Study of the Mechanisms of Asthma

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to identify the causes of asthma that were not previously suspected, to better understand the effects of inhaled steroids on asthma and to identify new way to treat asthma. In order to take advantage of the most current scientific expertise, we (scientists at UCSF) plan to work together with Genentech Inc. We believe that working with Genentech will provide the best chance of developing new treatments for asthma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: Genentech, Inc.
• Treatments: Budesonide

Criteria

Inclusion Criteria:

Group C:

• Male and female subjects between the ages of 18 and 70 years

• History of asthma

• Continuous treatment with inhaled corticosteroids for at least the 6-week

• Hyperreactivity to methacholine (provocative concentration of methacholine causing a 20% drop in forced expiratory volume in 1 second (PC20 FEV1) Methacholine ≤ 16.0 mg/mL).

Exclusion Criteria:

• History of asthma

• No use of oral or inhaled corticosteroids for the treatment of asthma in the past 6 weeks

• Hyperreactivity to methacholine (PC20 FEV1 Methacholine ≤ 8.0 mg/mL).

• At least one of the following symptoms, beta agonist use, or FEV1 criteria:

• Asthma symptoms on at least two days per week; OR

• Beta agonist use on at least two days per week; OR

• Forced expiratory volume in 1 second (FEV1) < 85% predicted

• Subjects must be non-smokers (patients who have never smoked or patients who have not smoked for 1 year and have a total pack-year smoking history < 15 packs).