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The primary objective of this study is to assess the efficacy (bronchoprotection) and safety of single doses of BI 1744 CL inhalation solution (2, 5, 10 and 20 mcg) delivered via the Respimat® inhaler, in patients with intermittent asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olodaterol (BI1744) Low | Experimental | Single dosing of low dose Olodaterol inhaled orally from Respimat Device |
|
| Olodaterol (BI1744) Medium Low | Experimental | Single dosing of medium low dose Olodaterol inhaled orally from Respimat Device |
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| Olodaterol (BI1744) Medium High | Experimental | Single dosing of medium high dose Olodaterol inhaled orally from Respimat Device |
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| Olodaterol (BI 1744) High | Experimental | Single dosing of high dose Olodaterol inhaled orally from Respimat Device |
|
| Placebo | Placebo Comparator | Single dosing of Olodaterol placebo inhaled orally from Respimat Device |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo device for comparison |
| |
| Olodaterol (BI1744CL) |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 24 Hours | Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 24 hours | 24 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 30 Minutes | Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 30 minutes | 30 minutes post dose |
| Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 4 Hours |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1222.4.103 UBC - Respiratory Medicine | Vancouver | British Columbia | Canada | |||
| 1222.4.104 Department of Medicine, Health Sciences Centre |
One patient was randomized, but the trial was put on hold so that the patient had to be discontinued and re-randomized. This causes a discrepancy between the 32 patients enrolled and the 31 patients reported for the participant flow.
This was a randomised, double-blind, placebo-controlled, 5-way crossover trial. The duration of each treatment period was 1 day with a 14 day washout period between treatments.
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| ID | Title | Description |
|---|---|---|
| FG000 | Olo 5mcg / Olo 2mcg / Olo 10mcg / Placebo / Olo 20mcg | Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 2 mcg qd in the second period, Olodaterol 10 mcg qd in the third period, matching Placebo in the fourth period and Olodaterol 20 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Olodaterol comparison of low, medium low, medium high and high doses |
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| Olodaterol (BI1744CL) | Drug | Olodaterol comparison of low, medium low, medium high and high doses |
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| Olodaterol (BI1744CL) | Drug | Olodaterol comparison of low, medium low, medium high and high doses |
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| Olodaterol (BI1744CL) | Drug | Olodaterol comparison of low, medium low, medium high and high doses |
|
Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 4 hours |
| 4 hours post dose |
| Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 8 Hours | Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 8 hours | 8 hours post dose |
| Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 32 Hours | Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 32 hours | 32 hours post dose |
| 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). | 5 days |
| Laboratory Testing: Average Change From Baseline of Potassium and Calcium | Laboratory testing: Average change from baseline of potassium and calcium measured on test-days | Baseline to Visit 6 |
| Hamilton |
| Ontario |
| Canada |
| 1222.4.101 2725 Chemin Ste Foy | Sainte-Foy | Quebec | Canada |
| 1222.4.102 | Saskatoon | Saskatchewan | Canada |
| FG001 |
| Olo 10mcg / Olo 20mcg / Olo 2mcg / Olo 5mcg / Placebo |
Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 20 mcg qd in the second period, Olodaterol 2 mcg qd in the third period, Olodaterol 5 mcg qd in the fourth period and matching Placebo in the fifth period. Olodaterol was administered via the Respimat inhaler. |
| FG002 | Olo 2mcg / Placebo / Olo 20mcg / Olo 10mcg / Olo 5mcg | Patients were administered Olodaterol 2 mcg qd in the first period, matching Placebo in the second period, Olodaterol 20 mcg qd in the third period, Olodaterol 10 mcg qd in the fourth period and Olodaterol 5 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler. |
| FG003 | Olo 20mcg / Olo 5mcg / Placebo / Olo 2mcg / Olo 10mcg | Patients were administered Olodaterol 20 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, matching Placebo in the third period, Olodaterol 2 mcg qd in the fourth period and Olodaterol 10 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler. |
| FG004 | Placebo / Olo 10mcg / Olo 5mcg / Olo 20mcg / Olo 2mcg | Patients were administered matching Placebo in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 5 mcg qd in the third period, Olodaterol 20 mcg qd in the fourth period and Olodaterol 2 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Total | Total number of patients treated in the study. This was a randomised, double-blind, placebo-controlled, 5-way crossover trial. 31 patients were assigned randomly to one of 5 treatment sequences in which they received each of 5 treatments. The duration of each treatment period was 1 day with a 14 day washout period between treatments. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 24 Hours | Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 24 hours | Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint. | Posted | Least Squares Mean | Standard Error | Log base 2 (mg/ml) | 24 hours post dose |
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| Secondary | Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 30 Minutes | Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 30 minutes | Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint. | Posted | Least Squares Mean | Standard Error | Log base 2 (mg/ml) | 30 minutes post dose |
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| Secondary | Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 4 Hours | Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 4 hours | Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint. | Posted | Least Squares Mean | Standard Error | Log base 2 (mg/ml) | 4 hours post dose |
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| Secondary | Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 8 Hours | Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 8 hours | Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint. | Posted | Least Squares Mean | Standard Error | Log base 2 (mg/ml) | 8 hours post dose |
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| Secondary | Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 32 Hours | Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 32 hours | Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint. | Posted | Least Squares Mean | Standard Error | Log base 2 (mg/ml) | 32 hours post dose |
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| 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). | The safety set included all patients who received any study medication. | Posted | Number | percentage of participants | 5 days |
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| 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 | All patients in the Safety set who have a baseline value and post dose values for each planned time. | Posted | Geometric Mean | Inter-Quartile Range | mmol/L | Baseline to Visit 6 |
|
2 weeks
Single dose including washout phase
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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 | Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler. | 0 | 29 | 4 | 29 | ||
| EG001 | Olo 2 mcg | Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler. | 0 | 28 | 1 | 28 | ||
| EG002 | Olo 5 mcg | Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler. | 0 | 28 | 1 | 28 | ||
| EG003 | Olo 10 mcg | Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler. | 0 | 30 | 1 | 30 | ||
| EG004 | Olo 20 mcg | Olodaterol 20 mcg qd delivered by the Respimat Inhaler. | 0 | 29 | 4 | 29 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
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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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C549647 | olodaterol |
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| Mixed Models Analysis |
Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects) |
| <0.0001 |
| Mean Difference (Final Values) |
| 1.711 |
| Standard Error of the Mean |
| 0.255 |
| 2-Sided |
| 95 |
| 1.205 |
| 2.217 |
Olo 5 mcg minus Placebo |
| No |
| Superiority or Other |
| Mixed Models Analysis | Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects) | <0.0001 | Mean Difference (Final Values) | 2.443 | Standard Error of the Mean | 0.248 | 2-Sided | 95 | 1.952 | 2.935 | Olo 10 mcg minus Placebo | No | Superiority or Other |
| Mixed Models Analysis | Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects) | <0.0001 | Mean Difference (Final Values) | 2.984 | Standard Error of the Mean | 0.251 | 2-Sided | 95 | 2.486 | 3.483 | Form 20 mcg minus Placebo | No | Superiority or Other |
| OG004 |
| Olodaterol (Olo) 20 mcg qd |
Olodaterol 20 mcg qd delivered by the Respimat Inhaler. |
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| OG004 |
| Olodaterol (Olo) 20 mcg qd |
Olodaterol 20 mcg qd delivered by the Respimat Inhaler. |
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| OG004 |
| Olodaterol (Olo) 20 mcg qd |
Olodaterol 20 mcg qd delivered by the Respimat Inhaler. |
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| OG004 |
| Olodaterol (Olo) 20 mcg qd |
Olodaterol 20 mcg qd delivered by the Respimat Inhaler. |
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| Olo 20 mcg |
Olodaterol 20 mcg qd delivered by the Respimat Inhaler. |
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Olodaterol 20 mcg qd delivered by the Respimat Inhaler. |
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