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Efficacy Safety Study of Arformoterol/Tiotropium Combination Versus Either Therapy Alone in Chronic Obstructive Pulmonary Disease (COPD)

NCT00424528 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2012-06-04

Study results available
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Summary

The purpose of this study is to evaluate and compare the efficacy of arformoterol twice a day and tiotropium once a day (dosed sequentially) versus tiotropium once a day alone in subjects with Chronic Obstructive Pulmonary Disease (COPD).

Conditions

Interventions

DRUG

Arformoterol Tartrate Inhalation Solution

Arformoterol tartrate inhalation solution 15 mcg twice daily and placebo inhalation powder once daily.

DRUG

Tiotropium

Placebo inhalation solution twice daily and tiotropium inhalation powder 18 mcg once daily.

DRUG

Arformoterol and Tiotropium

Arformoterol tartrate inhalation solution 15 mcg twice daily and Tiotropium inhalation powder 18 mcg once daily.

DRUG

Placebo

Placebo inhalation solution and placebo inhalation powder

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

  • William Andrews, M.D. · Sumitomo Pharma America, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00424528 on ClinicalTrials.gov