Multiple Rising Dose Study of BI 144807 Powder in Bottle in Mild Asthmatic Patients

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Asthma; Healthy

Treatments: Drug: BI 144807; Drug: Placebo to BI 144807

Study type: Interventional

Funder types: Industry

Identifiers

NCT01651598

1313.2

2012-001615-23 (EudraCT Number)

Details and patient eligibility

About

In this trial the safety, tolerability, pharmacokinetics and exploratory pharmacodynamics of multiple dose administration of BI 144807 will be investigated in otherwise healthy, controlled asthmatic patients

Enrollment: 57 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. mild asthmatic, otherwise healthy subjects (male and female of non-childbearing potential)

Exclusion criteria

1. Apart from mild asthma any relevant deviation from healthy conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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57 participants in 2 patient groups, including a placebo group

BI 144807

Experimental group

Description:

Subjects receive multiple BID doses of BI 144807 solution

Treatment:

Drug: BI 144807

Placebo

Placebo Comparator group

Description:

Subjects receive multiple BID doses of Placebo solution

Treatment:

Drug: Placebo to BI 144807