RecruitingPhase 4NCT01225913

Mechanism(s) of Airflow Limitation During Exacerbation of Asthma

Evaluation of Mechanism(s)Limiting Expiratory Airflow in Chronic, Stable Asthmatics Who Are Non-smokers


Sponsor

Gelb, Arthur F., M.D.

Enrollment

50 participants

Start Date

Oct 1, 2007

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 10 YearsMax Age: 80 Years

Inclusion Criteria4

  • 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

Exclusion Criteria1

  • Pregnancy

Interventions

DRUGfluticasone/salmeterol in all asthmatics

budesonide 80ug/formoterol 4.5ug, 2 inhalations bid X 20-60 days or fluticasone 100ug/salmeterol 50ug, 1 inhalation bid X 20-60 days

DRUGbudesonide/formoterol or fluticasone/salmeterol in all asthmatics

budesonide 160ug/formoterol 4.5ug, 2 inhalations bid or fluticasone 250ug/salmeterol 50ug, 1 inhalations bid


Locations(1)

Arthur F Gelb Medical Corporation

Lakewood, California, United States

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NCT01225913


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