Bi 671800 in Asthmatic Patients on Inhaled Corticosteroids

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01090024
• Other study ID #: 1268.53
• Status: Completed
• Phase: Phase 2
• Start date: March 1, 2010
• Est. completion date: February 18, 2011

Study information

• Verified date: May 2022
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: February 18, 2011
• Est. primary completion date: February 1, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• BI 671800
BI 671800
• Placebo
Placebo matching BI 671800

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Related Info