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Completed

NCT Number: NCT00308191

A Phase IIIB Study to Compare the Efficacy and Safety of Concomitant Treatment in Patients With COPD

The purpose of this study is to evaluate the safety and efficacy of the concomitant treatment of formoterol fumarate with tiotropium bromide compared to treatment with tiotropium bromide alone.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Medical diagnosis of COPD
  • Current or prior history of cigarette smoking

Exclusion criteria

  • Medical diagnosis of asthma
  • Significant condition or disease other than COPD

Treatment and study plan

formoterol fumarate

Drug

Tiotropium Bromide

Drug

Primary outcomes

  1. Measure of lung Function

Secondary outcomes

  1. Change in lung function, vital signs; physical examinations; clinical laboratory assessments; adverse event reporting; patient questionnaires

Sponsors and collaborators

Lead sponsor

Dey

Industry

Registry information

Official study title

A 6-Week Double-Blind, Parallel-Group, Active-Controlled Trial to Compare the Efficacy and Safety of Concomitant Treatment of Formoterol Fumarate Inhalation Solution 20 Mcg Twice Daily and Tiotropium 18 Mcg Once Daily to Tiotropium 18 Mcg Once Daily Alone in the Treatment of Patients With Chronic Obstructive Pulmonary Disease

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Mar 29, 2006
Registry last updated
Mar 7, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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