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To investigate the effectiveness and safety of BI 671800 given in the morning (AM), evening (PM) or twice daily (b.i.d.) compared too placebo as add on therapy to inhaled corticosteroid in symptomatic asthma patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 671800 AM and PM | Experimental | Patients receiving two capsules twice daily |
|
| BI 671800 AM | Experimental | Patients receiving four capsules in the morning |
|
| BI 671800 PM | Experimental | Patients receiving four capsules in the evening |
|
| Placebo | Placebo Comparator | Patients receiving four capsules twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 671800 | Drug | BI 671800 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline of Trough Forced Expiratory Volume in One Second (FEV1) Percent Predicted After 4 Weeks of Treatment | Trough FEV1 percent (%) predicted was defined as the mean of the morning and the evening FEV1 % predicted daily trough value at the end of the dosing interval. For the morning (evening) measurements, when FEV1 % predicted was available at both 25 minutes and 10 minutes prior to morning (evening) test-drug inhalation, morning (evening) trough FEV1 % predicted was the mean of these two morning (evening) pre-inhalation measurements. Trough FEV1 % predicted change from baseline after 4 weeks of treatment was defined as the change from baseline in the mean of the morning and the evening trough FEV1 % predicted. | At baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Asthma Control Questionnaire (ACQ) Mean Score After Four Weeks of Treatment | The Asthma Control Questionnaire (ACQ) consists of 6 patient self-evaluated questions and 1 by clinical staff with each question in 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of less than or equal to 0.75 indicate well-controlled asthma, scores between 0.76 and less than 1.5 indicate partly controlled asthma, and a score greater than or equal to 1.5 indicates uncontrolled asthma. |
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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 |
|---|---|---|---|---|---|---|
| 1268.53.01013 Boehringer Ingelheim Investigational Site | Huntington Beach | California | United States | |||
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| Label | URL |
|---|---|
| Related Info | View source |
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All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
This randomised, double-blind, placebo-controlled, cross-over study was to investigate efficacy and safety of 3×4-week treatment periods of oral BI 671800 Ethylenediamine 200 milligram (mg) twice or 400 mg once daily administered in the morning or evening, in symptomatic asthma patients on inhaled fluticasone propionate Metered Dose Inhaler.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo(A)/BI 671800 400mg AM QD (B)/BI 671800 400mg PM QD (C) | (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
|
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| Placebo |
| Drug |
Placebo matching BI 671800 |
|
| At baseline and 4 weeks |
| 1268.53.01014 Boehringer Ingelheim Investigational Site |
| Mission Viejo |
| California |
| United States |
| 1268.53.01002 Boehringer Ingelheim Investigational Site | Stockton | California | United States |
| 1268.53.01009 Boehringer Ingelheim Investigational Site | Colorado Springs | Colorado | United States |
| 1268.53.01011 Boehringer Ingelheim Investigational Site | Denver | Colorado | United States |
| 1268.53.01001 Boehringer Ingelheim Investigational Site | North Dartmouth | Massachusetts | United States |
| 1268.53.01005 Boehringer Ingelheim Investigational Site | Minneapolis | Minnesota | United States |
| 1268.53.01006 Boehringer Ingelheim Investigational Site | St Louis | Missouri | United States |
| 1268.53.01007 Boehringer Ingelheim Investigational Site | Raleigh | North Carolina | United States |
| 1268.53.01010 Boehringer Ingelheim Investigational Site | Portland | Oregon | United States |
| 1268.53.01003 Boehringer Ingelheim Investigational Site | Charleston | South Carolina | United States |
| 1268.53.01008 Boehringer Ingelheim Investigational Site | El Paso | Texas | United States |
| 1268.53.01012 Boehringer Ingelheim Investigational Site | San Antonio | Texas | United States |
| 1268.53.01015 Boehringer Ingelheim Investigational Site | Richmond | Virginia | United States |
| FG001 | Placebo(A)/BI 671800 400mg AM QD (B)/BI 671800 200 mg BID (D) | (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks. |
| FG002 | Placebo(A)/BI 671800 400mg PM QD (C)/BI 671800 400mg AM QD (B) | (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks. |
| FG003 | Placebo (A)/BI 671800 400mg PM QD (C)/BI 671800 200 mg BID (D) | (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks. |
| FG004 | Placebo(A)/BI 671800 200 mg BID(D)/BI 671800 400 mg AM QD(B) | (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks. |
| FG005 | Placebo(A)/BI 671800 200 mg BID(D)/BI 671800 400 mg PM QD(C) | (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks. |
| FG006 | BI 671800 400 mg AM QD(B)/Placebo(A)/BI 671800 400 mg PM QD(C) | (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks. |
| FG007 | BI 671800 400 mg AM QD(B)/Placebo(A)/BI 671800 200 mg BID(D) | (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks. |
| FG008 | BI 671800 400 mg AM QD(B)/BI 671800 400 mg PM QD(C)/Placebo(A) | (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks. |
| FG009 | BI 671800 400 mg AM QD(B)/BI 671800 200 mg BID(D)/Placebo(A) | (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks. |
| FG010 | BI 671800 400 mg PM QD(C)/Placebo(A)/BI 671800 400 mg AM QD(B) | (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks. |
| FG011 | BI 671800 400 mg PM QD(C)/Placebo(A)/BI 671800 200 mg BID(D) | (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks. |
| FG012 | BI 671800 400 mg PM QD(C)/BI 671800 400 mg AM QD(B)/Placebo(A) | (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks. |
| FG013 | BI 671800 400 mg PM QD(C)/BI 671800 200 mg BID(D)/Placebo(A) | (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks. |
| FG014 | BI 671800 200 mg BID(D)/Placebo(A)/BI 671800 400 mg AM QD(B) | (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks. |
| FG015 | BI 671800 200 mg BID(D)/Placebo(A)/BI 671800 400 mg PM QD(C) | (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks. |
| FG016 | BI 671800 200 mg BID(D)/BI 671800 400 mg AM QD(B)/Placebo(A) | (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks. |
| FG017 | BI 671800 200 mg BID(D)/BI 671800 400 mg PM QD(C)/Placebo(A) | (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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|
| Period 2 |
|
|
| Period 3 |
|
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Treated set: All patients treated with at least one dose of blinded study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Population | All of the enrolled participants that were randomized to one of the treatment sequences for 3 × 4-week treatment periods and treated with at least one dose of study drug. |
| 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 |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Trough forced expiratory volume in one second (FEV1) percent predicted | Baseline trough FEV1 percent (%) predicted was defined as the mean of FEV1 % predicted trough values taken at 25 minutes and 10 minutes prior to the first dose of randomized treatment. | Treated set: All patients treated with at least one dose of blinded study drug. Participants in treated set with non-missing baseline (Week 0) trough FEV1 percent predicted values were included. | Mean | Standard Deviation | Percentage of predicted trough FEV1 |
|
| 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 | Change From Baseline of Trough Forced Expiratory Volume in One Second (FEV1) Percent Predicted After 4 Weeks of Treatment | Trough FEV1 percent (%) predicted was defined as the mean of the morning and the evening FEV1 % predicted daily trough value at the end of the dosing interval. For the morning (evening) measurements, when FEV1 % predicted was available at both 25 minutes and 10 minutes prior to morning (evening) test-drug inhalation, morning (evening) trough FEV1 % predicted was the mean of these two morning (evening) pre-inhalation measurements. Trough FEV1 % predicted change from baseline after 4 weeks of treatment was defined as the change from baseline in the mean of the morning and the evening trough FEV1 % predicted. | Full analysis set (FAS): All patients randomized, treated with at least one dose of blinded study drug, with a baseline Forced expiratory volume in one second (FEV1) value and at least one on-treatment trough FEV1 value. The FAS is the basis for the intention-to-treat analysis. Participants with non-missing endpoint measurements were included. | Posted | Mean | Standard Error | Percentage of predicted trough FEV1 | At baseline and 4 weeks |
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| Secondary | Change From Baseline in Asthma Control Questionnaire (ACQ) Mean Score After Four Weeks of Treatment | The Asthma Control Questionnaire (ACQ) consists of 6 patient self-evaluated questions and 1 by clinical staff with each question in 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of less than or equal to 0.75 indicate well-controlled asthma, scores between 0.76 and less than 1.5 indicate partly controlled asthma, and a score greater than or equal to 1.5 indicates uncontrolled asthma. | Full analysis set (FAS): All patients randomized, treated with at least one dose of blinded study drug, with a baseline Forced expiratory volume in one second (FEV1) value and at least one on-treatment trough FEV1 value. The FAS is the basis for the intention-to-treat analysis. Participants with non-missing endpoint measurements were included. | Posted | Mean | Standard Error | Score on a scale | At baseline and 4 weeks |
|
From first dose of study drug until 4 weeks thereafter, up to 4 weeks + 5 days for (serious) adverse events, up to 4 weeks + 2 weeks of follow-up for all-cause mortality.
Treated set: All patients treated with at least one dose of blinded study drug. Total number of participants per treatment is lower than the total started number of participants due to participants having left the sequence before being exposed to the respective treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (A) | (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks. | 0 | 104 | 0 | 104 | 4 | 104 |
| EG001 | BI 671800 400mg AM QD (B) | (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks. | 0 | 70 | 0 | 70 | 3 | 70 |
| EG002 | BI 671800 400mg PM QD (C) | (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks. | 0 | 68 | 0 | 68 | 5 | 68 |
| EG003 | BI 671800 200mg BID (D) | (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks. | 0 | 67 | 0 | 67 | 2 | 67 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000605880 | BI 671800 |
Not provided
Not provided
Not provided
| Adverse Event |
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| Protocol Violation |
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| Adverse Event |
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| Unknown or Not Reported |
|
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A compound symmetry covariance structure was used. | Mixed effect model | 0.1426 | Adjusted means difference | 0.670 | Standard Error of the Mean | 0.625 | 2-Sided | 95 | -0.563 | 1.903 | Adjusted means difference of BI 671800 400 mg PM QD (C) vs Placebo (A). | Superiority | One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha. |
| Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A compound symmetry covariance structure was used. | Mixed effect model | 0.3231 | Adjusted means difference | 0.281 | Standard Error of the Mean | 0.611 | 2-Sided | 95 | -0.924 | 1.486 | Adjusted means difference of BI 671800 400 mg AM QD (B) vs Placebo (A). | Superiority | One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha. |
| OG002 | BI 671800 400mg PM QD (C) | (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks. |
| OG003 | BI 671800 200mg BID (D) | (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks. |
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