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Mechanism(s)of Airflow Limitation in Moderate-Severe Persistent Asthma
This study is currently recruiting participants.
Verified by Gelb, Arthur F., M.D., August 2008
First Received: December 17, 2007   Last Updated: August 13, 2008   History of Changes
Sponsored by: Gelb, Arthur F., M.D.
Information provided by: Gelb, Arthur F., M.D.
ClinicalTrials.gov Identifier: NCT00576069
  Purpose

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

MedlinePlus related topics: Asthma Choking
Drug Information available for: Formoterol fumarate Budesonide Arformoterol Formoterol Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate Advair Symbicort Arformoterol Tartrate
U.S. FDA Resources
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

Further study details as provided by Gelb, Arthur F., M.D.:

Primary Outcome 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • investigate the mechanisms that limit expiratory airflow: intrinsic airway obstruction vs loss of lung elastic recoil [ Time Frame: 20-60 days ] [ Designated as safety issue: No ]
  • dynamic hyperinflation [ Time Frame: 20-60 days ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   12 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576069

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

Locations
United States, California
Arthur F Gelb Medical Corporation Recruiting
Lakewood, California, United States, 90712
Principal Investigator: Arthur F Gelb, MD            
Sponsors and Collaborators
Gelb, Arthur F., M.D.
Investigators
Principal Investigator: Arthur F Gelb, MD Arthur F Gelb Medical Corporation
  More Information

Publications:
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

Keywords provided by Gelb, Arthur F., M.D.:
asthma
lung function
inflammation

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009