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BI 671800 in Asthmatic Patients on Inhaled Corticosteroids

NCT01103349 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2022-05-31

Study results available
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Summary

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.

Conditions

Interventions

DRUG

BI 671800

Double blind randomised parallel group study to assess efficacy and tolerability of BI 617800 in patients with symptomatic asthma

DRUG

Placebo

Patients receive placebo capsules and/or encapsulated tablets

DRUG

Montelukast

Double blind randomised parallel group study to assess efficacy and tolerability of BI 671800 in patients with symptomatic asthma

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-20
Primary Completion
2011-08-09
Completion
2011-08-09

Countries

  • United States
  • Austria
  • Germany
  • Italy
  • New Zealand
  • South Korea
  • Sweden
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01103349 on ClinicalTrials.gov