BI 671800 ED in Steroid-naive Asthmatic Patients

May 27, 2022 updated by: Boehringer Ingelheim

A Randomized, Double Blind, Placebo and Active Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of 6-week Treatment With Oral Doses of 50 mg b.i.d., 200 mg b.i.d., and 400 mg b.i.d. BI 671800 ED in Steroid-naïve Patients With Persistent Asthma

This is a 6 week study to investigate the effectiveness and safety of BI 671800 ED in patients with asthma who do not take inhaled corticosteroids.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

389

Phase

  • 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

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia
        • 1268.17.61001 Boehringer Ingelheim Investigational Site
  • Canada
      • Quebec, Canada
        • 1268.17.02001 Boehringer Ingelheim Investigational Site
      • Quebec, Canada
        • 1268.17.02004 Boehringer Ingelheim Investigational Site
    • Ontario
      • Hawkesbury, Ontario, Canada
        • 1268.17.02012 Boehringer Ingelheim Investigational Site
      • Mississauga, Ontario, Canada
        • 1268.17.02010 Boehringer Ingelheim Investigational Site
      • Newmarket, Ontario, Canada
        • 1268.17.02014 Boehringer Ingelheim Investigational Site
      • Sudbury, Ontario, Canada
        • 1268.17.02015 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada
        • 1268.17.02003 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada
        • 1268.17.02013 Boehringer Ingelheim Investigational Site
  • Colombia
      • Bogotá, Colombia
        • 1268.17.57003 Boehringer Ingelheim Investigational Site
      • Bogotá, Colombia
        • 1268.17.57004 Boehringer Ingelheim Investigational Site
      • Medellín, Colombia
        • 1268.17.57002 Boehringer Ingelheim Investigational Site
  • Korea, Republic of
      • Cheongju, Korea, Republic of
        • 1268.17.82007 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1268.17.82001 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1268.17.82002 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1268.17.82004 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1268.17.82005 Boehringer Ingelheim Investigational Site
      • Seoul, Korea, Republic of
        • 1268.17.82006 Boehringer Ingelheim Investigational Site
      • Suwon, Korea, Republic of
        • 1268.17.82003 Boehringer Ingelheim Investigational Site
      • Wonju, Korea, Republic of
        • 1268.17.82008 Boehringer Ingelheim Investigational Site
  • Mexico
      • Cuernavaca, Mexico
        • 1268.17.52002 Boehringer Ingelheim Investigational Site
      • Monterrey, Mexico
        • 1268.17.52001 Boehringer Ingelheim Investigational Site
      • Toriello Guerra, Mexico
        • 1268.17.52004 Boehringer Ingelheim Investigational Site
      • Zona Río, Mexico
        • 1268.17.52003 Boehringer Ingelheim Investigational Site
  • New Zealand
      • Christchurch, New Zealand
        • 1268.17.64001 Boehringer Ingelheim Investigational Site
      • Greenlane East Auckland, New Zealand
        • 1268.17.64003 Boehringer Ingelheim Investigational Site
      • Newtown Wellington NZ, New Zealand
        • 1268.17.64002 Boehringer Ingelheim Investigational Site
  • Peru
      • Jesús María, Peru
        • 1268.17.51003 Boehringer Ingelheim Investigational Site
      • Lima, Peru
        • 1268.17.51002 Boehringer Ingelheim Investigational Site
      • San Borja, Peru
        • 1268.17.51006 Boehringer Ingelheim Investigational Site
      • San Isidro., Peru
        • 1268.17.51004 Boehringer Ingelheim Investigational Site
      • Santiago de Surco, Peru
        • 1268.17.51005 Boehringer Ingelheim Investigational Site
      • Urb. Ingeniería, Peru
        • 1268.17.51001 Boehringer Ingelheim Investigational Site
  • Philippines
      • Caloocan City, Philippines
        • 1268.17.63007 Boehringer Ingelheim Investigational Site
      • Manila, Philippines
        • 1268.17.63002 Boehringer Ingelheim Investigational Site
      • Quezon City, Philippines
        • 1268.17.63001 Boehringer Ingelheim Investigational Site
      • Quezon City, Philippines
        • 1268.17.63003 Boehringer Ingelheim Investigational Site
      • Quezon City, Philippines
        • 1268.17.63004 Boehringer Ingelheim Investigational Site
      • Quezon City, Philippines
        • 1268.17.63005 Boehringer Ingelheim Investigational Site
      • Quezon City, Philippines
        • 1268.17.63006 Boehringer Ingelheim Investigational Site
  • Taiwan
      • Chiayi City, Taiwan
        • 1268.17.86210 Boehringer Ingelheim Investigational Site
      • Kaohsiung City, Taiwan
        • 1268.17.86211 Boehringer Ingelheim Investigational Site
      • Taichung, Taiwan
        • 1268.17.86207 Boehringer Ingelheim Investigational Site
      • Taichung, Taiwan
        • 1268.17.86208 Boehringer Ingelheim Investigational Site
      • Taichung, Taiwan
        • 1268.17.86209 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan
        • 1268.17.86201 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan
        • 1268.17.86202 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan
        • 1268.17.86203 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan
        • 1268.17.86204 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan
        • 1268.17.86205 Boehringer Ingelheim Investigational Site
      • Taipei, Taiwan
        • 1268.17.86206 Boehringer Ingelheim Investigational Site
      • Taoyuan County, Taiwan
        • 1268.17.86200 Boehringer Ingelheim Investigational Site
  • United States
    • Arizona
      • Tucson, Arizona, United States
        • 1268.17.01043 Boehringer Ingelheim Investigational Site
    • California
      • Cypress, California, United States
        • 1268.17.01009 Boehringer Ingelheim Investigational Site
      • Los Angeles, California, United States
        • 1268.17.01006 Boehringer Ingelheim Investigational Site
      • Palmdale, California, United States
        • 1268.17.01040 Boehringer Ingelheim Investigational Site
      • San Jose, California, United States
        • 1268.17.01024 Boehringer Ingelheim Investigational Site
      • Stockton, California, United States
        • 1268.17.01003 Boehringer Ingelheim Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States
        • 1268.17.01015 Boehringer Ingelheim Investigational Site
      • Denver, Colorado, United States
        • 1268.17.01001 Boehringer Ingelheim Investigational Site
      • Lakewood, Colorado, United States
        • 1268.17.01016 Boehringer Ingelheim Investigational Site
      • Wheat Ridge, Colorado, United States
        • 1268.17.01033 Boehringer Ingelheim Investigational Site
    • Florida
      • DeLand, Florida, United States
        • 1268.17.01045 Boehringer Ingelheim Investigational Site
    • Illinois
      • Normal, Illinois, United States
        • 1268.17.01036 Boehringer Ingelheim Investigational Site
    • Indiana
      • South Bend, Indiana, United States
        • 1268.17.01025 Boehringer Ingelheim Investigational Site
    • Iowa
      • Iowa City, Iowa, United States
        • 1268.17.01005 Boehringer Ingelheim Investigational Site
    • Maryland
      • Baltimore, Maryland, United States
        • 1268.17.01034 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • North Dartmouth, Massachusetts, United States
        • 1268.17.01014 Boehringer Ingelheim Investigational Site
      • North Dartmouth, Massachusetts, United States
        • 1268.17.01030 Boehringer Ingelheim Investigational Site
    • Michigan
      • Novi, Michigan, United States
        • 1268.17.01027 Boehringer Ingelheim Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States
        • 1268.17.01032 Boehringer Ingelheim Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States
        • 1268.17.01010 Boehringer Ingelheim Investigational Site
      • Saint Louis, Missouri, United States
        • 1268.17.01037 Boehringer Ingelheim Investigational Site
    • Montana
      • Bozeman, Montana, United States
        • 1268.17.01022 Boehringer Ingelheim Investigational Site
    • Nebraska
      • Bellevue, Nebraska, United States
        • 1268.17.01008 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Raleigh, North Carolina, United States
        • 1268.17.01011 Boehringer Ingelheim Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States
        • 1268.17.01004 Boehringer Ingelheim Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • 1268.17.01038 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • 1268.17.01042 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States
        • 1268.17.01007 Boehringer Ingelheim Investigational Site
      • Easley, South Carolina, United States
        • 1268.17.01031 Boehringer Ingelheim Investigational Site
      • Fort Mill, South Carolina, United States
        • 1268.17.01039 Boehringer Ingelheim Investigational Site
      • Greenville, South Carolina, United States
        • 1268.17.01026 Boehringer Ingelheim Investigational Site
      • Greenville, South Carolina, United States
        • 1268.17.01029 Boehringer Ingelheim Investigational Site
      • Spartanburg, South Carolina, United States
        • 1268.17.01049 Boehringer Ingelheim Investigational Site
    • Texas
      • Dallas, Texas, United States
        • 1268.17.01019 Boehringer Ingelheim Investigational Site
      • El Paso, Texas, United States
        • 1268.17.01012 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 1268.17.01023 Boehringer Ingelheim Investigational Site
      • Killeen, Texas, United States
        • 1268.17.01048 Boehringer Ingelheim Investigational Site
      • New Braunfels, Texas, United States
        • 1268.17.01028 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 1268.17.01035 Boehringer Ingelheim Investigational Site
    • Washington
      • Tacoma, Washington, United States
        • 1268.17.01047 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

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Signed informed consent consistent with ICH-GCP
  2. Three month history of reversible (12% with 200 mL) asthma (according to GINA) with following spirometry at randomization: FEV1 60%-85%.
  3. No ICS previous 3 months prior to screening.
  4. Diagnosis of asthma prior to 40 years.
  5. ACQ at least 1.5 at randomization.
  6. Male or female, 18 to 65 years.
  7. Non-smokers or ex-smokers ( less than 10 pack year history) with negative cotinine screen.
  8. Able to perform PFT

Exclusion criteria:

  1. Significant diseases other than asthma or allergic rhinitis.
  2. Hepatic transaminases or total bilirubin greater than 1.5 ULN.
  3. Hospitalizations for asthma or asthma related intubation within 3 months.
  4. Uncontrolled asthma.
  5. Respiratory tract infection or exacerbation within 4 weeks.
  6. FEV1 less than 40%, more than 12 puffs of SABA on more than two consecutive days or asthma exacerbation during the run-in period.
  7. Participation in another interventional study.
  8. Pregnant or nursing women.
  9. Women of child bearing potential nor using appropriate methods of birth control as defined by protocol

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
Intervention / Treatment
Experimental: BI 671800 (low dose)
Patients receive BI 671800 (low dose) capsules twice daily
Drug: BI 671800
BI 671800
Drug: Fluticasone propionate placebo
Placebo matching Fluticasone propionate
Active Comparator: Fluticasone propionate
Patients inhale from Fluticasone propionate metered dose inhaler (MDI) twice daily
Drug: Fluticasone propionate
Fluticasone propionate
Drug: BI 671800 Placebo
Placebo matching BI 671800
Placebo Comparator: Placebo
Patients receive placebo capsules twice daily
Drug: Fluticasone propionate placebo
Placebo matching Fluticasone propionate
Drug: BI 671800 Placebo
Placebo matching BI 671800
Experimental: BI 671800 (medium dose)
Patients receive BI 671800 (medium dose) capsules twice daily
Drug: BI 671800
BI 671800
Drug: Fluticasone propionate placebo
Placebo matching Fluticasone propionate
Experimental: BI 671800 (high dose)
Patients receive BI 671800 (high dose) capsules twice daily
Drug: BI 671800
BI 671800
Drug: Fluticasone propionate placebo
Placebo matching Fluticasone propionate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced Expiratory Volume in One Second (FEV1) % Predicted Trough Change From Baseline (Mean Observed in the 2 Weeks Prior to Treatment) After Six Weeks of Treatment
Time Frame: Measurements at baseline (mean observed in the 2 weeks prior to treatment) and at week 6 of treatment.

Forced expiratory volume in one second (FEV1) % predicted trough change from baseline (mean observed in the 2 weeks prior to treatment) after 6 weeks of treatment, where trough FEV1 % predicted was defined as the mean of the FEV1 % predicted trough values at 25 minutes and 10 minutes prior to dosing on clinic visit.

MMRM in the statistical test comments is mixed effects model with repeated measures.
Measurements at baseline (mean observed in the 2 weeks prior to treatment) and at week 6 of treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma Control Questionnaire (ACQ) Mean Score Change From Baseline After Six Weeks of Treatment
Time Frame: Measurements at baseline (mean ACQ score obtained at Week 0) and at week 6 of treatment.

Asthma Control Questionnaire (ACQ) mean score change from baseline (mean ACQ score obtained at Week 0) after six weeks of treatment.

The Asthma Control Questionnaire (ACQ) is a patient-reported outcome questionnaire containing 7 items. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore between 0 (well controlled) and 6 (extremely poorly controlled) These questions based on recall of the previous 7 days comprise breathlessness, nocturnal waking, symptoms on waking, activity limitation, wheeze, frequency of short-acting beta-adrenergic (SABA) use, and categorized pre-bronchodilator FEV1% predicted.
Measurements at baseline (mean ACQ score obtained at Week 0) and at week 6 of treatment.

Collaborators and Investigators

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

Sponsor

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)

March 18, 2010

Primary Completion (Actual)

March 26, 2011

Study Completion (Actual)

March 26, 2011

Study Registration Dates

First Submitted

March 19, 2010

First Submitted That Met QC Criteria

March 23, 2010

First Posted (Estimate)

March 24, 2010

Study Record Updates

Last Update Posted (Actual)

May 31, 2022

Last Update Submitted That Met QC Criteria

May 27, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1268.17

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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