Asthma/Steroid Withdrawal Study

• Status: Terminated
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators propose to study the patterns of metabolite changes in subjects with asthma to determine if there is a predictable pattern prior to, and post, clinical exacerbation.

Hypothesis: 1. Metabolite profiles will change prior to detection of a clinical exacerbation in subjects with asthma.

2. There will be a measurable temporal delay before metabolite profiles return to baseline following anti-inflammatory therapy of an exacerbation of asthma.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Alberta
• Collaborator: GlaxoSmithKline
• Treatments: Budesonide

Criteria

Inclusion Criteria:

1. Non-smoker (less than 1 pack-year).

2. Age greater than 18 years old.

3. Ability to obtain informed consent.

4. Pulmonary Function Tests demonstrating greater than 12% FEV1 reversibility following beta agonist OR a methacholine challenge consistent with airways hyper-reactivity.

5. Evidence of atopy on standardized skin test battery.

6. Mild to moderate persistent asthma classification by GINA guidelines.

7. No severe exacerbations in the preceding 3 months (defined as emergency room visit, course of oral prednisone or hospitalization).

8. Access to internet.

Exclusion Criteria:

1. Unstable asthma.

2. Patient not on inhaled corticosteroids.