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A Study to Compare the Efficacy and Safety of Different Dosings of Olodaterol Administered With the Respimat® Inhaler in Patients With Moderate to Severe Asthma

NCT01311661 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2014-05-01

Study results available
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Summary

This study will compare efficacy and safety of different regimens of olodaterol administration in asthma (once daily, twice daily) with placebo in a complete cross-over design each within one of the two daily dose groups (medium or high daily dose).

Conditions

Interventions

DRUG

Placebo twice daily

Inhaled Placebo of Olodaterol twice daily

DRUG

Olodaterol low daily dose twice daily

Inhaled Olodaterol medium daily dose administered as low dose twice daily

DRUG

Olodaterol medium daily dose twice daily

Inhaled Olodaterol high daily dose administered as medium dose twice daily

DRUG

Placebo twice daily

Inhaled Placebo of Olodaterol twice daily

DRUG

Olodaterol high daily dose once daily and placebo

Inhaled Olodaterol high daily dose administered as one full dose once daily and placebo once daily

DRUG

Olodaterol medium daily dose once daily and placebo

Inhaled Olodaterol medium daily dose administered as one full dose once daily and placebo once daily

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
2011-03-31
Primary Completion
2011-12-31

Countries

  • United States
  • Austria
  • Germany
  • Hungary
  • Slovakia
  • Slovenia

Study Locations

More Related Trials

Entities

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 NCT01311661 on ClinicalTrials.gov