BI 671800 ED in Steroid-naive Asthmatic Patients

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: BI 671800; Drug: Fluticasone propionate; Drug: Fluticasone propionate placebo; Drug: BI 671800 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01092143

1268.17

Details and patient eligibility

About

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.

Enrollment: 389 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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389 participants in 5 patient groups, including a placebo group

BI 671800 (low dose)

Experimental group

Description:

Patients receive BI 671800 (low dose) capsules twice daily

Treatment:

Drug: BI 671800

Drug: Fluticasone propionate placebo

Fluticasone propionate

Active Comparator group

Description:

Patients inhale from Fluticasone propionate metered dose inhaler (MDI) twice daily

Treatment:

Drug: Fluticasone propionate

Drug: BI 671800 Placebo

Placebo

Placebo Comparator group

Description:

Patients receive placebo capsules twice daily

Treatment:

Drug: Fluticasone propionate placebo

Drug: BI 671800 Placebo

BI 671800 (medium dose)

Experimental group

Description:

Patients receive BI 671800 (medium dose) capsules twice daily

Treatment:

Drug: BI 671800

Drug: Fluticasone propionate placebo

BI 671800 (high dose)

Experimental group

Description:

Patients receive BI 671800 (high dose) capsules twice daily

Treatment:

Drug: BI 671800

Drug: Fluticasone propionate placebo