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

NCT01397162 | Terminated Phase 2 Results

• 2 other identifiers: 1248.52010-023167-17
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 41

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

Outcome Measures

Primary Outcomes (1)

• Mean Change From the Randomisation Baseline to the End of the 8-week Treatment Period in Trough (Morning Pre-dose and Pre-rescue Bronchodilator ) Forced Expiratory Volume in One Second (FEV1)

  Mean change from the randomisation baseline to the end of the 8-week treatment period in trough (morning pre-dose and pre-rescue bronchodilator ) forced expiratory volume in one second (FEV1).

  At baseline and week 8.

Secondary Outcomes (8)

• Mean Changes From Randomisation Baseline in Trough (Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in One Second (FEV1) After 2 and 4-week Treatment Periods

  At baseline and at week 2 and 4.

• Mean Changes From Randomisation Baseline in Trough (Pre-dose and Pre-rescue Bronchodilator) Forced Vital Capacity (FVC) After 2, 4 and 8-week Treatment Periods

  At baseline and week 2, 4, 8.

• Mean Changes From Randomisation Baseline in Trough (Morning Pre-dose and Prerescue Bronchodilator) FEF25-75 After 2, 4 and 8-week Treatment Periods

  At baseline and at week 2, 4 and 8.

• Mean Pre-dose (and Pre-rescue) Peak Expiratory Flow (PEF) as Assessed Via Asthma Monitor (AM2+) in the Morning and Evening, of the Last Week of the 8-week Treatment Period

  At week 8.

• Mean Rescue Medication Use (Daytime and Night-time) as Assessed Via Asthma Monitor (AM2+) in the Morning and Evening, of the Last Week of the 8-week Treatment Period

  At week 8.

Study Arms (5)

BI 54903 - low dose

EXPERIMENTAL

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.

Drug: BI 54903

BI 54903 - medium dose

EXPERIMENTAL

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

Drug: BI 54903

BI 54903 - high dose

EXPERIMENTAL

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

Drug: BI 54903

Fluticasone propionate

ACTIVE COMPARATOR

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

Drug: Fluticasone propionate

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Fluticasone propionate DRUG

Fluticasone propionate

Fluticasone propionate

Placebo DRUG

Placebo matching fluticasone propionate HFA MDI

Placebo

BI 54903 DRUG

BI 54903

BI 54903 - high dose; BI 54903 - low dose; BI 54903 - medium dose

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients aged at least 12 to 65 years
• 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
• 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

You may not qualify if:

• Patients with significant pulmonary disease other than asthma or other significant medical conditions (as determined by medical history, examination and clinical investigations at screening)
• Patients with a clinically relevant, abnormal screening haematology and/or blood chemistry finding
• 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
• Patients with any exacerbation of their underlying asthma during the eight weeks prior to the pre-screening Visit 1
• Patients with active allergic rhinitis requiring treatment with systemic corticosteroids
• 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
• Patients with a history of pneumonectomy or who are planning to undergo thoracotomy for any reason
• 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
• Patients with two or more hospitalizations for asthma within the previous 12 months
• Patients with a recent history of myocardial infarction during the last twelve months or known coronary heart disease that requires treatment
• Patients with a history of hospitalisation due to heart failure in the past twelve months
• 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
• Patients with significant alcohol or drug abuse in the opinion of the investigator within the past two years
• Patients with rheumatoid arthritis or other systemic diseases that require immune system modulating treatment
• Patients suffering from narrow angle glaucoma with a history of glaucoma, increased intraocular pressure, and/or cataracts

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (41)

1248.5.01047 Boehringer Ingelheim Investigational Site

Fountain Valley, California, United States

Location

1248.5.01041 Boehringer Ingelheim Investigational Site

Huntington Beach, California, United States

Location

1248.5.01038 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

Location

1248.5.01004 Boehringer Ingelheim Investigational Site

Mission Viejo, California, United States

Location

1248.5.01028 Boehringer Ingelheim Investigational Site

Palmdale, California, United States

Location

1248.5.01014 Boehringer Ingelheim Investigational Site

Rancho Mirage, California, United States

Location

1248.5.01044 Boehringer Ingelheim Investigational Site

Stockton, California, United States

Location

1248.5.01015 Boehringer Ingelheim Investigational Site

Centennial, Colorado, United States

Location

1248.5.01022 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1248.5.01042 Boehringer Ingelheim Investigational Site

Sarasota, Florida, United States

Location

1248.5.01051 Boehringer Ingelheim Investigational Site

Columbus, Georgia, United States

Location

1248.5.01052 Boehringer Ingelheim Investigational Site

Savannah, Georgia, United States

Location

1248.5.01011 Boehringer Ingelheim Investigational Site

Eagle, Idaho, United States

Location

1248.5.01055 Boehringer Ingelheim Investigational Site

Oak Lawn, Illinois, United States

Location

1248.5.01019 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Location

1248.5.01039 Boehringer Ingelheim Investigational Site

North Dartmouth, Massachusetts, United States

Location

1248.5.01037 Boehringer Ingelheim Investigational Site

Ypsilanti, Michigan, United States

Location

1248.5.01056 Boehringer Ingelheim Investigational Site

Rolla, Missouri, United States

Location

1248.5.01036 Boehringer Ingelheim Investigational Site

Warrensburg, Missouri, United States

Location

1248.5.01020 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

Location

1248.5.01049 Boehringer Ingelheim Investigational Site

Berlin, New Jersey, United States

Location

1248.5.01054 Boehringer Ingelheim Investigational Site

Trenton, New Jersey, United States

Location

1248.5.01010 Boehringer Ingelheim Investigational Site

Verona, New Jersey, United States

Location

1248.5.01006 Boehringer Ingelheim Investigational Site

Rochester, New York, United States

Location

1248.5.01031 Boehringer Ingelheim Investigational Site

High Point, North Carolina, United States

Location

1248.5.01045 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

1248.5.01005 Boehringer Ingelheim Investigational Site

Gresham, Oregon, United States

Location

1248.5.01021 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

Location

1248.5.01013 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

1248.5.01040 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

Location

1248.5.01012 Boehringer Ingelheim Investigational Site

Upland, Pennsylvania, United States

Location

1248.5.01048 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Location

1248.5.01050 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Location

1248.5.01002 Boehringer Ingelheim Investigational Site

Live Oak, Texas, United States

Location

1248.5.01032 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1248.5.01046 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1248.5.01001 Boehringer Ingelheim Investigational Site

Waco, Texas, United States

Location

1248.5.01007 Boehringer Ingelheim Investigational Site

Waco, Texas, United States

Location

1248.5.01025 Boehringer Ingelheim Investigational Site

Murray, Utah, United States

Location

1248.5.01053 Boehringer Ingelheim Investigational Site

Alexandria, Virginia, United States

Location

1248.5.01030 Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

Study was terminated by the decision of the sponsor. As limited data were collected due to early termination and only limited number of patients completed the 8-week treatment period, no analyses of primary and secondary endpoints were conducted.

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2011
• First Posted: July 19, 2011
• Study Start: July 21, 2011
• Primary Completion: December 23, 2011
• Study Completion: December 23, 2011
• Last Updated: June 23, 2022
• Results First Posted: June 23, 2022

Record last verified: 2022-05

Locations

US (41)