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

May 27, 2022 updated by: Boehringer Ingelheim

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 22.7, 45.5 and 90.9 Doses b.i.d. Administered Via Respimat® Inhaler and Fluticasone Propionate HFA MDI 88 mcg b.i.d. in Patients With Asthma Inadequately Controlled on SABA Therapy

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fountain Valley, California, United States
        • 1248.5.01047 Boehringer Ingelheim Investigational Site
      • Huntington Beach, California, United States
        • 1248.5.01041 Boehringer Ingelheim Investigational Site
      • Long Beach, California, United States
        • 1248.5.01038 Boehringer Ingelheim Investigational Site
      • Mission Viejo, California, United States
        • 1248.5.01004 Boehringer Ingelheim Investigational Site
      • Palmdale, California, United States
        • 1248.5.01028 Boehringer Ingelheim Investigational Site
      • Rancho Mirage, California, United States
        • 1248.5.01014 Boehringer Ingelheim Investigational Site
      • Stockton, California, United States
        • 1248.5.01044 Boehringer Ingelheim Investigational Site
    • Colorado
      • Centennial, Colorado, United States
        • 1248.5.01015 Boehringer Ingelheim Investigational Site
    • Florida
      • Miami, Florida, United States
        • 1248.5.01022 Boehringer Ingelheim Investigational Site
      • Sarasota, Florida, United States
        • 1248.5.01042 Boehringer Ingelheim Investigational Site
    • Georgia
      • Columbus, Georgia, United States
        • 1248.5.01051 Boehringer Ingelheim Investigational Site
      • Savannah, Georgia, United States
        • 1248.5.01052 Boehringer Ingelheim Investigational Site
    • Idaho
      • Eagle, Idaho, United States
        • 1248.5.01011 Boehringer Ingelheim Investigational Site
    • Illinois
      • Oak Lawn, Illinois, United States
        • 1248.5.01055 Boehringer Ingelheim Investigational Site
    • Maryland
      • Baltimore, Maryland, United States
        • 1248.5.01019 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • North Dartmouth, Massachusetts, United States
        • 1248.5.01039 Boehringer Ingelheim Investigational Site
    • Michigan
      • Ypsilanti, Michigan, United States
        • 1248.5.01037 Boehringer Ingelheim Investigational Site
    • Missouri
      • Rolla, Missouri, United States
        • 1248.5.01056 Boehringer Ingelheim Investigational Site
      • Warrensburg, Missouri, United States
        • 1248.5.01036 Boehringer Ingelheim Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States
        • 1248.5.01020 Boehringer Ingelheim Investigational Site
    • New Jersey
      • Berlin, New Jersey, United States
        • 1248.5.01049 Boehringer Ingelheim Investigational Site
      • Trenton, New Jersey, United States
        • 1248.5.01054 Boehringer Ingelheim Investigational Site
      • Verona, New Jersey, United States
        • 1248.5.01010 Boehringer Ingelheim Investigational Site
    • New York
      • Rochester, New York, United States
        • 1248.5.01006 Boehringer Ingelheim Investigational Site
    • North Carolina
      • High Point, North Carolina, United States
        • 1248.5.01031 Boehringer Ingelheim Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States
        • 1248.5.01045 Boehringer Ingelheim Investigational Site
    • Oregon
      • Gresham, Oregon, United States
        • 1248.5.01005 Boehringer Ingelheim Investigational Site
      • Portland, Oregon, United States
        • 1248.5.01021 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • 1248.5.01013 Boehringer Ingelheim Investigational Site
      • Pittsburgh, Pennsylvania, United States
        • 1248.5.01040 Boehringer Ingelheim Investigational Site
      • Upland, Pennsylvania, United States
        • 1248.5.01012 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States
        • 1248.5.01048 Boehringer Ingelheim Investigational Site
    • Texas
      • Austin, Texas, United States
        • 1248.5.01050 Boehringer Ingelheim Investigational Site
      • Live Oak, Texas, United States
        • 1248.5.01002 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 1248.5.01032 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 1248.5.01046 Boehringer Ingelheim Investigational Site
      • Waco, Texas, United States
        • 1248.5.01001 Boehringer Ingelheim Investigational Site
      • Waco, Texas, United States
        • 1248.5.01007 Boehringer Ingelheim Investigational Site
    • Utah
      • Murray, Utah, United States
        • 1248.5.01025 Boehringer Ingelheim Investigational Site
    • Virginia
      • Alexandria, Virginia, United States
        • 1248.5.01053 Boehringer Ingelheim Investigational Site
    • Washington
      • Tacoma, Washington, United States
        • 1248.5.01030 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: BI 54903
BI 54903
Experimental: 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.
Drug: BI 54903
BI 54903
Experimental: 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.
Drug: BI 54903
BI 54903
Active Comparator: 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.
Drug: Fluticasone propionate
Fluticasone propionate
Placebo Comparator: Placebo
Placebo Respimat inhaler 2 puffs b.i.d. and placebo HFA MDI, 2 puffs b.i.d.
Drug: Placebo
Placebo matching fluticasone propionate HFA MDI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Time Frame: At baseline and week 8.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: At baseline and at week 2 and 4.
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 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
Time Frame: 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.
Mean Change From Randomisation Baseline in Asthma Control Questionnaire (ACQ-6) Scores at Subsequent Study Visits
Time Frame: At baseline and at week 2, 4 and 8.
The Asthma Control Questionnaire (ACQ) consists of 6 patient self-evaluated questions with each question in 7-point scale. The items are equally weighted and the ACQ score is the mean of 6 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of less than or equal to 0.75 indicate well-controlled asthma, scores between 0.76 and less than 1.5 indicate partly controlled asthma, and a score greater than or equal to 1.5 indicates uncontrolled asthma.
At baseline and at week 2, 4 and 8.
Mean Change From Randomisation Baseline in Asthma Quality of Life Questionnaire (AQLQ(S)+12) Scores at Subsequent Study Visits
Time Frame: At baseline and at week 2, 4 and 8.
AQLQ(S)+12 are well established and validated questionnaires to measure control of asthma symptoms and quality of life, which is a patient-reported self-administered outcome questionnaire containing 32 items. Each item is scored on a 7-point scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life.
At baseline and at week 2, 4 and 8.
Time to Withdrawal Due to First Asthma Exacerbation
Time Frame: At week 8.
Time to withdrawal due to first asthma exacerbation.
At week 8.
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
Time Frame: At baseline and week 2, 4, 8.
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
Time Frame: At baseline and at week 2, 4 and 8.
Mean change from randomization baseline in through (morning pre-dose and pre-rescue bronchodilator) Forced expiratory flow between 25% and 75% of vital capacity (FEF 25-75) 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
Time Frame: At week 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 21, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 23, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1248.5
  • 2010-023167-17 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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