Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-014551-80 | EudraCT Number | EudraCT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a 6 week study to assess the effect of BI 671800 in patients with asthma. It is a double blind, parallel arm trial testing the safety and efficacy of BI 671800. The main objective is to assess the effect on lung function. The study will also provide data on the pharmacokinetics of BI 671800.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 671800 | Experimental | Patients receive BI 671800 capsules twice daily |
|
| Montelukast | Active Comparator | Patients receive Montelukast encapsulated tablets once daily |
|
| Placebo | Placebo Comparator | Patients receive placebo capsules and/or encapsulated placebo tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 671800 | Drug | Double blind randomised parallel group study to assess efficacy and tolerability of BI 617800 in patients with symptomatic asthma |
|
| 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 Change in Score on a Scale 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 |
|---|---|---|---|---|---|---|
| 1268.16.01004 Boehringer Ingelheim Investigational Site | Denver | Colorado | United States | |||
| 1268.16.01001 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, multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to assess the efficacy and safety of oral BI 671800 ED 400 mg b.i.d., montelukast 10 mg q.d., or placebo in symptomatic asthma patients on Fluticasone propionate Hydrofluoralkane Metered Dose Inhaler (100μg b.i.d.).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Daily treatment with 4 oral capsules of BI 671800 Ethylenediamine (ED) placebo in the morning and 4 oral capsules of BI 671800 ED placebo plus 1 over-encapsulated montelukast placebo tablet in the evening, for a total treatment period of 6 weeks. |
| FG001 | BI 671800 400 mg Bid |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Patients receive placebo capsules and/or encapsulated tablets |
|
| Montelukast | Drug | Double blind randomised parallel group study to assess efficacy and tolerability of BI 671800 in patients with symptomatic asthma |
|
| Measurements at baseline (mean ACQ score obtained at Week 0) and at week 6 of treatment. |
| North Dartmouth |
| Massachusetts |
| United States |
| 1268.16.01006 Boehringer Ingelheim Investigational Site | Plymouth | Minnesota | United States |
| 1268.16.01003 Boehringer Ingelheim Investigational Site | Portland | Oregon | United States |
| 1268.16.01002 Boehringer Ingelheim Investigational Site | Charleston | South Carolina | United States |
| 1268.16.01005 Boehringer Ingelheim Investigational Site | El Paso | Texas | United States |
| 1268.16.43002 Boehringer Ingelheim Investigational Site | Feldbach | Austria |
| 1268.16.49018 Boehringer Ingelheim Investigational Site | Aschaffenburg | Germany |
| 1268.16.49014 Boehringer Ingelheim Investigational Site | Bamberg | Germany |
| 1268.16.49001 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 1268.16.49004 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 1268.16.49010 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 1268.16.49012 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 1268.16.49013 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 1268.16.49016 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 1268.16.49008 Boehringer Ingelheim Investigational Site | Erfurt | Germany |
| 1268.16.49005 Boehringer Ingelheim Investigational Site | Frankfurt | Germany |
| 1268.16.49015 Boehringer Ingelheim Investigational Site | Frankfurt | Germany |
| 1268.16.49011 Boehringer Ingelheim Investigational Site | Hamburg | Germany |
| 1268.16.49009 Boehringer Ingelheim Investigational Site | Hanover | Germany |
| 1268.16.49017 Boehringer Ingelheim Investigational Site | Hanover | Germany |
| 1268.16.49007 Boehringer Ingelheim Investigational Site | Koblenz | Germany |
| 1268.16.49006 Boehringer Ingelheim Investigational Site | Lübeck | Germany |
| 1268.16.49002 Boehringer Ingelheim Investigational Site | Rüdersdorf | Germany |
| 1268.16.49003 Boehringer Ingelheim Investigational Site | Weinheim | Germany |
| 1268.16.39006 Boehringer Ingelheim Investigational Site | Ferrara | Italy |
| 1268.16.39007 Boehringer Ingelheim Investigational Site | Milan | Italy |
| 1268.16.39004 Boehringer Ingelheim Investigational Site | Pietra Ligure (SV) | Italy |
| 1268.16.39001 Boehringer Ingelheim Investigational Site | Pisa | Italy |
| 1268.16.64001 Boehringer Ingelheim Investigational Site | Christchurch NZ | New Zealand |
| 1268.16.64003 Boehringer Ingelheim Investigational Site | Greenlane East Auckland | New Zealand |
| 1268.16.82008 Boehringer Ingelheim Investigational Site | Anyang | South Korea |
| 1268.16.82009 Boehringer Ingelheim Investigational Site | Bucheon-si | South Korea |
| 1268.16.82007 Boehringer Ingelheim Investigational Site | Cheongju-si | South Korea |
| 1268.16.82006 Boehringer Ingelheim Investigational Site | Daegu | South Korea |
| 1268.16.82010 Boehringer Ingelheim Investigational Site | Gwangju | South Korea |
| 1268.16.82001 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1268.16.82002 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1268.16.82004 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1268.16.82005 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1268.16.82003 Boehringer Ingelheim Investigational Site | Suwon | South Korea |
| 1268.16.46002 Boehringer Ingelheim Investigational Site | Gothenburg | Sweden |
| 1268.16.46001 Boehringer Ingelheim Investigational Site | Lund | Sweden |
| 1268.16.46003 Boehringer Ingelheim Investigational Site | Örebro | Sweden |
| 1268.16.90002 Boehringer Ingelheim Investigational Site | Bursa | Turkey (Türkiye) |
| 1268.16.90003 Boehringer Ingelheim Investigational Site | Istanbul | Turkey (Türkiye) |
| 1268.16.90004 Boehringer Ingelheim Investigational Site | Istanbul | Turkey (Türkiye) |
| 1268.16.90006 Boehringer Ingelheim Investigational Site | Istanbul | Turkey (Türkiye) |
| 1268.16.90001 Boehringer Ingelheim Investigational Site | Mersin | Turkey (Türkiye) |
| 1268.16.44005 Boehringer Ingelheim Investigational Site | Chertsey | United Kingdom |
| 1268.16.44004 Boehringer Ingelheim Investigational Site | London | United Kingdom |
| 1268.16.44002 Boehringer Ingelheim Investigational Site | Manchester | United Kingdom |
| 1268.16.44003 Boehringer Ingelheim Investigational Site | Southampton | United Kingdom |
Daily treatment with 4 oral capsules of 100 milligram (mg) BI 67800 Ethylenediamine (ED) in the morning and 4 oral capsules of 100 mg BI 67800 ED plus 1 over-encapsulated montelukast placebo tablet in the evening, for a total treatment period of 6 weeks. |
| FG002 | Montelukast 10 mg qd | Daily treatment with 4 oral capsules of BI 67800 Ethylenediamine (ED) Placebo in the morning and 4 oral capsules of BI 67800 ED Placebo plus 1 table of 10 mg over-encapsulated montelukast in the evening, for a total treatment period of 6 weeks. |
| 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 BI 671800 Ethylenediamine (ED) placebo in the morning and 4 oral capsules of BI 671800 ED placebo plus 1 over-encapsulated montelukast placebo tablet in the evening, for a total treatment period of 6 weeks. |
| BG001 | BI 671800 400 mg Bid | Daily treatment with 4 oral capsules of 100 milligram (mg) BI 67800 Ethylenediamine (ED) in the morning and 4 oral capsules of 100 mg BI 67800 ED plus 1 over-encapsulated montelukast placebo tablet in the evening, for a total treatment period of 6 weeks. |
| BG002 | Montelukast 10 mg qd | Daily treatment with 4 oral capsules of BI 67800 Ethylenediamine (ED) Placebo in the morning and 4 oral capsules of BI 67800 ED Placebo plus 1 table of 10 mg over-encapsulated montelukast in the evening, for a total treatment period of 6 weeks. |
| BG003 | 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 randomized patients who received at least one dose of treatment and had both baseline and the post-baseline measurement at 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 Change in Score on a Scale 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 randomized patients who received at least one dose of treatment and had both baseline and the post-baseline measurement at 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 64 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 73 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 BI 671800 Ethylenediamine (ED) placebo in the morning and 4 oral capsules of BI 671800 ED placebo plus 1 over-encapsulated montelukast placebo tablet in the evening, for a total treatment period of 6 weeks. | 0 | 95 | 0 | 95 | 18 | 95 |
| EG001 | BI 671800 400 mg Bid | Daily treatment with 4 oral capsules of 100 milligram (mg) BI 67800 Ethylenediamine (ED) in the morning and 4 oral capsules of 100 mg BI 67800 ED plus 1 over-encapsulated montelukast placebo tablet in the evening, for a total treatment period of 6 weeks. | 0 | 81 | 1 | 81 | 10 | 81 |
| EG002 | Montelukast 10 mg qd | Daily treatment with 4 oral capsules of BI 67800 Ethylenediamine (ED) Placebo in the morning and 4 oral capsules of BI 67800 ED Placebo plus 1 table of 10 mg over-encapsulated montelukast in the evening, for a total treatment period of 6 weeks. | 0 | 67 | 0 | 67 | 8 | 67 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatitis toxic | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | 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 |
| C093875 | montelukast |
Not provided
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 |
|
| H0: Mean FEV1 % predicted trough change from baseline (Montelukast 10 mg qd) ≤ Mean FEV1 % predicted trough change from baseline (placebo) | 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. | 0.0657 | α=0.025 one-sided | Adjusted mean treatment differences | 2.369 | Standard Deviation | 1.567 | 95 | -0.713 | 5.452 | Superiority |
| H0: Mean FEV1 % predicted trough change from baseline (BI671800 ED 400 mg bid) ≤ Mean FEV1 % predicted trough change from baseline (Montelukast 10 mg qd) | 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. | 0.1748 | α=0.025 one-sided | Adjusted mean treatment differences | 1.501 | Standard Deviation | 1.602 | 2-Sided | 95 | -1.652 | 4.653 | Superiority |
| OG002 | Montelukast 10 mg qd | Daily treatment with 4 oral capsules of BI 67800 Ethylenediamine (ED) Placebo in the morning and 4 oral capsules of BI 67800 ED Placebo plus 1 table of 10 mg over-encapsulated montelukast in the evening, for a total treatment period of 6 weeks. |
|
|
|