Study on BI 54903 (Inhaled Corticosteroid) Administered Twice Daily Via Respimat Inhaler in Patients With Asthma Inadequately Controlled on Medium Dose Inhaled Corticosteroid (ICS).

NCT01396278 | Terminated Phase 2 Results

• 2 other identifiers: 1248.72010-023169-23
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 37

Brief Summary

The aim of the study is to assess and compare efficacy and safety of BI 54903 at three different dosages (b.i.d)., fluticasone propionate hydrofluoroalkane (HFA) metered dose inhaler (MDI) at a dose of 440 mcg b.i.d and low dose fluticasone propionate 88 mcg b.i.d. over an 8-week treatment period in asthmatic patients aged 12 to 65 years inadequately controlled medium dose ICS therapy as demonstrated by a decrease in forced expiratory volume in one second (FEV1) range 10 to 25 % and an asthma control questionnaire-6 (ACQ-6) equal or greater than 1.5 at time of randomisation.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Mean Change From 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 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 Randomization Baseline in Trough (Morning 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 Randomization Baseline in Trough (Morning Pre-dose and Pre-rescue Bronchodilator) FEV1 After 2 and 4-week Treatment Periods

  At baseline and week 2 and 4.

• Mean Pre-dose (and Pre-rescue) Peak Expiratory Flow (PEF) as Assessed Via Asthma Monitor2+ (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 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 ACQ-6 Scores at Subsequent Study Visits

  At baseline and week 2, 4, 8.

Study Arms (5)

BI 54903 low dose

EXPERIMENTAL

patient to receive Respimat inhaler containing low dose BI 54903 plus placebo matching hydrofluoroalkane (HFA) metered dose inhaler (MDI)

Drug: Placebo; Drug: BI 54903

BI 54903 medium dose

EXPERIMENTAL

Respimat inhaler containing medium dose BI 54903 plus placebo matching HFA MDI

Drug: Placebo; Drug: BI 54903

BI 54903 high dose

EXPERIMENTAL

Respimat inhaler containing high dose BI 54903 plus placebo matching HFA MDI

Drug: Placebo; Drug: BI 54903

Fluticasone propionate 440 mcg BID

ACTIVE COMPARATOR

Fluticasone HFA MDI containing 440 mcg ICS plus placebo matching Respimat inhaler

Drug: Fluticasone propionate

Fluticasone propionate 88 mcg BID

ACTIVE COMPARATOR

Fluticasone HFA MDI containing 88 mcg ICS plus placebo matching Respimat inhaler

Drug: Fluticasone propionate

Interventions

Placebo DRUG

Placebo matching fluticasone propionate HFA MDI

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

Fluticasone propionate DRUG

Fluticasone propionate HFA MDI

Fluticasone propionate 440 mcg BID; Fluticasone propionate 88 mcg BID

BI 54903 DRUG

BI 54903 via Respimat inhaler

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:

• Must be willing and able to give informed consent.
• 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.
• 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
• 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.
• 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 .
• Patients must be able to use Respimat® inhaler and MDI correctly
• 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:
• 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.
• 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.

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) that may, in the opinion of the investigator, result in any of the following: (i) put the patient at risk because of participation in this trial or (ii) influence the results of the trial or (iii) cause concern regarding the patient´s ability to participate in the trial.
• 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.
• 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 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (37)

1248.7.01047 Boehringer Ingelheim Investigational Site

Fountain Valley, California, United States

Location

1248.7.01023 Boehringer Ingelheim Investigational Site

Fullerton, California, United States

Location

1248.7.01038 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

Location

1248.7.01004 Boehringer Ingelheim Investigational Site

Mission Viejo, California, United States

Location

1248.7.01028 Boehringer Ingelheim Investigational Site

Palmdale, California, United States

Location

1248.7.01044 Boehringer Ingelheim Investigational Site

Stockton, California, United States

Location

1248.7.01015 Boehringer Ingelheim Investigational Site

Centennial, Colorado, United States

Location

1248.7.01035 Boehringer Ingelheim Investigational Site

Aventura, Florida, United States

Location

1248.7.01022 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1248.7.01051 Boehringer Ingelheim Investigational Site

Columbus, Georgia, United States

Location

1248.7.01052 Boehringer Ingelheim Investigational Site

Savannah, Georgia, United States

Location

1248.7.01011 Boehringer Ingelheim Investigational Site

Eagle, Idaho, United States

Location

1248.7.01055 Boehringer Ingelheim Investigational Site

Oak Lawn, Illinois, United States

Location

1248.7.01019 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Location

1248.7.01039 Boehringer Ingelheim Investigational Site

North Dartmouth, Massachusetts, United States

Location

1248.7.01037 Boehringer Ingelheim Investigational Site

Ypsilanti, Michigan, United States

Location

1248.7.01056 Boehringer Ingelheim Investigational Site

Rolla, Missouri, United States

Location

1248.7.01036 Boehringer Ingelheim Investigational Site

Warrensburg, Missouri, United States

Location

1248.7.01020 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

Location

1248.7.01049 Boehringer Ingelheim Investigational Site

Berlin, New Jersey, United States

Location

1248.7.01026 Boehringer Ingelheim Investigational Site

Ocean City, New Jersey, United States

Location

1248.7.01054 Boehringer Ingelheim Investigational Site

Trenton, New Jersey, United States

Location

1248.7.01031 Boehringer Ingelheim Investigational Site

High Point, North Carolina, United States

Location

1248.7.01045 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

1248.7.01021 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

Location

1248.7.01013 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

1248.7.01040 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

Location

1248.7.01012 Boehringer Ingelheim Investigational Site

Upland, Pennsylvania, United States

Location

1248.7.01048 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Location

1248.7.01050 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Location

1248.7.01002 Boehringer Ingelheim Investigational Site

Live Oak, Texas, United States

Location

1248.7.01032 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1248.7.01046 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1248.7.01001 Boehringer Ingelheim Investigational Site

Waco, Texas, United States

Location

1248.7.01025 Boehringer Ingelheim Investigational Site

Murray, Utah, United States

Location

1248.7.01053 Boehringer Ingelheim Investigational Site

Alexandria, Virginia, United States

Location

1248.7.01030 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 sponsor. As limited data were collected due to early termination and only limited number of patients completing 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 15, 2011
• First Posted: July 18, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 14, 2011
• Last Updated: February 7, 2025
• Results First Posted: June 23, 2022

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (37)