Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a 6 week study to investigate the effectiveness and safety of BI 671800 ED in patients with asthma who do not take inhaled corticosteroids.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 671800 (low dose) | Experimental | Patients receive BI 671800 (low dose) capsules twice daily |
|
| Fluticasone propionate | Active Comparator | Patients inhale from Fluticasone propionate metered dose inhaler (MDI) twice daily |
|
| Placebo | Placebo Comparator | Patients receive placebo capsules twice daily |
|
| BI 671800 (medium dose) | Experimental | Patients receive BI 671800 (medium dose) capsules twice daily |
|
| BI 671800 (high dose) | Experimental | Patients receive BI 671800 (high dose) capsules twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 671800 | Drug | BI 671800 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Forced Expiratory Volume in One Second (FEV1) % Predicted Trough Change From Baseline (Mean Observed in the 2 Weeks Prior to Treatment) After Six Weeks of Treatment | Forced expiratory volume in one second (FEV1) % predicted trough change from baseline (mean observed in the 2 weeks prior to treatment) after 6 weeks of treatment, where trough FEV1 % predicted was defined as the mean of the FEV1 % predicted trough values at 25 minutes and 10 minutes prior to dosing on clinic visit. MMRM in the statistical test comments is mixed effects model with repeated measures. | Measurements at baseline (mean observed in the 2 weeks prior to treatment) and at week 6 of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Control Questionnaire (ACQ) Mean Score Change From Baseline After Six Weeks of Treatment | Asthma Control Questionnaire (ACQ) mean score change from baseline (mean ACQ score obtained at Week 0) after six weeks of treatment. The Asthma Control Questionnaire (ACQ) is a patient-reported outcome questionnaire containing 7 items. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore between 0 (well controlled) and 6 (extremely poorly controlled) These questions based on recall of the previous 7 days comprise breathlessness, nocturnal waking, symptoms on waking, activity limitation, wheeze, frequency of short-acting beta-adrenergic (SABA) use, and categorized pre-bronchodilator FEV1% predicted. |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1268.17.01043 Boehringer Ingelheim Investigational Site | Tucson | Arizona | United States | |||
| 1268.17.01009 Boehringer Ingelheim Investigational Site |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct. Rescue medication was allowed for all subjects as required.
This was a Phase IIa multi-centre, multi-national, randomized, double-blind, placebo-controlled, parallel group, double-dummy study investigating the efficacy, safety and tolerability of BI 671800 ED (50, 200 and 400 mg b.i.d.) compared to fluticasone propionate 110 mcg 2 puffs b.i.d. and placebo in symptomatic steroid-naïve asthma patients.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Daily treatment with 4 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks. |
| FG001 | BI 671800 50 mg Bid |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fluticasone propionate placebo | Drug | Placebo matching Fluticasone propionate |
|
| Fluticasone propionate | Drug | Fluticasone propionate |
|
| BI 671800 Placebo | Drug | Placebo matching BI 671800 |
|
| Measurements at baseline (mean ACQ score obtained at Week 0) and at week 6 of treatment. |
| Cypress |
| California |
| United States |
| 1268.17.01006 Boehringer Ingelheim Investigational Site | Los Angeles | California | United States |
| 1268.17.01040 Boehringer Ingelheim Investigational Site | Palmdale | California | United States |
| 1268.17.01024 Boehringer Ingelheim Investigational Site | San Jose | California | United States |
| 1268.17.01003 Boehringer Ingelheim Investigational Site | Stockton | California | United States |
| 1268.17.01015 Boehringer Ingelheim Investigational Site | Colorado Springs | Colorado | United States |
| 1268.17.01001 Boehringer Ingelheim Investigational Site | Denver | Colorado | United States |
| 1268.17.01016 Boehringer Ingelheim Investigational Site | Lakewood | Colorado | United States |
| 1268.17.01033 Boehringer Ingelheim Investigational Site | Wheat Ridge | Colorado | United States |
| 1268.17.01045 Boehringer Ingelheim Investigational Site | DeLand | Florida | United States |
| 1268.17.01036 Boehringer Ingelheim Investigational Site | Normal | Illinois | United States |
| 1268.17.01025 Boehringer Ingelheim Investigational Site | South Bend | Indiana | United States |
| 1268.17.01005 Boehringer Ingelheim Investigational Site | Iowa City | Iowa | United States |
| 1268.17.01034 Boehringer Ingelheim Investigational Site | Baltimore | Maryland | United States |
| 1268.17.01014 Boehringer Ingelheim Investigational Site | North Dartmouth | Massachusetts | United States |
| 1268.17.01030 Boehringer Ingelheim Investigational Site | North Dartmouth | Massachusetts | United States |
| 1268.17.01027 Boehringer Ingelheim Investigational Site | Novi | Michigan | United States |
| 1268.17.01032 Boehringer Ingelheim Investigational Site | Minneapolis | Minnesota | United States |
| 1268.17.01010 Boehringer Ingelheim Investigational Site | St Louis | Missouri | United States |
| 1268.17.01037 Boehringer Ingelheim Investigational Site | St Louis | Missouri | United States |
| 1268.17.01022 Boehringer Ingelheim Investigational Site | Bozeman | Montana | United States |
| 1268.17.01008 Boehringer Ingelheim Investigational Site | Bellevue | Nebraska | United States |
| 1268.17.01011 Boehringer Ingelheim Investigational Site | Raleigh | North Carolina | United States |
| 1268.17.01004 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | United States |
| 1268.17.01038 Boehringer Ingelheim Investigational Site | Oklahoma City | Oklahoma | United States |
| 1268.17.01042 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | United States |
| 1268.17.01007 Boehringer Ingelheim Investigational Site | Charleston | South Carolina | United States |
| 1268.17.01031 Boehringer Ingelheim Investigational Site | Easley | South Carolina | United States |
| 1268.17.01039 Boehringer Ingelheim Investigational Site | Fort Mill | South Carolina | United States |
| 1268.17.01026 Boehringer Ingelheim Investigational Site | Greenville | South Carolina | United States |
| 1268.17.01029 Boehringer Ingelheim Investigational Site | Greenville | South Carolina | United States |
| 1268.17.01049 Boehringer Ingelheim Investigational Site | Spartanburg | South Carolina | United States |
| 1268.17.01019 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States |
| 1268.17.01012 Boehringer Ingelheim Investigational Site | El Paso | Texas | United States |
| 1268.17.01023 Boehringer Ingelheim Investigational Site | Houston | Texas | United States |
| 1268.17.01048 Boehringer Ingelheim Investigational Site | Killeen | Texas | United States |
| 1268.17.01028 Boehringer Ingelheim Investigational Site | New Braunfels | Texas | United States |
| 1268.17.01035 Boehringer Ingelheim Investigational Site | San Antonio | Texas | United States |
| 1268.17.01047 Boehringer Ingelheim Investigational Site | Tacoma | Washington | United States |
| 1268.17.61001 Boehringer Ingelheim Investigational Site | Adelaide | South Australia | Australia |
| 1268.17.02015 Boehringer Ingelheim Investigational Site | Greater Sudbury | Ontario | Canada |
| 1268.17.02012 Boehringer Ingelheim Investigational Site | Hawkesbury | Ontario | Canada |
| 1268.17.02010 Boehringer Ingelheim Investigational Site | Mississauga | Ontario | Canada |
| 1268.17.02014 Boehringer Ingelheim Investigational Site | Newmarket | Ontario | Canada |
| 1268.17.02003 Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada |
| 1268.17.02013 Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada |
| 1268.17.02001 Boehringer Ingelheim Investigational Site | Québec | Quebec | Canada |
| 1268.17.02004 Boehringer Ingelheim Investigational Site | Québec | Quebec | Canada |
| 1268.17.57003 Boehringer Ingelheim Investigational Site | Bogotá | Colombia |
| 1268.17.57004 Boehringer Ingelheim Investigational Site | Bogotá | Colombia |
| 1268.17.57002 Boehringer Ingelheim Investigational Site | Medellín | Colombia |
| 1268.17.52002 Boehringer Ingelheim Investigational Site | Cuernavaca | Mexico |
| 1268.17.52001 Boehringer Ingelheim Investigational Site | Monterrey | Mexico |
| 1268.17.52004 Boehringer Ingelheim Investigational Site | Toriello Guerra | Mexico |
| 1268.17.52003 Boehringer Ingelheim Investigational Site | Zona Río | Mexico |
| 1268.17.64001 Boehringer Ingelheim Investigational Site | Christchurch | New Zealand |
| 1268.17.64003 Boehringer Ingelheim Investigational Site | Greenlane East Auckland | New Zealand |
| 1268.17.64002 Boehringer Ingelheim Investigational Site | Newtown Wellington NZ | New Zealand |
| 1268.17.51003 Boehringer Ingelheim Investigational Site | Jesús María | Peru |
| 1268.17.51002 Boehringer Ingelheim Investigational Site | Lima | Peru |
| 1268.17.51006 Boehringer Ingelheim Investigational Site | San Borja | Peru |
| 1268.17.51004 Boehringer Ingelheim Investigational Site | San Isidro | Peru |
| 1268.17.51005 Boehringer Ingelheim Investigational Site | Santiago de Surco | Peru |
| 1268.17.51001 Boehringer Ingelheim Investigational Site | Urb. Ingeniería | Peru |
| 1268.17.63007 Boehringer Ingelheim Investigational Site | Caloocan | Philippines |
| 1268.17.63002 Boehringer Ingelheim Investigational Site | Manila | Philippines |
| 1268.17.63001 Boehringer Ingelheim Investigational Site | Quezon City | Philippines |
| 1268.17.63003 Boehringer Ingelheim Investigational Site | Quezon City | Philippines |
| 1268.17.63004 Boehringer Ingelheim Investigational Site | Quezon City | Philippines |
| 1268.17.63005 Boehringer Ingelheim Investigational Site | Quezon City | Philippines |
| 1268.17.63006 Boehringer Ingelheim Investigational Site | Quezon City | Philippines |
| 1268.17.82007 Boehringer Ingelheim Investigational Site | Cheongju-si | South Korea |
| 1268.17.82001 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1268.17.82002 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1268.17.82004 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1268.17.82005 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1268.17.82006 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1268.17.82003 Boehringer Ingelheim Investigational Site | Suwon | South Korea |
| 1268.17.82008 Boehringer Ingelheim Investigational Site | Wŏnju | South Korea |
| 1268.17.86210 Boehringer Ingelheim Investigational Site | Chiayi City | Taiwan |
| 1268.17.86211 Boehringer Ingelheim Investigational Site | Kaohsiung City | Taiwan |
| 1268.17.86207 Boehringer Ingelheim Investigational Site | Taichung | Taiwan |
| 1268.17.86208 Boehringer Ingelheim Investigational Site | Taichung | Taiwan |
| 1268.17.86209 Boehringer Ingelheim Investigational Site | Taichung | Taiwan |
| 1268.17.86201 Boehringer Ingelheim Investigational Site | Taipei | Taiwan |
| 1268.17.86202 Boehringer Ingelheim Investigational Site | Taipei | Taiwan |
| 1268.17.86203 Boehringer Ingelheim Investigational Site | Taipei | Taiwan |
| 1268.17.86204 Boehringer Ingelheim Investigational Site | Taipei | Taiwan |
| 1268.17.86205 Boehringer Ingelheim Investigational Site | Taipei | Taiwan |
| 1268.17.86206 Boehringer Ingelheim Investigational Site | Taipei | Taiwan |
| 1268.17.86200 Boehringer Ingelheim Investigational Site | Taoyuan County | Taiwan |
Daily treatment with 2 oral capsules of 25 milligram (mg) BI 671800 Ethylenediamine (ED), 2 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 2 oral capsules of 25 mg BI 671800 ED, 2 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks. |
| FG002 | BI 671800 200 mg Bid | Daily treatment with oral 2 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED), 2 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 2 oral capsules of 100 mg BI 671800 ED, 2 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks. |
| FG003 | BI 671800 400 mg Bid | Daily treatment with 4 oral capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of 100 mg BI 671800 ED and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks. |
| FG004 | Fluticasone 220 mcg Bid | Daily treatment with 4 oral capsules of Placebo and 2 puffs Fluticasone propionate metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of Placebo and 2 puffs Fluticasone propionate MDI 110 mcg in the evening, for a total treatment period of 6 weeks. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Daily treatment with 4 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks. |
| BG001 | BI 671800 50 mg Bid | Daily treatment with 2 oral capsules of 25 milligram (mg) BI 671800 Ethylenediamine (ED), 2 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 2 oral capsules of 25 mg BI 671800 ED, 2 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks. |
| BG002 | BI 671800 200 mg Bid | Daily treatment with oral 2 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED), 2 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 2 oral capsules of 100 mg BI 671800 ED, 2 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks. |
| BG003 | BI 671800 400 mg Bid | Daily treatment with 4 oral capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of 100 mg BI 671800 ED and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks. |
| BG004 | Fluticasone 220 mcg Bid | Daily treatment with 4 oral capsules of Placebo and 2 puffs Fluticasone propionate metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of Placebo and 2 puffs Fluticasone propionate MDI 110 mcg in the evening, for a total treatment period of 6 weeks. |
| BG005 | 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Percentage of predicted forced expiratory volume in one second (FEV1) | Mean | Standard Deviation | Percentage of predicted 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 | Forced Expiratory Volume in One Second (FEV1) % Predicted Trough Change From Baseline (Mean Observed in the 2 Weeks Prior to Treatment) After Six Weeks of Treatment | Forced expiratory volume in one second (FEV1) % predicted trough change from baseline (mean observed in the 2 weeks prior to treatment) after 6 weeks of treatment, where trough FEV1 % predicted was defined as the mean of the FEV1 % predicted trough values at 25 minutes and 10 minutes prior to dosing on clinic visit. MMRM in the statistical test comments is mixed effects model with repeated measures. | Statistical analysis was performed on the Full Analysis Set (FAS): Randomized patients who received at least one dose of treatment and had both baseline and at least one post-baseline measurement at or before 6 weeks for the primary efficacy variable. | Posted | Mean | Standard Deviation | FEV1 percent predicted | Measurements at baseline (mean observed in the 2 weeks prior to treatment) and at week 6 of treatment. |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Asthma Control Questionnaire (ACQ) Mean Score Change From Baseline After Six Weeks of Treatment | Asthma Control Questionnaire (ACQ) mean score change from baseline (mean ACQ score obtained at Week 0) after six weeks of treatment. The Asthma Control Questionnaire (ACQ) is a patient-reported outcome questionnaire containing 7 items. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore between 0 (well controlled) and 6 (extremely poorly controlled) These questions based on recall of the previous 7 days comprise breathlessness, nocturnal waking, symptoms on waking, activity limitation, wheeze, frequency of short-acting beta-adrenergic (SABA) use, and categorized pre-bronchodilator FEV1% predicted. | Statistical analysis was performed on the Full Analysis Set (FAS): Randomized patients who received at least one dose of treatment and had both baseline and at least one post-baseline measurement at or before 6 weeks for the primary efficacy variable. | Posted | Mean | Standard Deviation | Score on a scale | Measurements at baseline (mean ACQ score obtained at Week 0) and at week 6 of treatment. |
|
Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.
Treated Set (TS): All randomized patients who received at least one dose of treatment, the treated set was used in the safety analysis.
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 | Daily treatment with 4 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks. | 0 | 78 | 1 | 78 | 14 | 78 |
| EG001 | BI 671800 50 mg Bid | Daily treatment with 2 oral capsules of 25 milligram (mg) BI 671800 Ethylenediamine (ED), 2 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 2 oral capsules of 25 mg BI 671800 ED, 2 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks. | 0 | 77 | 0 | 77 | 15 | 77 |
| EG002 | BI 671800 200 mg Bid | Daily treatment with oral 2 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED), 2 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 2 oral capsules of 100 mg BI 671800 ED, 2 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks. | 0 | 83 | 0 | 83 | 9 | 83 |
| EG003 | BI 671800 400 mg Bid | Daily treatment with 4 oral capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of 100 mg BI 671800 ED and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks. | 0 | 79 | 1 | 79 | 14 | 79 |
| EG004 | Fluticasone 220 mcg Bid | Daily treatment with 4 oral capsules of Placebo and 2 puffs Fluticasone propionate metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of Placebo and 2 puffs Fluticasone propionate MDI 110 mcg in the evening, for a total treatment period of 6 weeks. | 0 | 71 | 0 | 71 | 11 | 71 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | 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 |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 200 mg b.i.d. compared with those treated with placebo, after 6 weeks. | Mixed Models Analysis | MMRM with baseline, treatment, day, trea | 0.0126 | α=0.025 one-sided | Adjusted mean treatment differences | 3.589 | Standard Deviation | 1.600 | 2-Sided | 95 | 0.447 | 6.732 | Superiority |
| Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 400 mg b.i.d. compared with those treated with placebo, after 6 weeks. | Mixed Models Analysis | MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect. | 0.0078 | α=0.025 one-sided | Adjusted mean treatment differences | 3.977 | Standard Deviation | 1.640 | 2-Sided | 95 | 0.756 | 7.197 | Superiority |
| Superiority in mean trough FEV1 % predicted change from baseline in patients treated with fluticasone propionate 110 mcg 2 puffs b.i.d. compared with those treated with placebo, after 6 weeks. | Mixed Models Analysis | MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect. | <.0001 | α=0.025 one-sided | Adjusted mean treatment differences | 8.619 | Standard Deviation | 1.684 | 2-Sided | 95 | 5.312 | 11.927 | Other |
| Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 50 mg b.i.d. compared with those treated with fluticasone propionate 220 mcg b.i.d., after 6 weeks. | Mixed Models Analysis | MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect. | 0.9996 | α=0.025 one-sided | Adjusted mean treatment differences | -5.536 | Standard Deviation | 1.653 | 2-Sided | 95 | -8.783 | -2.290 | Superiority |
| Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 200 mg b.i.d. compared with those treated with fluticasone propionate 220mcg b.i.d., after 6 weeks. | Mixed Models Analysis | MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect. | 0.9991 | α=0.025 one-sided | Adjusted mean treatment differences | -5.030 | Standard Deviation | 1.606 | 2-Sided | 95 | -8.185 | -1.875 | Superiority |
| Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 400 mg b.i.d. compared with those treated with fluticasone propionate 220 mcg b.i.d., after 6 weeks. | Mixed Models Analysis | MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect. | 0.9975 | α=0.025 one-sided | Adjusted mean treatment differences | -4.643 | Standard Deviation | 1.647 | 2-Sided | 95 | -7.877 | -1.408 | Superiority |
| OG002 | BI 671800 200 mg Bid | Daily treatment with oral 2 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED), 2 oral capsules of Placebo and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 2 oral capsules of 100 mg BI 671800 ED, 2 oral capsules of Placebo and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks. |
| OG003 | BI 671800 400 mg Bid | Daily treatment with 4 oral capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) and 2 puffs Placebo metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of 100 mg BI 671800 ED and 2 puffs Placebo MDI 110 mcg in the evening, for a total treatment period of 6 weeks. |
| OG004 | Fluticasone 220 mcg Bid | Daily treatment with 4 oral capsules of Placebo and 2 puffs Fluticasone propionate metered dose inhaler (MDI) 110 microgram (mcg) in the morning and 4 oral capsules of Placebo and 2 puffs Fluticasone propionate MDI 110 mcg in the evening, for a total treatment period of 6 weeks. |
|
|
|