Study on BI 54903 (Inhaled Corticosteroid) Administered Twice Daily Via Respimat Inhaler in Patients With Asthma Inadequately Controlled on Medium Dose Inhaled Corticosteroid (ICS).
NCT ID: NCT01396278
Last Updated: 2025-02-07
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
9 participants
INTERVENTIONAL
2011-07-01
2011-12-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BI 54903 low dose
patient to receive Respimat inhaler containing low dose BI 54903 plus placebo matching hydrofluoroalkane (HFA) metered dose inhaler (MDI)
Placebo
Placebo matching fluticasone propionate HFA MDI
BI 54903
BI 54903 via Respimat inhaler
BI 54903 medium dose
Respimat inhaler containing medium dose BI 54903 plus placebo matching HFA MDI
Placebo
Placebo matching fluticasone propionate HFA MDI
BI 54903
BI 54903 via Respimat inhaler
BI 54903 high dose
Respimat inhaler containing high dose BI 54903 plus placebo matching HFA MDI
Placebo
Placebo matching fluticasone propionate HFA MDI
BI 54903
BI 54903 via Respimat inhaler
Fluticasone propionate 440 mcg BID
Fluticasone HFA MDI containing 440 mcg ICS plus placebo matching Respimat inhaler
Fluticasone propionate
Fluticasone propionate HFA MDI
Fluticasone propionate 88 mcg BID
Fluticasone HFA MDI containing 88 mcg ICS plus placebo matching Respimat inhaler
Fluticasone propionate
Fluticasone propionate HFA MDI
Interventions
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Placebo
Placebo matching fluticasone propionate HFA MDI
Fluticasone propionate
Fluticasone propionate HFA MDI
BI 54903
BI 54903 via Respimat inhaler
Eligibility Criteria
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Inclusion Criteria
2. Male and female patients aged at least 12 to 65 years.
3. All patients must have a history of asthma diagnosed by a physician for at least three months at the time of enrolment into the trial according to the 2009 Global Initiative for Asthma (GINA) Guidelines. The initial diagnosis of asthma must have been made before the age of 40 years.
4. All patients must be on a maintenance treatment with high-dose ICS with long-acting beta 2-agonist (LABA), stable for at least six weeks prior to Visit 1
5. All patients must have a pre-bronchodilator FEV1 of not less than 60 to 90% of predicted normal and an ACQ-6 mean score of less than 1.5 at the pre-screening Visits 1and 2.
6. Patients must be never-smokers or ex-smokers with a smoking history of less than 10 pack-years and smoking cessation at least one year prior to screening .
7. Patients must be able to use Respimat® inhaler and MDI correctly
8. Patients must be able to perform all trial-related procedures including technically acceptable pulmonary function tests and electronic peak expiratory flow (PEF) measurements, and must be able to maintain records during the study period as required in the protocol.
To enter treatment period following additional criteria have to be met:
9. All patients must have an improvement in FEV1 not less than 12 % above baseline and an absolute change of at least 200 mL within 15-30 min after administration of 400 mcg salbutamol/albuterol HFA MDI as demonstrated at Visit 1 or during one of the visits during run-in period.
10. During the run-in period (at the same clinic visit) all patients must be both symptomatic (ACQ-6 mean score equal to or greater than 1.5) and have shown a decrease in morning pre-bronchodilator FEV1 not less than 10% and less than or equal to 25% from pre-screening baseline FEV1 at Visit 2.
Exclusion Criteria
2. Patients with a clinically relevant, abnormal screening haematology and/or blood chemistry finding, if the abnormality indicates a significant disease as defined in exclusion criterion no. 1.
3. Patients with a history of upper respiratory tract infection (URTI) or lower respiratory tract infection (LRTI) in the past four weeks prior to the pre-screening Visit 1, and during pre-screening and run-in periods.
4. Patients with any exacerbation of their underlying asthma during the eight weeks prior to the pre-screening Visit 1.
5. Patients with active allergic rhinitis requiring treatment with systemic corticosteroids.
6. Any of the following criteria are met during the pre-screening/run-in period (Visits 1 - 6):
* in clinic pre-bronchodilator FEV1 % predicted less than 40%,
* more than 12 puffs rescue salbutamol/albuterol HFA MDI per day for \> 2 consecutive days,
* exacerbation of asthma.
7. Patients with a history of pneumonectomy or who are planning to undergo thoracotomy for any reason.
8. Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the six weeks prior to the first screening visit 1.
9. Patients with two or more hospitalizations for asthma within the previous 12 months.
10. Patients with a recent history of myocardial infarction during the last twelve months or known coronary heart disease that requires treatment
11. Patients with a history of hospitalisation due to heart failure in the past twelve months
12. Patients with myocarditis or any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year
13. Patients with significant alcohol or drug abuse in the opinion of the investigator within the past two years
14. Patients with rheumatoid arthritis or other systemic diseases that require immune system modulating treatment
15. Patients suffering from or with a history of glaucoma, increased intraocular pressure, and/or cataracts
16. Pregnant or nursing women
17. Women of childbearing potential not using a highly effective method of birth control.
18. Patients who have been treated with anti-IgE-antibodies (e.g. omalizumab, Xolair®) or other immune system modulating antibodies such as tumor necrosis factor-alpha blockers (TNF-alpha blockers) within six months prior to Visit 1.
19. Patients who have been treated with the following drugs during the past four weeks prior to Visit 1 or are foreseen to need this during the study:
* Non-selective ß-blockers (topical cardio-selective beta-blocker eye medications for non-narrow angle glaucoma are allowed),
* Oral or other systemic corticosteroids,
* Oral beta-agonists,
* Changes in allergen desensitisation therapy in last 6 months,
* Immune system modulating agents such as methotrexate or cyclosporine,
* Inhibitors of cytochrome P450 3A4 such as antifungals (e.g. ketoconazole, itraconazole), antibiotics (e.g. erythromycin) or antiretroviral drugs.
20. Patients who have been treated with leukotriene modifiers, chromones or theophylline within two weeks prior to Visit 1.
21. Patients who have been treated with tiotropium within 3 weeks prior to Visit 1.
12 Years
65 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1248.7.01047 Boehringer Ingelheim Investigational Site
Fountain Valley, California, United States
1248.7.01023 Boehringer Ingelheim Investigational Site
Fullerton, California, United States
1248.7.01038 Boehringer Ingelheim Investigational Site
Long Beach, California, United States
1248.7.01004 Boehringer Ingelheim Investigational Site
Mission Viejo, California, United States
1248.7.01028 Boehringer Ingelheim Investigational Site
Palmdale, California, United States
1248.7.01044 Boehringer Ingelheim Investigational Site
Stockton, California, United States
1248.7.01015 Boehringer Ingelheim Investigational Site
Centennial, Colorado, United States
1248.7.01035 Boehringer Ingelheim Investigational Site
Aventura, Florida, United States
1248.7.01022 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
1248.7.01051 Boehringer Ingelheim Investigational Site
Columbus, Georgia, United States
1248.7.01052 Boehringer Ingelheim Investigational Site
Savannah, Georgia, United States
1248.7.01011 Boehringer Ingelheim Investigational Site
Eagle, Idaho, United States
1248.7.01055 Boehringer Ingelheim Investigational Site
Oak Lawn, Illinois, United States
1248.7.01019 Boehringer Ingelheim Investigational Site
Baltimore, Maryland, United States
1248.7.01039 Boehringer Ingelheim Investigational Site
North Dartmouth, Massachusetts, United States
1248.7.01037 Boehringer Ingelheim Investigational Site
Ypsilanti, Michigan, United States
1248.7.01056 Boehringer Ingelheim Investigational Site
Rolla, Missouri, United States
1248.7.01036 Boehringer Ingelheim Investigational Site
Warrensburg, Missouri, United States
1248.7.01020 Boehringer Ingelheim Investigational Site
Omaha, Nebraska, United States
1248.7.01049 Boehringer Ingelheim Investigational Site
Berlin, New Jersey, United States
1248.7.01026 Boehringer Ingelheim Investigational Site
Ocean City, New Jersey, United States
1248.7.01054 Boehringer Ingelheim Investigational Site
Trenton, New Jersey, United States
1248.7.01031 Boehringer Ingelheim Investigational Site
High Point, North Carolina, United States
1248.7.01045 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
1248.7.01021 Boehringer Ingelheim Investigational Site
Portland, Oregon, United States
1248.7.01013 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
1248.7.01040 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania, United States
1248.7.01012 Boehringer Ingelheim Investigational Site
Upland, Pennsylvania, United States
1248.7.01048 Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
1248.7.01050 Boehringer Ingelheim Investigational Site
Austin, Texas, United States
1248.7.01002 Boehringer Ingelheim Investigational Site
Live Oak, Texas, United States
1248.7.01032 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
1248.7.01046 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
1248.7.01001 Boehringer Ingelheim Investigational Site
Waco, Texas, United States
1248.7.01025 Boehringer Ingelheim Investigational Site
Murray, Utah, United States
1248.7.01053 Boehringer Ingelheim Investigational Site
Alexandria, Virginia, United States
1248.7.01030 Boehringer Ingelheim Investigational Site
Tacoma, Washington, United States
Countries
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Related Links
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Related Info
Other Identifiers
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2010-023169-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1248.7
Identifier Type: -
Identifier Source: org_study_id
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