Study in Patients With Asthma

Dey32 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Asthma

Interventions

Formoterol FumarateDRUG

Eligibility

Sex: ALLMin age: 5 YearsMax age: 11 Years

Medical Language ↔ Plain English

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.

Locations (2)

Research Site

Long Beach, California, United States

Research Site

Medford, Oregon, United States

Outcomes

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.

Data from ClinicalTrials.gov

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