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A Study of the Safety and Efficacy of 4 Doses of BI 1744 CL Delivered Via the Respimat in Patients With Asthma.

NCT01013753 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2014-06-27

Study results available
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Summary

The primary objective of this study is to determine the efficacy and safety of 4 doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily for four weeks in patients with asthma in comparison to placebo.

Conditions

Interventions

DRUG

Placebo

Determine efficacy and safety of Placebo inhaled once daily from the Respimat inhaler and/or twice daily from the Aerolizer inhaler

DRUG

Olodaterol (BI 1744) high

Determine efficacy and safety in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat

DRUG

Olodaterol (BI 1744) medium

Determination of efficacy in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat

DRUG

Olodaterol (BI 1744) very low

Determination of efficacy in 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat

DRUG

Formoterol 12 mcg

Determine efficacy and safety of 12 mcg Formoterol dose inhaled orally twice daily from the Aerolizer in comparison to other treatment groups

DRUG

Olodaterol (BI 1744) low

Determine efficacy and safety of 4 different doses of Olodaterol (BI 1744) inhaled once daily via the Respimat

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • Austria
  • Germany
  • Poland
  • Romania
  • Slovakia
  • Slovenia

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 NCT01013753 on ClinicalTrials.gov