | Superiority or Other |
| Mixed Models Analysis |
Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. |
| 0.0450 |
| Mean Difference (Final Values) |
| 0.068 |
| Standard Error of the Mean |
| 0.034 |
| 95 |
| 0.002 |
| 0.135 |
Olo 5 mcg qd minus Olo 5 mcg bid |
| No |
| Superiority or Other |
| Mixed Models Analysis | Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. | 0.0078 | Mean Difference (Final Values) | 0.092 | Standard Error of the Mean | 0.034 | 95 | 0.025 | 0.159 | Olo 5 mcg qd minus Olo 2 mcg bid | No | Superiority or Other |
| Mixed Models Analysis | Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. | 0.6268 | Mean Difference (Final Values) | 0.016 | Standard Error of the Mean | 0.034 | 95 | -0.050 | 0.083 | Olo 10 mcg qd minus Olo 5 mcg qd | No | Superiority or Other |
| Mixed Models Analysis | Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. | 0.4891 | Mean Difference (Final Values) | 0.024 | Standard Error of the Mean | 0.034 | 95 | -0.044 | 0.091 | Olo 5 mcg bid minus Olo 2 mcg bid | No | Superiority or Other |
| Mixed Models Analysis |
Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. |
| 0.9190 |
| Mean Difference (Final Values) |
| -0.004 |
| Standard Error of the Mean |
| 0.039 |
| 95 |
| -0.082 |
| 0.074 |
Olo 5 mcg qd minus Olo 5 mcg bid |
| No |
| Superiority or Other |
| Mixed Models Analysis | Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. | 0.0985 | Mean Difference (Final Values) | 0.066 | Standard Error of the Mean | 0.040 | 95 | -0.012 | 0.145 | Olo 5 mcg qd minus Olo 2 mcg bid | No | Superiority or Other |
| Mixed Models Analysis | Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. | 0.6991 | Mean Difference (Final Values) | -0.015 | Standard Error of the Mean | 0.039 | 95 | -0.093 | 0.063 | Olo 10 mcg qd minus Olo 5 mcg qd | No | Superiority or Other |
| Mixed Models Analysis | Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject. | 0.0802 | Mean Difference (Final Values) | 0.070 | Standard Error of the Mean | 0.040 | 95 | -0.009 | 0.149 | Olo 5 mcg bid minus Olo 2 mcg bid | No | Superiority or Other |
| Investigations |
|