A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess and Compare Efficacy and Safety of an 8-week Treatment With BI 54903 at Doses of 45.5, 90.9 and 181.8 mcg b.i.d. Administered Via Respimat® Inhaler and Fluticasone Propionate HFA 220 mcg b.i.d. in Patients With Asthma Inadequately Controlled on Low Dose ICS Therapy
- NCT01397201
- PHASE2
- INTERVENTIONAL
Last updated: 2022-06-23
Purpose of Trial
The aim of the study is to assess and compare efficacy and safety of BI 54903 at 3 doses twice daily (b.i.d.), fluticasone propionate hydrofluoroalkane metered dose inhaler (HFA MDI) at a dose of 220 mcg b.i.d. and placebo b.i.d. over an 8-week treatment period in asthmatic patients aged 12 to 65 years inadequately controlled on low dose Inhaled corticosteroid (ICS) as demonstrated by a decrease in forced expiratory volume in one second (FEV1 (range 10-25%) and an asthma control questionnaire (ACQ-6) greater or equal 1.5 at time of randomisation
This study is for people with
Asthma
Interventions being studied
Placebo
BI 54903
Fluticasone propionate
Inclusion criteria:
1. Must be willing and able to give informed consent
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 either medium-dose inhaled corticosteroid (ICS) plus long acting beta agonist (LABA) or high-dose inhaled corticosteroid (ICS) without long acting beta agonist (LABA), stable for at least six weeks prior to Visit 1
5. All patients must have a pre-bronchodilator forced expiratory volume in one second (FEV1) of not less than 60 to 90% of predicted normal and an asthma control questionnaire (ACQ-6) mean score of less than 1.5 at the pre-screening Visit 1
6. 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 hydrofluoroalkane metered dose inhaler (HFA MDI)
7. 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
8. Patients must be able to use Respimat® inhaler and metered dose inhaler (MDI) correctly
9. 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
10. To enter treatment period following additional criteria have to be met (at randomisation visit):
* 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:
1. Patients with significant pulmonary disease other than asthma or other significant medical conditions (as determined by medical history, examination and clinical investigations at screening)
2. Patients with a clinically relevant, abnormal screening haematology and/or blood chemistry finding
3. Patients with a history of upper or lower respiratory tract infection 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 forced expiratory volume in one second (FEV1 %) predicted less than 40%,
* more than 12 puffs rescue salbutamol/albuterol hydrofluoroalkane metered dose inhaler (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 twelve 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 narrow angle glaucoma 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-Immunoglobin-E-antibodies (e.g. omalizumab, Xolair®) or other immune system modulating antibodies such as tumor necrosis factor-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 beta-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.
* Patients who have been treated with leukotriene modifiers, chromones or theophylline within two weeks prior to Visit 1
* Patients who have been treated with tiotropium within 3 weeks prior to Visit 1
ELIGIBILITY
Gender: ALL
Age: 12+
Healthy Volunteers: No
41 Locations
Fountain Valley
1248.6.01047 Boehringer Ingelheim Investigational Site
California, United States
Fullerton
1248.6.01023 Boehringer Ingelheim Investigational Site
California, United States
Huntington Beach
1248.6.01041 Boehringer Ingelheim Investigational Site
California, United States
Long Beach
1248.6.01038 Boehringer Ingelheim Investigational Site
California, United States
Mission Viejo
1248.6.01004 Boehringer Ingelheim Investigational Site
California, United States
Palmdale
1248.6.01028 Boehringer Ingelheim Investigational Site
California, United States
Stockton
1248.6.01044 Boehringer Ingelheim Investigational Site
California, United States
Walnut Creek
1248.6.01034 Boehringer Ingelheim Investigational Site
California, United States
Centennial
1248.6.01015 Boehringer Ingelheim Investigational Site
Colorado, United States
Aventura
1248.6.01035 Boehringer Ingelheim Investigational Site
Florida, United States
Miami
1248.6.01022 Boehringer Ingelheim Investigational Site
Florida, United States
Sarasota
1248.6.01042 Boehringer Ingelheim Investigational Site
Florida, United States
Columbus
1248.6.01051 Boehringer Ingelheim Investigational Site
Georgia, United States
Savannah
1248.6.01052 Boehringer Ingelheim Investigational Site
Georgia, United States
Eagle
1248.6.01011 Boehringer Ingelheim Investigational Site
Idaho, United States
Oak Lawn
1248.6.01055 Boehringer Ingelheim Investigational Site
Illinois, United States
Baltimore
1248.6.01019 Boehringer Ingelheim Investigational Site
Maryland, United States
North Dartmouth
1248.6.01039 Boehringer Ingelheim Investigational Site
Massachusetts, United States
Ypsilanti
1248.6.01037 Boehringer Ingelheim Investigational Site
Michigan, United States
Rolla
1248.6.01056 Boehringer Ingelheim Investigational Site
Missouri, United States
Warrensburg
1248.6.01036 Boehringer Ingelheim Investigational Site
Missouri, United States
Omaha
1248.6.01020 Boehringer Ingelheim Investigational Site
Nebraska, United States
Berlin
1248.6.01049 Boehringer Ingelheim Investigational Site
New Jersey, United States
Trenton
1248.6.01054 Boehringer Ingelheim Investigational Site
New Jersey, United States
Verona
1248.6.01010 Boehringer Ingelheim Investigational Site
New Jersey, United States
Rochester
1248.6.01006 Boehringer Ingelheim Investigational Site
New York, United States
High Point
1248.6.01031 Boehringer Ingelheim Investigational Site
North Carolina, United States
Cincinnati
1248.6.01045 Boehringer Ingelheim Investigational Site
Ohio, United States
Gresham
1248.6.01005 Boehringer Ingelheim Investigational Site
Oregon, United States
Portland
1248.6.01021 Boehringer Ingelheim Investigational Site
Oregon, United States
Philadelphia
1248.6.01013 Boehringer Ingelheim Investigational Site
Pennsylvania, United States
Pittsburgh
1248.6.01040 Boehringer Ingelheim Investigational Site
Pennsylvania, United States
Upland
1248.6.01012 Boehringer Ingelheim Investigational Site
Pennsylvania, United States
Charleston
1248.6.01048 Boehringer Ingelheim Investigational Site
South Carolina, United States
Austin
1248.6.01050 Boehringer Ingelheim Investigational Site
Texas, United States
Live Oak
1248.6.01002 Boehringer Ingelheim Investigational Site
Texas, United States
San Antonio
1248.6.01046 Boehringer Ingelheim Investigational Site
Texas, United States
Waco
1248.6.01001 Boehringer Ingelheim Investigational Site
Texas, United States
Murray
1248.6.01025 Boehringer Ingelheim Investigational Site
Utah, United States
Alexandria
1248.6.01053 Boehringer Ingelheim Investigational Site
Virginia, United States
Tacoma
1248.6.01030 Boehringer Ingelheim Investigational Site
Washington, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov