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Evaluation Inhaled Corticosteroids on Exhaled Nitric Oxide Gas Exchange

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ClinicalTrials.gov Identifier: NCT00568347
Recruitment Status : Completed
First Posted : December 6, 2007
Last Update Posted : March 17, 2015
Information provided by (Responsible Party):
Arthur F Gelb MD, Gelb, Arthur F., M.D.

Brief Summary:
To evaluate the role of inhaled corticosteroids to suppress nitric oxide gas exchange in stable patients with moderate-to-severe COPD who are current non-smokers and not on oral corticosteroids.

Condition or disease Intervention/treatment
COPD Drug: fluticasone 100mcg/ salmeterol 50mcg Drug: fluticasone 250/salmeterol 50 Drug: salmeterol Drug: Salmeterol Drug: salmeterol and fluticasone propionate

Detailed Description:
Stable, non-smoking COPD patients not on oral corticosteroids will be randomized in single blinded study to evaluate nitric oxide gas exchange at baseline, and subsequent effects of fluticasone 100mcg/salmeterol 50mcg bid, and fluticasone 250mcg/salmeterol 50mcg bid. Primary end points will include measurements of nitric oxide at varying expiratory flow rates to calculate bronchial, and small airway/alveolar nitric oxide. Secondary end points will evaluate lung function. Exhaled nitric oxide production presumably reflects endogenous inflammation. Normal healthy, non-smoking controls will be used for comparison, with exhaled nitric oxide measured before and after 3 weeks of low dose inhlaed corticosteroids.

Study Type : Observational
Actual Enrollment : 39 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Evaluation of the Effects of Varying Doses of Inhaled Corticosteroids on Suppression of Total Exhaled, Bronchial, and Alveolar Nitric Oxide as Markers of Endogenous Inflammation in Patients With Moderate-to-severe COPD
Study Start Date : January 2006
Primary Completion Date : October 2013
Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids
U.S. FDA Resources

Group/Cohort Intervention/treatment
long acting bronchodilator
salmeterol 50mcg bid by DPI, no fluticasone in patients with COPD/emphysema to evaluate effect on bronchodilation and exhaled nitric oxide
Drug: Salmeterol
salmeterol 50mcg bid X 3months
Other Name: serevent 50 mcg disk
bronchodilator/ inhaled corticosteroid
fluticasone 250mcg/salmeterol 50 mcg bid X 3momths to evaluate effect on lung function and exhaled nitric oxide
Drug: fluticasone 250/salmeterol 50
inhaled fluticasone 250/salmeterol 50 X 3 months to evaluate effect on lung function and exhaled nitric oxide
Other Name: Advair 250/50
Drug: salmeterol and fluticasone propionate
salmeterol 50mcg/fluticasone 250mcg by DPI bid
Other Name: Advair 250/50
Fluticasone 100mcg/salmeterol 50mcg
Drug: fluticasone 100mcg/ salmeterol 50mcg
inhaled fluticasone 100mcg/salmeterol 50mcg bid X 3 months
Other Name: Advair 100/50
Drug: salmeterol
salmeterol 50 mcg by dry powder inhaler disk bid to evaluated effect on lung function and exhaled nitric oxide
Other Name: Serevent 50mcg

Primary Outcome Measures :
  1. total exhaled, bronchial, and small airway/alveolar nitric oxide [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. lung function [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Inclusion Criteria:

  • Clinical diagnosis of copd
  • Current non-smoker
  • Not on oral corticosteroids
  • Must be able to use Advair discus or salmeterol discus

Exclusion Criteria:

  • Pregnancy
  • Current smoker
  • On corticosteroids
  • Clinically unstable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00568347

United States, California
Arthur F Gelb MD
Lakewood, California, United States, 90712
Sponsors and Collaborators
Arthur F Gelb MD
Principal Investigator: Arthur F Gelb, MD Arthur F Gelb Medical Corporation

Gelb AF, Flynn Taylor C, Shinar C. Nitric Oxide gas exchange in COPD. Am J Respir Crit Care Med 2007; 174: A630.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arthur F Gelb MD, Gelb, Arthur F., M.D.
ClinicalTrials.gov Identifier: NCT00568347     History of Changes
Obsolete Identifiers: NCT00569348
Other Study ID Numbers: 20061697A
First Posted: December 6, 2007    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015

Keywords provided by Arthur F Gelb MD, Gelb, Arthur F., M.D.:
chronic airflow obstruction

Additional relevant MeSH terms:
Salmeterol Xinafoate
Nitric Oxide
Bronchodilator Agents
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Free Radical Scavengers
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Protective Agents
Hormones, Hormone Substitutes, and Hormone Antagonists