Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma
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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
- Study Primary Completion Date: December 2011
Detailed Clinical Trial Description
Results will be evaluated during exacerbation and when stable following treatment.
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 to moderate dose inhaled corticosteroid, long acting beta 2 agonist, tiotropium
- Experimental: 2
- tapering dose of oral corticosteroid
Outcome Measures for this Clinical Trial
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
- Time Frame: 20-60 days
- 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
- Time Frame: 20-60 days
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
- Time Frame: 20-60 days
- dynamic hyperinflation
- Time Frame: 20-60 days
Safety Issue?: No
- Time Frame: 20-60 days
Criteria for Participation in this Clinical Trial
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: 10 Years
Maximum Age for this Clinical Trial: 85 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Gelb, Arthur F., M.D. Other
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
Related Publications
References
Gelb AF, Zamel N. Unsuspected pseudophysiologic emphysema in chronic persistent asthma. Am J Respir Crit Care Med. 2000 Nov;162(5):1778-82.
Gelb AF, Licuanan J, Shinar CM, Zamel N. Unsuspected loss of lung elastic recoil in chronic persistent asthma. Chest. 2002 Mar;121(3):715-21.
Gelb AF, Gutierrez CA, Weisman IM, Newsom R, Taylor CF, Zamel N. Simplified detection of dynamic hyperinflation. Chest. 2004 Dec;126(6):1855-60.
Gelb AF, Flynn Taylor C, Shinar CM, Gutierrez C, Zamel N. Role of spirometry and exhaled nitric oxide to predict exacerbations in treated asthmatics. Chest. 2006 Jun;129(6):1492-9.
Gelb AF, Taylor CF, Nussbaum E, Gutierrez C, Schein A, Shinar CM, Schein MJ, Epstein JD, Zamel N. Alveolar and airway sites of nitric oxide inflammation in treated asthma. Am J Respir Crit Care Med. 2004 Oct 1;170(7):737-41. Epub 2004 Jun 30.
Gelb AF, Zamel N, Krishnan A. Physiologic similarities and differences between asthma and chronic obstructive pulmonary disease. Curr Opin Pulm Med. 2008 Jan;14(1):24-30. Review.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00576069
