Study in Subjects Greater Than 40 Years of Age With COPD

NCT00507234 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2010-11-11

No results posted yet for this study

Summary

This is a multicenter, Phase IIIb, randomized, double-blind, active-controlled, parallel-group, comparative study.

The objectives of this study are:

1. To compare the efficacy of tiotropium 18 mcg once daily plus Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg twice daily to tiotropium 18 mcg once daily.
2. To obtain safety data on the use of tiotropium 18 mcg once daily plus FFIS 20 mcg twice daily compared to tiotropium 18 mcg once daily.

Conditions

Interventions

DRUG

formoterol fumarate inhalation solution

Sponsors & Collaborators

  • Dey

    lead INDUSTRY

Principal Investigators

  • Nicola A Hanania, MD · Baylor College of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2007-10-31
Completion
2008-04-30

Countries

  • United States

Study Locations

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Entities

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 NCT00507234 on ClinicalTrials.gov