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Bi 671800 in Asthmatic Patients on Inhaled Corticosteroids

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BI 671800
Placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. Signed informed consent consistent with International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP) (ICH-GCP)
  2. Three month history of reversible (12% with 200 mL) asthma according to [Global Initiative for Asthma (GINA)] with following spirometry at randomization:forced expiratory volume in 1 second (FEV1) 60%-85%.
  3. Stable inhaled corticosteroid (ICS) dose 3 months prior to screening.
  4. Diagnosis of asthma prior to 40 years.
  5. Asthma Control Questionnaire (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 pulmonary function test (PFT).

Exclusion criteria:

  1. Significant diseases other than asthma or allergic rhinitis.
  2. Hepatic transaminases or total bilirubin greater than 1.5 upper limit of normal (ULN).
  3. Hospitalizations for asthma or asthma related intubation within 3 months.
  4. Uncontrolled asthma on ICS + another controller.
  5. Respiratory tract infection or exacerbation within 4 weeks.
  6. FEV1 less than 40%, more than 12 puffs of short acting beta agonists (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.

Sites / Locations

  • 1268.53.01013 Boehringer Ingelheim Investigational Site
  • 1268.53.01014 Boehringer Ingelheim Investigational Site
  • 1268.53.01002 Boehringer Ingelheim Investigational Site
  • 1268.53.01009 Boehringer Ingelheim Investigational Site
  • 1268.53.01011 Boehringer Ingelheim Investigational Site
  • 1268.53.01001 Boehringer Ingelheim Investigational Site
  • 1268.53.01005 Boehringer Ingelheim Investigational Site
  • 1268.53.01006 Boehringer Ingelheim Investigational Site
  • 1268.53.01007 Boehringer Ingelheim Investigational Site
  • 1268.53.01010 Boehringer Ingelheim Investigational Site
  • 1268.53.01003 Boehringer Ingelheim Investigational Site
  • 1268.53.01008 Boehringer Ingelheim Investigational Site
  • 1268.53.01012 Boehringer Ingelheim Investigational Site
  • 1268.53.01015 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

BI 671800 AM and PM

BI 671800 AM

BI 671800 PM

Placebo

Arm Description

Patients receiving two capsules twice daily

Patients receiving four capsules in the morning

Patients receiving four capsules in the evening

Patients receiving four capsules twice a day

Outcomes

Primary Outcome Measures

Change From Baseline of Trough Forced Expiratory Volume in One Second (FEV1) Percent Predicted After 4 Weeks of Treatment
Trough FEV1 percent (%) predicted was defined as the mean of the morning and the evening FEV1 % predicted daily trough value at the end of the dosing interval. For the morning (evening) measurements, when FEV1 % predicted was available at both 25 minutes and 10 minutes prior to morning (evening) test-drug inhalation, morning (evening) trough FEV1 % predicted was the mean of these two morning (evening) pre-inhalation measurements. Trough FEV1 % predicted change from baseline after 4 weeks of treatment was defined as the change from baseline in the mean of the morning and the evening trough FEV1 % predicted.

Secondary Outcome Measures

Change From Baseline in Asthma Control Questionnaire (ACQ) Mean Score After Four Weeks of Treatment
The Asthma Control Questionnaire (ACQ) consists of 6 patient self-evaluated questions and 1 by clinical staff with each question in 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 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.

Full Information

First Posted
March 18, 2010
Last Updated
May 10, 2022
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT01090024
Brief Title
Bi 671800 in Asthmatic Patients on Inhaled Corticosteroids
Official Title
A Randomised, Double-blind, Placebo-controlled, Efficacy and Safety Cross-over Study of 4 Weeks of Oral BI 671800 ED 200 mg Twice Daily or 400 mg Once Daily Administered in the Morning (AM) or Evening (PM), in Symptomatic Asthma Patients on Inhaled Fluticasone Propionate MDI
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2010 (Actual)
Primary Completion Date
February 1, 2011 (Actual)
Study Completion Date
February 18, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
To investigate the effectiveness and safety of BI 671800 given in the morning (AM), evening (PM) or twice daily (b.i.d.) compared too placebo as add on therapy to inhaled corticosteroid in symptomatic asthma patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BI 671800 AM and PM
Arm Type
Experimental
Arm Description
Patients receiving two capsules twice daily
Arm Title
BI 671800 AM
Arm Type
Experimental
Arm Description
Patients receiving four capsules in the morning
Arm Title
BI 671800 PM
Arm Type
Experimental
Arm Description
Patients receiving four capsules in the evening
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients receiving four capsules twice a day
Intervention Type
Drug
Intervention Name(s)
BI 671800
Intervention Description
BI 671800
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching BI 671800
Primary Outcome Measure Information:
Title
Change From Baseline of Trough Forced Expiratory Volume in One Second (FEV1) Percent Predicted After 4 Weeks of Treatment
Description
Trough FEV1 percent (%) predicted was defined as the mean of the morning and the evening FEV1 % predicted daily trough value at the end of the dosing interval. For the morning (evening) measurements, when FEV1 % predicted was available at both 25 minutes and 10 minutes prior to morning (evening) test-drug inhalation, morning (evening) trough FEV1 % predicted was the mean of these two morning (evening) pre-inhalation measurements. Trough FEV1 % predicted change from baseline after 4 weeks of treatment was defined as the change from baseline in the mean of the morning and the evening trough FEV1 % predicted.
Time Frame
At baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Asthma Control Questionnaire (ACQ) Mean Score After Four Weeks of Treatment
Description
The Asthma Control Questionnaire (ACQ) consists of 6 patient self-evaluated questions and 1 by clinical staff with each question in 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 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.
Time Frame
At baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Signed informed consent consistent with International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP) (ICH-GCP) Three month history of reversible (12% with 200 mL) asthma according to [Global Initiative for Asthma (GINA)] with following spirometry at randomization:forced expiratory volume in 1 second (FEV1) 60%-85%. Stable inhaled corticosteroid (ICS) dose 3 months prior to screening. Diagnosis of asthma prior to 40 years. Asthma Control Questionnaire (ACQ) at least 1.5 at randomization. Male or female, 18 to 65 years. Non-smokers or ex-smokers ( less than 10 pack year history) with negative cotinine screen. Able to perform pulmonary function test (PFT). Exclusion criteria: Significant diseases other than asthma or allergic rhinitis. Hepatic transaminases or total bilirubin greater than 1.5 upper limit of normal (ULN). Hospitalizations for asthma or asthma related intubation within 3 months. Uncontrolled asthma on ICS + another controller. Respiratory tract infection or exacerbation within 4 weeks. FEV1 less than 40%, more than 12 puffs of short acting beta agonists (SABA) on more than two consecutive days or asthma exacerbation during the run-in period. Participation in another interventional study. Pregnant or nursing women. Women of child bearing potential nor using appropriate methods of birth control as defined by protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1268.53.01013 Boehringer Ingelheim Investigational Site
City
Huntington Beach
State/Province
California
Country
United States
Facility Name
1268.53.01014 Boehringer Ingelheim Investigational Site
City
Mission Viejo
State/Province
California
Country
United States
Facility Name
1268.53.01002 Boehringer Ingelheim Investigational Site
City
Stockton
State/Province
California
Country
United States
Facility Name
1268.53.01009 Boehringer Ingelheim Investigational Site
City
Colorado Springs
State/Province
Colorado
Country
United States
Facility Name
1268.53.01011 Boehringer Ingelheim Investigational Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
1268.53.01001 Boehringer Ingelheim Investigational Site
City
North Dartmouth
State/Province
Massachusetts
Country
United States
Facility Name
1268.53.01005 Boehringer Ingelheim Investigational Site
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
1268.53.01006 Boehringer Ingelheim Investigational Site
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
1268.53.01007 Boehringer Ingelheim Investigational Site
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
1268.53.01010 Boehringer Ingelheim Investigational Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
1268.53.01003 Boehringer Ingelheim Investigational Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
1268.53.01008 Boehringer Ingelheim Investigational Site
City
El Paso
State/Province
Texas
Country
United States
Facility Name
1268.53.01012 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
1268.53.01015 Boehringer Ingelheim Investigational Site
City
Richmond
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mystudywindow.com/
Description
Related Info

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Bi 671800 in Asthmatic Patients on Inhaled Corticosteroids

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