Repeated High-dose Inhaled Corticosteroids for Asthma

• Status: Withdrawn
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to to compare the effects of high-dose Inhaled Corticosteroids (ICS) vs. placebo in adults with chronic stable asthma.

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

Details

• Lead Sponsor: Johns Hopkins University; University of Chicago
• Treatments: Fluticasone

Criteria

Inclusion criteria:

• Physician diagnosis of asthma.

• Age ≥18 years and ≤50 years

• Evidence of airflow obstruction as measured by spirometry and flow-volume loop per American Thoracic Society guidelines.

• Treatment for asthma with:

• daily inhaled corticosteroids and long-acting beta2-agonists, AND

• as-needed use of a short-acting beta2-agonist

Exclusion criteria:

• History of >10 pack-year tobacco use

• Other pulmonary or cardiac diagnosis that is actively being treated

• History of adverse events or allergy to fluticasone

• Systemic corticosteroid therapy within 7 days of study visit

• Inability to obtain written informed consent