Mechanism(s) of Airflow Limitation During Exacerbation of Asthma
Information source: Gelb, Arthur F., M.D.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: budesonide/formoterol or fluticasone/salmeterol in all asthmatics (Drug); budesonide/formoterol or fluticasone/salmeterol in all asthmatics (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Gelb, Arthur F., M.D. Official(s) and/or principal investigator(s): Arthur F Gelb, MD, Principal Investigator, Affiliation: Arthur F Gelb Medical Corporation
Overall contact: Arthur F Gelb, MD, Phone: 562-633-2204, Email: afgelb@msn.com
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.
Clinical Details
Official title: Evaluation of Mechanism(s)Limiting Expiratory Airflow in Chronic, Stable Asthmatics Who Are Non-smokers
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Exhaled nitric oxide
Secondary outcome: site/mechanism(s)airflow limitationdynamic hyperinflation
Detailed description:
In addition we will also obtain above studies in asthmatics during naturally occuring
exacerbation of asthma and following treatment. If available, results of lung function
studies including measurements of lung elastic recoil will be compared to pathologic
analyses of formalin fixed, air inflated lungs obtained at autopsy in asthmatics who die
from asthma related or non-asthma related death. This kind of lung structure-function study
will provide potential mechanism(s) to explain the loss of lung elastic recoil in acute and
chronic asthmatics who are non-smokers. We will also obtain voxel quantification of high
resolution thin section CT of lung obtained without IV contrast. Also, we will use
fiberoptic bronchoscopy to obtain optical coherence tomography in stable asthmatics with
mild to moderate to severe expiratory airflow limitation to assess integrity of the lung
parenchyma.
Eligibility
Minimum age: 10 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- Pregnancy
Locations and Contacts
Arthur F Gelb, MD, Phone: 562-633-2204, Email: afgelb@msn.com
Arthur F Gelb Medical Corporation, Lakewood, California 90712, United States; Recruiting Arthur F Gelb, MD, Principal Investigator
Additional Information
Related publications: 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.
Starting date: October 2007
Last updated: March 13, 2015
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