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The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat inhaler once daily for 4 weeks in Japanese patients with chronic obstructive pulmonary disease (COPD). The selection of the optimum dose(s) will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1744 CL 5 µg | Experimental | 2 puffs of 2.5 µg/actuation |
|
| BI 1744 CL 10 µg | Experimental | 2 puffs of 5 µg/actuation |
|
| Placebo | Placebo Comparator | 2 puffs |
|
| BI 1744 CL 2 µg | Experimental | 2 puffs of 1 µg/actuation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1744 CL 2 µg | Drug | 2 puffs of 1 µg/actuation delivered by the Respimat® inhaler |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Trough FEV1 Response at Week 4 | The change from baseline in trough FEV1 after 4 weeks of treatment. Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to next test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline . Baseline trough FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 prior to administration of the first dose of study medication. | baseline and after 4 weeks treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Trough FEV1 Response at Week 2 | Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to next test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline in trough FEV1. Baseline trough FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 prior to administration of the first dose of study medication |
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Inclusion Criteria:
Exclusion Criteria:
Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may i) put the patient at risk because of participation in the study ii) influence the results of the study, or iii) cause concern regarding the patient's ability to participate in the study
Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an AST >80 IU/L, ALT >80 IU/L, bilirubin >1.5 x ULN or creatinine >1.5 x ULN will be excluded regardless of clinical condition (a repeat laboratory evaluation will not be conducted in these patients)
Patients with a history of asthma or a total blood eosinophil count >=600/mm3. A repeat eosinophil count will not be conducted in these patients
Patients with any of the following conditions:
Patients with any of the following conditions:
Patients who have undergone thoracotomy with pulmonary resection (patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1)
Patients being treated with any of the following concomitant medications:
Patients who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during clinic visits
Patients who have completed a pulmonary rehabilitation program in the 6 weeks prior to the screening visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program
Patients who have taken an investigational drug within 1 month or 6 half lives (whichever is greater) prior to screening visit
Patients with known hypersensitivity to beta-adrenergics drugs, BAC, EDTA or any other component of the Respimat inhalation solution delivery system
Pregnant or suspect of pregnant or women who are willing to become pregnant during the study period or nursing women
Patients who have previously been participated in this study or are currently participating in another study
Patients who are unable to comply with pulmonary medication restrictions prior to randomisation
The randomization of patients with any respiratory infection or COPD exacerbation in the 6 weeks prior to the screening visit or during the screening period should be postponed. Patients may be randomised 6 weeks following recovery from the infection or exacerbation
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1222.22.048 Boehringer Ingelheim Investigational Site | Asahikawa, Hokkaido | Japan | ||||
| 1222.22.044 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26316741 | Derived | Ichinose M, Takizawa A, Izumoto T, Tadayasu Y, Hamilton AL, Kunz C, Fukuchi Y. Efficacy and safety of the long-acting beta2-agonist olodaterol over 4 weeks in Japanese patients with chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2015 Aug 20;10:1673-83. doi: 10.2147/COPD.S86002. eCollection 2015. |
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Informed consent was obtained prior to patient participation in the trial, which included medication washout procedures or restrictions. Upon obtaining consent, the patients were instructed on the medication washout and other restrictions for the screening PFT (Visit 1).
The first patient was enrolled in the trial on 13 January 2009 and the last patient made the last visit on 31 March 2010. A total of 515 patients were enrolled in the trial at 48 trial sites. Of the 515 patients, 328 patients were entered in the trial and were randomly assigned to receive either one of the four treatments for 4 weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo |
| FG001 | Olodaterol 2mcg | Olodaterol 2mcg inhalation solution via Respimat |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| BI 1744 CL 5 µg |
| Drug |
2 puffs of 2.5 µg/actuation delivered by the Respimat® inhaler |
|
| BI 1744 CL 10 µg | Drug | 2 puffs of 5 µg/actuation delivered by Respimat® |
|
| Placebo | Drug | 2 puffs delivered by the Respimat® inhaler |
|
| baseline and after 2 weeks treatment |
| FEV1 AUC(0-3) Response at 4 Weeks | The change from baseline in FEV1 AUC(0-3) after 4 weeks of treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in liters. Due to normalization the unit is liters. | baseline and after 4 weeks treatment |
| FEV1 Peak(0-3) Response at 4 Weeks | The change from baseline in FEV1 peak(0-3) after 4 weeks of treatment. | baseline and after 4 weeks treatment |
| Trough FVC Response at Week 4 | The change from baseline in Trough FVC after 4 weeks of treatment | baseline and after 4 weeks treatment |
| FVC AUC(0-3) Response | The change from baseline in FVC AUC(0-3) response after 4 weeks of treatment. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in liters. Due to normalization the unit is liters. | baseline and after 4 weeks treatment |
| FVC Peak(0-3) Response | The change from baseline in FVC peak(0-3) response after 4 weeks of treatment. | baseline and after 4 weeks treatment |
| Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 0-6h (AUC 0-6h) Response After 4 Weeks | Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 0-6h was calculated from 0-6 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in liters. | baseline and after 4weeks treatment |
| Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 6-12 h (AUC 6-12h) Response After 4 Weeks | Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in liters. | Baseline and after 4weeks treatment |
| Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) After 4 Weeks | PEFR measurements were recorded by means of a patient diary on a daily basis. This diary was used to record the twice daily PEFs, Morning measurements were performed immediately upon arising before administration of trial and/or rescue medication.The highest of three readings for each measurement were recorded. | Week 4 |
| Weekly Mean Evening PEFR After 4 Weeks | PEFR measurements were recorded by means of a patient diary on a daily basis. This diary was used to record the twice daily PEFs, Evening measurements were performed at bedtime.The highest of three readings for each measurement were recorded. | Week 4 |
| Weekly Mean Number of Occasions of Rescue Therapy After 4 Weeks | Weekly mean number of occasions of rescue therapy used per day (PRN salbutamol ) | Week 4 |
| Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis, ECG and Physical Examination | Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis, ECG and Physical examination. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations). | 4 weeks |
| Difference From Baseline in Potassium | Difference from baseline in Potassium (normalized values). Normalization means that the values from different laboratories are transformed in such a way that they are directly comparable. | Baseline, Week 4 |
| Cmax (Maximum Measured Concentration of the Analyte in Plasma) | Cmax only calculated if >1/3 of the patients have available pharmacokinetic parameters,thus not applicable for the Olodaterol 2 mcg | after first inhalated administration |
| Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State) | Cmax,ss only calculated if >1/3 of the patients have available pharmacokinetic parameters, thus not applicable for the Olodaterol 2 mcg | visit at week 4 |
| AUC0-1 | Area under the concentration curve from 0 to 1 hour using trapezoid rule, only calculated if >1/3 of the patients have available pharmacokinetic parameters,thus not applicable for Olodaterol 2mcg group | after first inhalated administration |
| AUC0-1,ss | Area under the concentration curve from 0 to 1 hour at steady state using trapezoid rule, only calculated if >1/3 of the patients have available pharmacokinetic parameters, thus not applicable for Olodaterol 2mcg group | visit at week 4 |
| Bunkyo-ku, Tokyo |
| Japan |
| 1222.22.008 Boehringer Ingelheim Investigational Site | Chiba, Chiba | Japan |
| 1222.22.002 Boehringer Ingelheim Investigational Site | Fukuoka, Fukuoka | Japan |
| 1222.22.041 Boehringer Ingelheim Investigational Site | Fukuoka, Fukuoka | Japan |
| 1222.22.027 Boehringer Ingelheim Investigational Site | Himeji, Hyogo | Japan |
| 1222.22.028 Boehringer Ingelheim Investigational Site | Himeji, Hyogo | Japan |
| 1222.22.018 Boehringer Ingelheim Investigational Site | Hiroshima, Hiroshima | Japan |
| 1222.22.021 Boehringer Ingelheim Investigational Site | Hitachi, Ibaraki | Japan |
| 1222.22.010 Boehringer Ingelheim Investigational Site | Inashiki-gun, Ibaraki | Japan |
| 1222.22.012 Boehringer Ingelheim Investigational Site | Itabashi-ku, Tokyo | Japan |
| 1222.22.009 Boehringer Ingelheim Investigational Site | Kamogawa, Chiba | Japan |
| 1222.22.023 Boehringer Ingelheim Investigational Site | Kawasaki, Kanagawa | Japan |
| 1222.22.025 Boehringer Ingelheim Investigational Site | Kawasaki, Kanagawa | Japan |
| 1222.22.017 Boehringer Ingelheim Investigational Site | Kishiwada, Osaka | Japan |
| 1222.22.004 Boehringer Ingelheim Investigational Site | Kitakyusyu, Fukuoka | Japan |
| 1222.22.020 Boehringer Ingelheim Investigational Site | Koga, Fukuoka | Japan |
| 1222.22.014 Boehringer Ingelheim Investigational Site | Komaki, Aichi | Japan |
| 1222.22.032 Boehringer Ingelheim Investigational Site | Kumamoto, Kumamoto | Japan |
| 1222.22.005 Boehringer Ingelheim Investigational Site | Kurume, Fukuoka | Japan |
| 1222.22.029 Boehringer Ingelheim Investigational Site | Kurume, Fukuoka | Japan |
| 1222.22.033 Boehringer Ingelheim Investigational Site | Kyoto, Kyoto | Japan |
| 1222.22.050 Boehringer Ingelheim Investigational Site | Kyoto, Kyoto | Japan |
| 1222.22.022 Boehringer Ingelheim Investigational Site | Matsumoto, Nagano | Japan |
| 1222.22.015 Boehringer Ingelheim Investigational Site | Nagoya, Aichi | Japan |
| 1222.22.043 Boehringer Ingelheim Investigational Site | Nagoya, Aichi | Japan |
| 1222.22.001 Boehringer Ingelheim Investigational Site | Naka-gun, Ibaraki | Japan |
| 1222.22.007 Boehringer Ingelheim Investigational Site | Niigata, Niigata | Japan |
| 1222.22.040 Boehringer Ingelheim Investigational Site | Obihiro, Hokkaido | Japan |
| 1222.22.042 Boehringer Ingelheim Investigational Site | Okinawa, Okinawa | Japan |
| 1222.22.034 Boehringer Ingelheim Investigational Site | Osaka, Osaka | Japan |
| 1222.22.038 Boehringer Ingelheim Investigational Site | Osaka, Osaka | Japan |
| 1222.22.049 Boehringer Ingelheim Investigational Site | Osaka, Osaka | Japan |
| 1222.22.045 Boehringer Ingelheim Investigational Site | Osaka-sayama, Osaka | Japan |
| 1222.22.019 Boehringer Ingelheim Investigational Site | Sakai, Oasaka | Japan |
| 1222.22.006 Boehringer Ingelheim Investigational Site | Sapporo, Hokkaido | Japan |
| 1222.22.051 Boehringer Ingelheim Investigational Site | Sashima-gun, Ibaraki | Japan |
| 1222.22.031 Boehringer Ingelheim Investigational Site | Sendai, Miyagi | Japan |
| 1222.22.013 Boehringer Ingelheim Investigational Site | Seto, Aichi | Japan |
| 1222.22.024 Boehringer Ingelheim Investigational Site | Shibata-gun, Miyagi | Japan |
| 1222.22.003 Boehringer Ingelheim Investigational Site | Takarazuka, Hyogo | Japan |
| 1222.22.026 Boehringer Ingelheim Investigational Site | Tsukuba, Ibaraki | Japan |
| 1222.22.030 Boehringer Ingelheim Investigational Site | Ube, Yamaguchi | Japan |
| 1222.22.037 Boehringer Ingelheim Investigational Site | Uji, Kyoto | Japan |
| 1222.22.047 Boehringer Ingelheim Investigational Site | Wakayama, Wakayama | Japan |
| 1222.22.016 Boehringer Ingelheim Investigational Site | Yamagata, Yamagata | Japan |
| 1222.22.036 Boehringer Ingelheim Investigational Site | Yao, Osaka | Japan |
| 1222.22.011 Boehringer Ingelheim Investigational Site | Yokohama, Kanagawa | Japan |
| FG002 |
| Olodaterol 5mcg |
Olodaterol 5mcg inhalation solution via Respimat |
| FG003 | Olodaterol 10mcg | Olodaterol 10mcg inhalation solution via Respimat |
| COMPLETED |
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| NOT COMPLETED |
|
|
The treated set consisting of all randomised patients for whitch at least one investigational treatment was used.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo |
| BG001 | Olodaterol 2mcg | Olodaterol 2mcg inhalation solution via Respimat |
| BG002 | Olodaterol 5mcg | Olodaterol 5mcg inhalation solution via Respimat |
| BG003 | Olodaterol 10mcg | Olodaterol 10mcg inhalation solution via Respimat |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Percent predicted normal FEV1 | Based on Japanese equation | Mean | Standard Deviation | percent |
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| Percent predicted normal FEV1 | based on Japanese equation | Number | Participants |
|
| 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 | Trough FEV1 Response at Week 4 | The change from baseline in trough FEV1 after 4 weeks of treatment. Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to next test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline . Baseline trough FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 prior to administration of the first dose of study medication. | The full analysis set (FAS) for 4 weeks treatment period - analysis with imputation | Posted | Least Squares Mean | Standard Error | Liter | baseline and after 4 weeks treatment |
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| Secondary | Trough FEV1 Response at Week 2 | Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to next test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline in trough FEV1. Baseline trough FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 prior to administration of the first dose of study medication | The full analysis set (FAS) - analysis with imputation | Posted | Least Squares Mean | Standard Error | Liter | baseline and after 2 weeks treatment |
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| Secondary | FEV1 AUC(0-3) Response at 4 Weeks | The change from baseline in FEV1 AUC(0-3) after 4 weeks of treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in liters. Due to normalization the unit is liters. | The full analysis set (FAS) for 4 weeks treatment period - analysis with imputation | Posted | Least Squares Mean | Standard Error | Liter | baseline and after 4 weeks treatment |
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| Secondary | FEV1 Peak(0-3) Response at 4 Weeks | The change from baseline in FEV1 peak(0-3) after 4 weeks of treatment. | The full analysis set (FAS) for 4 weeks treatment period - analysis with imputation | Posted | Least Squares Mean | Standard Error | Liter | baseline and after 4 weeks treatment |
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| Secondary | Trough FVC Response at Week 4 | The change from baseline in Trough FVC after 4 weeks of treatment | The full analysis set (FAS) for 4 weeks treatment period - analysis with imputation | Posted | Least Squares Mean | Standard Error | Liter | baseline and after 4 weeks treatment |
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| Secondary | FVC AUC(0-3) Response | The change from baseline in FVC AUC(0-3) response after 4 weeks of treatment. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in liters. Due to normalization the unit is liters. | The full analysis set (FAS) for 4 weeks treatment period - analysis with imputation | Posted | Least Squares Mean | Standard Error | Liter | baseline and after 4 weeks treatment |
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| Secondary | FVC Peak(0-3) Response | The change from baseline in FVC peak(0-3) response after 4 weeks of treatment. | The full analysis set (FAS) for 4 weeks treatment period - analysis with imputation | Posted | Least Squares Mean | Standard Error | Liter | baseline and after 4 weeks treatment |
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| Secondary | Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 0-6h (AUC 0-6h) Response After 4 Weeks | Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 0-6h was calculated from 0-6 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in liters. | The full analysis set (FAS) for 4 weeks treatment period which is however restricted to patients with evaluable data for this endpoint - analysis with imputation | Posted | Least Squares Mean | Standard Error | Liter | baseline and after 4weeks treatment |
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| Secondary | Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 6-12 h (AUC 6-12h) Response After 4 Weeks | Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect. FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in liters. | The full analysis set (FAS) for 4 weeks treatment period which is however restricted to patients with evaluable data for this endpoint - analysis with imputation | Posted | Least Squares Mean | Standard Error | Liter | Baseline and after 4weeks treatment |
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| Secondary | Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) After 4 Weeks | PEFR measurements were recorded by means of a patient diary on a daily basis. This diary was used to record the twice daily PEFs, Morning measurements were performed immediately upon arising before administration of trial and/or rescue medication.The highest of three readings for each measurement were recorded. | The full analysis set (FAS) for 4 weeks treatment period which is however restricted to patients with evaluable data for this endpoint - analysis with imputation | Posted | Least Squares Mean | Standard Error | Liter/minute | Week 4 |
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| Secondary | Weekly Mean Evening PEFR After 4 Weeks | PEFR measurements were recorded by means of a patient diary on a daily basis. This diary was used to record the twice daily PEFs, Evening measurements were performed at bedtime.The highest of three readings for each measurement were recorded. | The full analysis set (FAS) for 4 weeks treatment period which is however restricted to patients with evaluable data for this endpoint - analysis with imputation | Posted | Least Squares Mean | Standard Error | Liter/minute | Week 4 |
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| Secondary | Weekly Mean Number of Occasions of Rescue Therapy After 4 Weeks | Weekly mean number of occasions of rescue therapy used per day (PRN salbutamol ) | The full analysis set (FAS) for 4 weeks treatment period which is however restricted to patients with evaluable data for this endpoint - analysis with imputation | Posted | Mean | Standard Error | Number of puffs | Week 4 |
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| 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, ECG and Physical examination. 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 | 4 weeks |
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| Secondary | Difference From Baseline in Potassium | Difference from baseline in Potassium (normalized values). Normalization means that the values from different laboratories are transformed in such a way that they are directly comparable. | Treated set. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Week 4 |
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| Secondary | Cmax (Maximum Measured Concentration of the Analyte in Plasma) | Cmax only calculated if >1/3 of the patients have available pharmacokinetic parameters,thus not applicable for the Olodaterol 2 mcg | Treated set which is however restricted to patients with evaluable data for this endpoint (Patients in which all plasma concentration values were below limit of quantification (BLQ), were excluded from the analysis and were not included into the total number of participants affected for this outcome measure) | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | after first inhalated administration |
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| Secondary | Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State) | Cmax,ss only calculated if >1/3 of the patients have available pharmacokinetic parameters, thus not applicable for the Olodaterol 2 mcg | Treated set which is however restricted to patients with evaluable data for this endpoint (Patients in which all plasma concentration values were below limit of quantification (BLQ), were excluded from the analysis and were not included into the total number of participants affected for this outcome measure) | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | visit at week 4 |
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| Secondary | AUC0-1 | Area under the concentration curve from 0 to 1 hour using trapezoid rule, only calculated if >1/3 of the patients have available pharmacokinetic parameters,thus not applicable for Olodaterol 2mcg group | Treated set which is however restricted to patients with evaluable data for this endpoint (Patients in which all plasma concentration values were below limit of quantification (BLQ), were excluded from the analysis and were not included into the total number of participants affected for this outcome measure) | Posted | Geometric Mean | Geometric Coefficient of Variation | pg*h/mL | after first inhalated administration |
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| Secondary | AUC0-1,ss | Area under the concentration curve from 0 to 1 hour at steady state using trapezoid rule, only calculated if >1/3 of the patients have available pharmacokinetic parameters, thus not applicable for Olodaterol 2mcg group | Treated set which is however restricted to patients with evaluable data for this endpoint (Patients in which all plasma concentration values were below limit of quantification (BLQ), were excluded from the analysis and were not included into the total number of participants affected for this outcome measure) | Posted | Geometric Mean | Geometric Coefficient of Variation | pg*h/mL | visit at week 4 |
|
|
4 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 | Placebo | Placebo | 2 | 79 | 7 | 79 | ||
| EG001 | Olodaterol 2mcg | Olodaterol 2mcg inhalation solution via Respimat | 3 | 84 | 9 | 84 | ||
| EG002 | Olodaterol 5mcg | Olodaterol 5mcg inhalation solution via Respimat | 1 | 79 | 3 | 79 | ||
| EG003 | Olodaterol 10mcg | Olodaterol 10mcg inhalation solution via Respimat | 3 | 86 | 5 | 86 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Meniere's disease | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| 30 to < 50% |
|
| 50% to 80% |
|
| ANCOVA |
| <0.0001 |
| Least Squares Mean for the difference |
| 0.132 |
| Standard Error of the Mean |
| 0.021 |
| 95 |
| 0.091 |
| 0.172 |
| No |
| Superiority or Other |
| Olodaterol 10mcg - Placebo | ANCOVA | <0.0001 | Least Squares Mean for the difference | 0.132 | Standard Error of the Mean | 0.020 | 95 | 0.092 | 0.172 | No | Superiority or Other |
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Olodaterol 10mcg inhalation solution via Respimat |
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Olodaterol 10mcg inhalation solution via Respimat |
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