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 group.

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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

5 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Long Beach, California, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Require the regular use of an inhaled beta-2-selective adrenergic agent.
No clinically significant abnormalities on the medical history, physical examination, and clinical laboratory tests.

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.
Debilitating systemic and/or life-threatening diseases.

Treatment and study plan

formoterol fumarate

Drug

Primary outcomes

Primary: The primary efficacy outcome is measure of lung function.

Secondary outcomes

Secondary: Change in lung function will be examined as a secondary efficacy outcome, as well as vital signs, physical examination, adverse event reporting,etc.

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