Safety Study of Arformoterol Tartrate Inhalation Solution in Chronic Obstructive Pulmonary Disease (COPD) Subjects

NCT00909779 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 841

Last updated 2013-11-11

Study results available
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Summary

This is a multi-center study to evaluate the long-term safety of arformoterol 15 mcg twice daily (BID) in the treatment of subjects with moderate-to-severe COPD. Study participation will consist of a total of 6 visits over approximately 1 year.

Conditions

Interventions

DRUG

Arformoterol

Arformoterol Tartrate Inhalation Solution 15 mcg twice daily (BID) for a duration of one year

DRUG

Placebo

Placebo inhalation solution, twice daily (BID) for a duration of one year.

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2012-06-30
Completion
2012-06-30

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 NCT00909779 on ClinicalTrials.gov