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Study in Patients With Asthma

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00215358
Enrollment
32
Registered
2005-09-22
Start date
2002-07-31
Completion date
2005-12-31
Last updated
2010-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, Formoterol, Fumarate, Foradil

Brief summary

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

Interventions

DRUGFormoterol Fumarate

Sponsors

Dey
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
12 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Measure of lung function.

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026