About this trial
The purpose of this study is to evaluate the site and mechanisms responsible for expiratory airflow limitation in chronic, treated, non-smoking, stable asthmatics with moderate to severe persistent expiratory airflow obstruction. Treatment will include inhaled corticosteroids and long acting beta2agonists. The investigators are interested in determining whether the large and/or small airways are the predominant site of airflow limitation. The investigators are also interested in determining whether intrinsic small airways obstruction and/or loss of lung elastic recoil is responsible for expiratory airflow limitation. The investigators are also interested to evaluate the role of varying doses of inhaled corticosteroids to suppress large and small airway inflammation using exhaled nitric oxide as surrogate markers of inflammation. For comparison purposes, spirometry and measurements of exhaled nitric oxide will also be obtained if possible during a naturally occurring exacerbation of asthma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Current non-smoking (<10 pack yr smoking history)
Stable, treated asthmatics
Age 10-80 yr
post 180ug albuterol by MDI: FEV 1/FVC < 70% and FEV 1 <80% predicted
Disqualifiers
Pregnancy
Trial design
Single group
Treatments tested in this trial
fluticasone/salmeterol in all asthmatics
Drugbudesonide 80ug/formoterol 4.5ug, 2 inhalations bid X 20-60 days or fluticasone 100ug/salmeterol 50ug, 1 inhalation bid X 20-60 days
budesonide/formoterol or fluticasone/salmeterol in all asthmatics
Drugbudesonide 160ug/formoterol 4.5ug, 2 inhalations bid or fluticasone 250ug/salmeterol 50ug, 1 inhalations bid
Treatment groups
Trial outcomes
Primary outcomes
Exhaled nitric oxide
evaluate the role of inhaled corticosteroid on exhaled nitric oxide production in large airways and peripheral small airways/alveoli
Secondary outcomes
Mechanism(s) of expiratory airflow limitation
loss of lung elastic recoil vs intrinsic airway obstruction
Presence of unsuspected emphysema by autopsy or explanted lung
Analysis of lungs obtained at autopsy or explanted lung for extent of emphysema
Sponsors and contacts
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