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Efficacy Safety Study of Arformoterol QD Dosing Versus BID Dosing in COPD

NCT00571428 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2012-02-22

Study results available
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Summary

To evaluate the efficacy and safety of arformoterol tartrate inhalation solution 30μg/4mL QD (two 15μg/2mL dosed in combination) over a 24-hour period compared to arformoterol tartrate inhalation solution 15μg/2 mL BID in subjects with COPD.

Conditions

Interventions

DRUG

Arformoterol Tartrate Inhalation Solution

Nebulized arformoterol tartrate inhalation solution 15 microgram twice a day (BID)

DRUG

Arformoterol Tartrate Inhalation Solution

Nebulized arformoterol tartrate inhalation solution 30 microgram once a day (QD)

DRUG

Placebo

Placebo inhalation solution (citrate buffered 0.9% saline solution) once a day

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

  • Pulmonary Medical Director · Sumitomo Pharma America, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-03-31
Completion
2008-03-31

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 NCT00571428 on ClinicalTrials.gov