BI 671800 ED in Steroid-naive Asthmatic Patients

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

Summary

This is a 6 week study to investigate the effectiveness and safety of BI 671800 ED in patients with asthma who do not take inhaled corticosteroids.

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

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Fluticasone; Xhance

Criteria

Inclusion criteria:

1. Signed informed consent consistent with ICH-GCP

2. Three month history of reversible (12% with 200 mL) asthma (according to GINA) with following spirometry at randomization: FEV1 60%-85%.

3. No ICS previous 3 months prior to screening.

4. Diagnosis of asthma prior to 40 years.

5. 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 PFT

Exclusion criteria:

1. Significant diseases other than asthma or allergic rhinitis.

2. Hepatic transaminases or total bilirubin greater than 1.5 ULN.

3. Hospitalizations for asthma or asthma related intubation within 3 months.

4. Uncontrolled asthma.

5. Respiratory tract infection or exacerbation within 4 weeks.

6. FEV1 less than 40%, more than 12 puffs of 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