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Sponsored by: |
Gelb, Arthur F., M.D. |
---|---|
Information provided by: | Gelb, Arthur F., M.D. |
ClinicalTrials.gov Identifier: | NCT00576069 |
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.
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: budesonide/formoterol or fluticasone/salmeterol |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Crossover Assignment, Bio-availability Study |
Official Title: | Evaluation of Mechanism(s)Limiting Expiratory Airflow in Chronic, Stable Asthmatics Who Are Non-Smokers |
Estimated Enrollment: | 40 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
low dose inhaled corticosteroid
|
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
|
2: Experimental
high dose inhaled corticosteroid
|
Drug: budesonide/formoterol or fluticasone/salmeterol
budesonide 160ug/formoterol 4.5ug, 2 inhalations bid or fluticasone 250ug/salmeterol 50ug, 1 inhalations bid
|
Ages Eligible for Study: | 12 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Arthur F Gelb, MD | 562-633-2204 | afgelb@msn.com |
United States, California | |
Arthur F Gelb Medical Corporation | Recruiting |
Lakewood, California, United States, 90712 | |
Principal Investigator: Arthur F Gelb, MD |
Principal Investigator: | Arthur F Gelb, MD | Arthur F Gelb Medical Corporation |
Responsible Party: | Arthur F Gelb Medical Corporation ( Arthur F. Gelb MD ) |
Study ID Numbers: | 20070934 |
Study First Received: | December 17, 2007 |
Last Updated: | August 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00576069 History of Changes |
Health Authority: | United States: Institutional Review Board |
asthma lung function inflammation |
Anti-Inflammatory Agents Neurotransmitter Agents Symbicort Bronchial Diseases Adrenergic Agents Hormone Antagonists Albuterol Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Adrenergic Agonists Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Formoterol |
Fluticasone Salmeterol Adrenergic beta-Agonists Budesonide Asthma Anti-Asthmatic Agents Anti-Allergic Agents Glucocorticoids Inflammation Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Bronchial Diseases Symbicort Albuterol Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Hormones Adrenergic Agonists Hypersensitivity Lung Diseases, Obstructive |
Tocolytic Agents Respiratory Tract Diseases Therapeutic Uses Fluticasone Formoterol Dermatologic Agents Salmeterol Adrenergic beta-Agonists Immune System Diseases Budesonide Asthma Anti-Asthmatic Agents Anti-Allergic Agents Glucocorticoids Pharmacologic Actions |