A Study of 2 Doses of MAP0010 in Adult Asthmatics

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to examine the blood levels of two doses of MAP0010 (a corticosteroid) and two doses of an approved corticosteroid in adult asthma and safety with twice daily dosing over 7 days.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Collaborator: MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
• Treatments: Budesonide

Criteria

Inclusion Criteria:

• Male or female adult asthmatics with mild to moderate persistent asthma.

• 18 to 45 (up to the 46th birthday) years of age.

• Documented diagnosis of asthma at least 3 months prior to Visit 1, per NIH/NHLBI, EPR-3 criteria.

• Able to withhold short-acting bronchodilators (e.g., albuterol or ipratropium bromide) for at least 4 hours prior to clinic visits.

• Baseline FEV1 greater than or equal to 50% of predicted normal.

Exclusion Criteria:

• Any other significant illness/abnormality

• A history of upper or lower respiratory tract infection within 2 weeks

• A history of acute or severe asthma attack requiring ICU admission or ventilatory support.