A Phase I Study in Asthma Patients Evaluating the Effect of Doses of FlutiForm™ on the Amount, if Any, of Cortisol Produced by the Adrenal Glands

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The medications being used in this study are individually approved by the Food and Drug Administration (FDA). The medication under investigation is a combination of the two medications in one inhaler. The purpose of the study is to determine how the medication affects the amount, if any, of cortisol produced by the adrenal glands.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SkyePharma AG
• Collaborator: Abbott
• Treatments: Fluticasone; Formoterol Fumarate; Prednisone

Criteria

Inclusion Criteria:

• Age 18-65 at the Screening Visit;

• History of asthma for at least 6 months prior to Screening Visit

• Well controlled asthma with rescue short acting beta agonist (albuterol) and or stable doses of other medications for at least 4 weeks prior to Screening Visit

• Female subjects that are not pregnant or lactating

• Otherwise healthy as determined by the Investigator.

Exclusion Criteria:

• Life-threatening asthma within the past year or visit to emergency room for asthma in the past 3 months prior to the Screening Visit;

• Significant,nonreversible pulmonary disease (e.g. chronic obstructive pulmonary disease, cystic fibrosis or bronchiectasis)

• Use of any steroid medications, topical or inhaled steroids within 4 weeks or systemic (oral or injectable) steroids within 3 months of dosing

• An upper or lower respiratory tract infection within the last 4 weeks pior to Screening Visit or acute illness or infection within 6 weeks prior to dosing

• Any significant disease or major disorder that may jeopardize subject safety

• History of tabacco use within 6 months prior to dosing and/or smoking history > 10 pack-years

• Female subjects on hormone replacement therapy or using birth control involving hormones in the past 6 months

• Additional inclusion and exclusion criteria will evaluated by the investigator.