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Safety and Efficacy of Arformoterol Tartrate Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease

NCT00250679 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 443

Last updated 2012-06-04

Study results available
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Summary

To evaluate the long-term safety and monitor the long-term efficacy of arformoterol over a period of 6 months in subjects with chronic obstructive pulmonary disease (COPD).

Conditions

Interventions

DRUG

Arformoterol tartrate inhalation solution

Arformoterol 15 ųg BID by nebulization

DRUG

Arformoterol 25 ųg BID

Arformoterol 25 ųg BID by nebulization

DRUG

Formoterol 12 ųg BID

Formoterol fumarate 12 ųg BID via aerolizer/DPI

DRUG

Placebo

Placebo nebule or placebo aerolizer

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

  • Sepracor Medical Director · Sumitomo Pharma America, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2007-10-31
Completion
2007-10-31

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 NCT00250679 on ClinicalTrials.gov