Asthma Clinical Trial
Official title:
A Randomized, Double Blind, Placebo and Active Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of 6-week Treatment With Oral Doses of 50 mg b.i.d., 200 mg b.i.d., and 400 mg b.i.d. BI 671800 ED in Steroid-naïve Patients With Persistent Asthma
| Verified date | May 2022 |
| Source | Boehringer Ingelheim |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 389 |
| Est. completion date | March 26, 2011 |
| Est. primary completion date | March 26, 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | Inclusion criteria: 1. Signed informed consent consistent with ICH-GCP 2. Three month history of reversible (12% with 200 mL) asthma (according to GINA) with following spirometry at randomization: FEV1 60%-85%. 3. No ICS previous 3 months prior to screening. 4. Diagnosis of asthma prior to 40 years. 5. ACQ at least 1.5 at randomization. 6. Male or female, 18 to 65 years. 7. Non-smokers or ex-smokers ( less than 10 pack year history) with negative cotinine screen. 8. Able to perform PFT Exclusion criteria: 1. Significant diseases other than asthma or allergic rhinitis. 2. Hepatic transaminases or total bilirubin greater than 1.5 ULN. 3. Hospitalizations for asthma or asthma related intubation within 3 months. 4. Uncontrolled asthma. 5. Respiratory tract infection or exacerbation within 4 weeks. 6. FEV1 less than 40%, more than 12 puffs of SABA on more than two consecutive days or asthma exacerbation during the run-in period. 7. Participation in another interventional study. 8. Pregnant or nursing women. 9. Women of child bearing potential nor using appropriate methods of birth control as defined by protocol |
| Country | Name | City | State |
|---|---|---|---|
| Australia | 1268.17.61001 Boehringer Ingelheim Investigational Site | Adelaide | South Australia |
| 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 | 1268.17.02001 Boehringer Ingelheim Investigational Site | Quebec | |
| Canada | 1268.17.02004 Boehringer Ingelheim Investigational Site | Quebec | |
| Canada | 1268.17.02015 Boehringer Ingelheim Investigational Site | Sudbury | Ontario |
| Canada | 1268.17.02003 Boehringer Ingelheim Investigational Site | Toronto | Ontario |
| Canada | 1268.17.02013 Boehringer Ingelheim Investigational Site | Toronto | Ontario |
| Colombia | 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 | |
| Korea, Republic of | 1268.17.82007 Boehringer Ingelheim Investigational Site | Cheongju | |
| Korea, Republic of | 1268.17.82001 Boehringer Ingelheim Investigational Site | Seoul | |
| Korea, Republic of | 1268.17.82002 Boehringer Ingelheim Investigational Site | Seoul | |
| Korea, Republic of | 1268.17.82004 Boehringer Ingelheim Investigational Site | Seoul | |
| Korea, Republic of | 1268.17.82005 Boehringer Ingelheim Investigational Site | Seoul | |
| Korea, Republic of | 1268.17.82006 Boehringer Ingelheim Investigational Site | Seoul | |
| Korea, Republic of | 1268.17.82003 Boehringer Ingelheim Investigational Site | Suwon | |
| Korea, Republic of | 1268.17.82008 Boehringer Ingelheim Investigational Site | Wonju | |
| Mexico | 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 | |
| New Zealand | 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 | |
| Peru | 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 | |
| Philippines | 1268.17.63007 Boehringer Ingelheim Investigational Site | Caloocan City | |
| 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 | |
| Taiwan | 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 | |
| United States | 1268.17.01034 Boehringer Ingelheim Investigational Site | Baltimore | Maryland |
| United States | 1268.17.01008 Boehringer Ingelheim Investigational Site | Bellevue | Nebraska |
| United States | 1268.17.01022 Boehringer Ingelheim Investigational Site | Bozeman | Montana |
| United States | 1268.17.01007 Boehringer Ingelheim Investigational Site | Charleston | South Carolina |
| United States | 1268.17.01004 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio |
| United States | 1268.17.01015 Boehringer Ingelheim Investigational Site | Colorado Springs | Colorado |
| United States | 1268.17.01009 Boehringer Ingelheim Investigational Site | Cypress | California |
| United States | 1268.17.01019 Boehringer Ingelheim Investigational Site | Dallas | Texas |
| United States | 1268.17.01045 Boehringer Ingelheim Investigational Site | DeLand | Florida |
| United States | 1268.17.01001 Boehringer Ingelheim Investigational Site | Denver | Colorado |
| United States | 1268.17.01031 Boehringer Ingelheim Investigational Site | Easley | South Carolina |
| United States | 1268.17.01012 Boehringer Ingelheim Investigational Site | El Paso | Texas |
| 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 | 1268.17.01023 Boehringer Ingelheim Investigational Site | Houston | Texas |
| United States | 1268.17.01005 Boehringer Ingelheim Investigational Site | Iowa City | Iowa |
| United States | 1268.17.01048 Boehringer Ingelheim Investigational Site | Killeen | Texas |
| United States | 1268.17.01016 Boehringer Ingelheim Investigational Site | Lakewood | Colorado |
| United States | 1268.17.01006 Boehringer Ingelheim Investigational Site | Los Angeles | California |
| United States | 1268.17.01032 Boehringer Ingelheim Investigational Site | Minneapolis | Minnesota |
| United States | 1268.17.01028 Boehringer Ingelheim Investigational Site | New Braunfels | Texas |
| United States | 1268.17.01036 Boehringer Ingelheim Investigational Site | Normal | Illinois |
| 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 | 1268.17.01038 Boehringer Ingelheim Investigational Site | Oklahoma City | Oklahoma |
| United States | 1268.17.01040 Boehringer Ingelheim Investigational Site | Palmdale | California |
| United States | 1268.17.01042 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania |
| United States | 1268.17.01011 Boehringer Ingelheim Investigational Site | Raleigh | North Carolina |
| United States | 1268.17.01010 Boehringer Ingelheim Investigational Site | Saint Louis | Missouri |
| United States | 1268.17.01037 Boehringer Ingelheim Investigational Site | Saint Louis | Missouri |
| United States | 1268.17.01035 Boehringer Ingelheim Investigational Site | San Antonio | Texas |
| United States | 1268.17.01024 Boehringer Ingelheim Investigational Site | San Jose | California |
| United States | 1268.17.01025 Boehringer Ingelheim Investigational Site | South Bend | Indiana |
| United States | 1268.17.01049 Boehringer Ingelheim Investigational Site | Spartanburg | South Carolina |
| United States | 1268.17.01003 Boehringer Ingelheim Investigational Site | Stockton | California |
| United States | 1268.17.01047 Boehringer Ingelheim Investigational Site | Tacoma | Washington |
| United States | 1268.17.01043 Boehringer Ingelheim Investigational Site | Tucson | Arizona |
| United States | 1268.17.01033 Boehringer Ingelheim Investigational Site | Wheat Ridge | Colorado |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
United States, Australia, Canada, Colombia, Korea, Republic of, Mexico, New Zealand, Peru, Philippines, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. |
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. |
Measurements at baseline (mean ACQ score obtained at Week 0) and at week 6 of treatment. |
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