Study in Patients With Asthma

Dey Pharma

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Formoterol Fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00215371

DL-050

Details and patient eligibility

About

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

Sex: All

Ages: 5 to 11 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind