Official Title: “Evaluation of Mechanism(s)Limiting Expiratory Airflow in Chronic, Stable Asthmatics Who Are Non-Smokers”

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. We are interested in determining whether the large and/or small airways are the predominant site of airflow limitation. We are also interested in determining whether intrinsic small airways obstruction and/or loss of lung elastic recoil is responsible for expiratory airflow limitation. We 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.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Crossover Assignment, Bio-availability Study

Study Primary Completion Date: December 2009

Intervention(s) in this Clinical Trial

• Drug: budesonide/formoterol or fluticasone/salmeterol
  • budesonide 80ug/formoterol 4.5ug, 2 inhalations bid X 20-60 days or fluticasone 100ug/salmeterol 50ug, 1 inhalation bid X 20-60 days
• Drug: budesonide/formoterol or fluticasone/salmeterol
  • budesonide 160ug/formoterol 4.5ug, 2 inhalations bid or fluticasone 250ug/salmeterol 50ug, 1 inhalations bid

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • low dose inhaled corticosteroid
• Experimental: 2
  • high dose inhaled corticosteroid

Primary Measures

• use exhaled nitric oxide as a surrogate marker of large airway vs small airway/lung inflammation following various doses of inhaled corticosteroids
  • Time Frame: 20-60 days
    Safety Issue?: No
• determine site of airflow limitation, whether predominantly large and /or small airways using expiratory flow volume curves obtained before and after asthmatics breathe a 80% helium-20% oxygen gas mixture
  • Time Frame: 20-60 days
    Safety Issue?: No

Secondary Measures

• investigate the mechanisms that limit expiratory airflow: intrinsic airway obstruction vs loss of lung elastic recoil
  • Time Frame: 20-60 days
    Safety Issue?: No
• dynamic hyperinflation
  • Time Frame: 20-60 days
    Safety Issue?: No

Inclusion Criteria:

• Current non-smoking (<10 pack yr smoking history)
• Stable, treated asthmatics
• Age 12-80 yr
• post 180ug albuterol by MDI: FEV 1/FVC < 70% and FEV 1 <80% predicted

Exclusion Criteria:

• Pregnancy

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Gelb, Arthur F., M.D.

Overall Clinical Trial Officials and Contacts

Arthur F Gelb, MD Principal Investigator Arthur F Gelb Medical Corporation  

Overall Contact: Arthur F Gelb, MD 562-633-2204 afgelb@msn.com

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00576069

Study ID Number: 20070934

ClinicalTrials.gov Identifier: NCT00576069

Health Authority: United States: Institutional Review Board