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Study in Patients With Asthma

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00215410
Enrollment
36
Registered
2005-09-22
Start date
Unknown
Completion date
2005-10-31
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

Brief summary

The purpose of this study is to determine the most safe and effective dose of the investigational drug in comparison with a control drug and placebo.

Interventions

DRUGFormoterol Fumarate

Sponsors

Dey
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

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

Inclusion criteria

* Children with a history of asthma * Written guardian approval

Exclusion criteria

* Current or recent asthma exacerbation, requiring hospitalization * History of smoking * Debilitating or systemic and/or life-threatening diseases.

Design outcomes

Primary

MeasureTime frame
Measure of lung function

Secondary

MeasureTime frame
Change in lung function, as well as vital signs
Physical Exam results, AE reporting, etc

Countries

United States

Outcome results

None listed

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