Bi 671800 in Asthmatic Patients on Inhaled Corticosteroids

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: BI 671800; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Huntington Beach, California, United States
      • 1268.53.01013 Boehringer Ingelheim Investigational Site
    • Mission Viejo, California, United States
      • 1268.53.01014 Boehringer Ingelheim Investigational Site
    • Stockton, California, United States
      • 1268.53.01002 Boehringer Ingelheim Investigational Site
  • Colorado
    • Colorado Springs, Colorado, United States
      • 1268.53.01009 Boehringer Ingelheim Investigational Site
    • Denver, Colorado, United States
      • 1268.53.01011 Boehringer Ingelheim Investigational Site
  • Massachusetts
    • North Dartmouth, Massachusetts, United States
      • 1268.53.01001 Boehringer Ingelheim Investigational Site
  • Minnesota
    • Minneapolis, Minnesota, United States
      • 1268.53.01005 Boehringer Ingelheim Investigational Site
  • Missouri
    • Saint Louis, Missouri, United States
      • 1268.53.01006 Boehringer Ingelheim Investigational Site
  • North Carolina
    • Raleigh, North Carolina, United States
      • 1268.53.01007 Boehringer Ingelheim Investigational Site
  • Oregon
    • Portland, Oregon, United States
      • 1268.53.01010 Boehringer Ingelheim Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States
      • 1268.53.01003 Boehringer Ingelheim Investigational Site
  • Texas
    • El Paso, Texas, United States
      • 1268.53.01008 Boehringer Ingelheim Investigational Site
    • San Antonio, Texas, United States
      • 1268.53.01012 Boehringer Ingelheim Investigational Site
  • Virginia
    • Richmond, Virginia, United States
      • 1268.53.01015 Boehringer Ingelheim Investigational Site

Participation Criteria

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BI 671800 AM and PM; Patients receiving two capsules twice daily	Drug: BI 671800; BI 671800
EXPERIMENTAL: BI 671800 AM; Patients receiving four capsules in the morning	Drug: BI 671800; BI 671800
EXPERIMENTAL: BI 671800 PM; Patients receiving four capsules in the evening	Drug: BI 671800; BI 671800
PLACEBO_COMPARATOR: Placebo; Patients receiving four capsules twice a day	Drug: Placebo; Placebo matching BI 671800

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline and 4 weeks

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2010
• Primary Completion (ACTUAL): February 1, 2011
• Study Completion (ACTUAL): February 18, 2011

Study Registration Dates

• First Submitted: March 18, 2010
• First Submitted That Met QC Criteria: March 18, 2010
• First Posted (ESTIMATE): March 19, 2010

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 1268.53