Study in Patients With Asthma

The purpose of this study is to determine which dose of the investigational drug is safest and most effective compared to the control drug.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

12 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Denver, Colorado, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

-Require regular use of an inhaled Beta-2-selective adrenergic agent

Exclusion criteria

Active acute or chronic disorders of the respiratory system within one month prior to screening
Smoking history within the past 12 months or greater than a lifetime 10 pack-year smoking history
Recent surgical interventions such as lung lobectomy or resection (< one year), or cardiothoracic interventions
Life-threatening systemic and debilitating diseases.

Treatment and study plan

formoterol fumarate

Drug

Primary outcomes

Measure of lung function.

Secondary outcomes

Change in lung function, vital signs, physical examinations, clinical laboratory assessments, and adverse event reporting.

Sponsors and collaborators

Lead sponsor

Dey

Industry

Registry information

Important dates

Study start: 2002
Primary completion: 2002
Study completion: 2005
First posted: Sep 22, 2005
Registry last updated: Nov 11, 2010

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.

Published trials that share one or more normalized conditions with this study.

Completed