BI 671800 in Asthmatic Patients on Inhaled Corticosteroids

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Montelukast; Drug: BI 671800; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01103349

2009-014551-80 (EudraCT Number)

1268.16

Details and patient eligibility

About

This is a 6 week study to assess the effect of BI 671800 in patients with asthma. It is a double blind, parallel arm trial testing the safety and efficacy of BI 671800. The main objective is to assess the effect on lung function. The study will also provide data on the pharmacokinetics of BI 671800.

Enrollment: 243 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% and 200 mL in forced expiratory volume in one second - FEV1) asthma (according to GINA) with following spirometry at randomisation: FEV1 60%- 85%.
3. Stable inhaled corticosteroids (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 randomisation.
6. Male or female 18 to 65 years.
7. Non-smokers or ex-smokers (less than 10 pack years history) with negative cotinine screen.
8. Able to perform pulmonary function testing.

Exclusion criteria

1. Significant diseases other than asthma or allergic rhinitis.
2. Hepatic transaminases or total bilirubin greater than 1.5 ULN.
3. Hospitalisation for asthma exacerbation or asthma related intubation within 3 months.
4. Uncontrolled asthma on iCS + other controller.
5. Respiratory tract infection or exacerbation within 4 weeks.
6. FEV1 less than 40%, more than 12 puffs rescue salbutamol on more than two consecutive days, or asthma exacerbation during run-in period.
7. Participation in another interventional study.
8. Pregnant or nursing women.
9. Women of child bearing potential not using appropriate methods of birth control as defined by the study protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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243 participants in 3 patient groups, including a placebo group

BI 671800

Experimental group

Description:

Patients receive BI 671800 capsules twice daily

Treatment:

Drug: BI 671800

Montelukast

Active Comparator group

Description:

Patients receive Montelukast encapsulated tablets once daily

Treatment:

Drug: Montelukast

Placebo

Placebo Comparator group

Description:

Patients receive placebo capsules and/or encapsulated placebo tablets

Treatment:

Drug: Placebo