Bi 671800 in Asthmatic Patients on Inhaled Corticosteroids

Boehringer Ingelheim108 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

108

Conditions

Asthma

Interventions

BI 671800DRUG

BI 671800

PlaceboDRUG

Placebo matching BI 671800

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (14)

1268.53.01013 Boehringer Ingelheim Investigational Site

Huntington Beach, California, United States

1268.53.01014 Boehringer Ingelheim Investigational Site

Mission Viejo, California, United States

Outcomes

Primary Outcomes

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.

Time frame: At baseline and 4 weeks

Secondary Outcomes

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.

Time frame: At baseline and 4 weeks

Data from ClinicalTrials.gov

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