Bi 671800 in Asthmatic Patients on Inhaled Corticosteroids

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim

Criteria

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.