Dose Finding Study on BI54903 (Inhaled Corticosteroid) Administered Twice Daily Via Respimat® Inhaler in Asthmatic Patients Inadequately Controlled on Short-acting-beta-agonist (SABA) Therapy

NCT ID: NCT01397162

Last Updated: 2022-06-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-21
• Study Completion Date: 2011-12-23

Brief Summary

The aim of the study is to assess and compare efficacy and safety of BI 54903 at 3 doses twice daily (b.i.d.) and fluticasone propionate hydrofluoroalkane metered dose inhaler (HFA MDI) at a dose of 88 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 short-acting-beta-agonist (SABA) prn therapy only as demonstrated by a decrease in forced expiratory volume in one second (FEV1) range10 to 25% and an asthma control questionnaire (ACQ-6) equal or greater than 1.5 at time of randomization

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BI 54903 - low dose

BI 54903 low dose 2 puffs twice daily (b.i.d.) via Respimat inhaler plus hydrofluoralkane (HFA) metered dose inhaler (MDI) matching placebo 2 puffs b.i.d.

Group Type: EXPERIMENTAL

BI 54903

Intervention Type: DRUG

BI 54903

BI 54903 - medium dose

BI 54903 medium dose 2 puffs b.i.d. via Respimat inhaler plus HFA MDI matching placebo 2 puffs b.i.d.

Group Type: EXPERIMENTAL

BI 54903

Intervention Type: DRUG

BI 54903

BI 54903 - high dose

BI 54903 high dose 2 puffs b.i.d. via Respimat inhaler plus HFA MDI matching placebo 2 puffs b.i.d.

Group Type: EXPERIMENTAL

BI 54903

Intervention Type: DRUG

BI 54903

Fluticasone propionate

Fluticasone propionate 2 puffs twice b.i.d via HFA MDI plus placebo BI 54903 via Respimat inhaler 2 puffs b.i.d.

Group Type: ACTIVE_COMPARATOR

Fluticasone propionate

Intervention Type: DRUG

Fluticasone propionate

Placebo

Placebo Respimat inhaler 2 puffs b.i.d. and placebo HFA MDI, 2 puffs b.i.d.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo matching fluticasone propionate HFA MDI

Interventions

Fluticasone propionate

Fluticasone propionate

Intervention Type: DRUG

Placebo

Placebo matching fluticasone propionate HFA MDI

Intervention Type: DRUG

BI 54903

BI 54903

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male and female patients aged at least 12 to 65 years

2. 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 low-dose inhaled corticosteroid (ICS) plus long-acting-beta -agonist (LABA) or medium-dose ICS without 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 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 forced expiratory volume in one second (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 9 Patients must be able to use Respimat® inhaler and metered dose inhaler (MDI) correctly 10 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

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 (URTI/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 forced expiratory volume in one second (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 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1248.5.01047 Boehringer Ingelheim Investigational Site

Fountain Valley, California, United States

1248.5.01041 Boehringer Ingelheim Investigational Site

Huntington Beach, California, United States

1248.5.01038 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

1248.5.01004 Boehringer Ingelheim Investigational Site

Mission Viejo, California, United States

1248.5.01028 Boehringer Ingelheim Investigational Site

Palmdale, California, United States

1248.5.01014 Boehringer Ingelheim Investigational Site

Rancho Mirage, California, United States

1248.5.01044 Boehringer Ingelheim Investigational Site

Stockton, California, United States

1248.5.01015 Boehringer Ingelheim Investigational Site

Centennial, Colorado, United States

1248.5.01022 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

1248.5.01042 Boehringer Ingelheim Investigational Site

Sarasota, Florida, United States

1248.5.01051 Boehringer Ingelheim Investigational Site

Columbus, Georgia, United States

1248.5.01052 Boehringer Ingelheim Investigational Site

Savannah, Georgia, United States

1248.5.01011 Boehringer Ingelheim Investigational Site

Eagle, Idaho, United States

1248.5.01055 Boehringer Ingelheim Investigational Site

Oak Lawn, Illinois, United States

1248.5.01019 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

1248.5.01039 Boehringer Ingelheim Investigational Site

North Dartmouth, Massachusetts, United States

1248.5.01037 Boehringer Ingelheim Investigational Site

Ypsilanti, Michigan, United States

1248.5.01056 Boehringer Ingelheim Investigational Site

Rolla, Missouri, United States

1248.5.01036 Boehringer Ingelheim Investigational Site

Warrensburg, Missouri, United States

1248.5.01020 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

1248.5.01049 Boehringer Ingelheim Investigational Site

Berlin, New Jersey, United States

1248.5.01054 Boehringer Ingelheim Investigational Site

Trenton, New Jersey, United States

1248.5.01010 Boehringer Ingelheim Investigational Site

Verona, New Jersey, United States

1248.5.01006 Boehringer Ingelheim Investigational Site

Rochester, New York, United States

1248.5.01031 Boehringer Ingelheim Investigational Site

High Point, North Carolina, United States

1248.5.01045 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

1248.5.01005 Boehringer Ingelheim Investigational Site

Gresham, Oregon, United States

1248.5.01021 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

1248.5.01013 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

1248.5.01040 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

1248.5.01012 Boehringer Ingelheim Investigational Site

Upland, Pennsylvania, United States

1248.5.01048 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

1248.5.01050 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

1248.5.01002 Boehringer Ingelheim Investigational Site

Live Oak, Texas, United States

1248.5.01032 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

1248.5.01046 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

1248.5.01001 Boehringer Ingelheim Investigational Site

Waco, Texas, United States

1248.5.01007 Boehringer Ingelheim Investigational Site

Waco, Texas, United States

1248.5.01025 Boehringer Ingelheim Investigational Site

Murray, Utah, United States

1248.5.01053 Boehringer Ingelheim Investigational Site

Alexandria, Virginia, United States

1248.5.01030 Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

Countries

United States

Related Links

http://www.mystudywindow.com/

Related Info

Other Identifiers

2010-023167-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1248.5

Identifier Type: -

Identifier Source: org_study_id