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A Pivotal Study of the Safety and Effectiveness of Arformoterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

NCT00685841 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 717

Last updated 2012-11-02

No results posted yet for this study

Summary

A 12 week study to investigate the safety and effectiveness of arformoterol given twice daily compared to placebo in subjects with COPD.

Conditions

Interventions

DRUG

Arformoterol tartrate inhalation solution

Arformoterol 50 mcg QD

DRUG

Arformoterol tartrate inhalation solution

Arformoterol 25 mcg BID

DRUG

Arformoterol tartrate inhalation solution

Arformoterol 15 mcg BID

DRUG

Salmeterol MDI

Salmeterol MDI 42 mcg BID

DRUG

Placebo

Placebo BID MDI

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-02-28
Primary Completion
2003-06-30
Completion
2003-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT00685841 on ClinicalTrials.gov