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Japan Long-term Safety for Tiotropium Plus Olodaterol

NCT01536262 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2015-07-15

Study results available
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Summary

The primary objective of this study is to assess the safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC and olodaterol (delivered by the RESPIMAT Inhaler) in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD).

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Tiotropium + Olodaterol

Tiotropium and Olodaterol FDC once daily inhalation

DEVICE

Respimat

Respimat inhaler

DRUG

Tiotropium + Olodaterol

Tiotropium and Olodaterol FDC once daily inhalation

DRUG

Olodaterol

Olodaterol once daily inhalation

DEVICE

Respimat

Respimat inhaler

DEVICE

Respimat

Respimat inhaler

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

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 NCT01536262 on ClinicalTrials.gov