Evaluation Inhaled Corticosteroids on Exhaled Nitric Oxide Gas Exchange - Full Text View

Sponsor:	Gelb, Arthur F., M.D.
Information provided by:	Gelb, Arthur F., M.D.
ClinicalTrials.gov Identifier:	NCT00568347

Purpose

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	Intervention
COPD	Drug: fluticasone 100mcg/ salmeterol 50mcg Drug: fluticasone 250/salmeterol 50

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Single Blind (Outcomes Assessor), Active Control, Crossover Assignment, Bio-equivalence Study
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

Resource links provided by NLM:

MedlinePlus related topics: Gas

Drug Information available for: Nitric oxide Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate Advair Corticosteroids

U.S. FDA Resources

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

Primary Outcome Measures:

total exhaled, bronchial, and small airway/alveolar nitric oxide [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

lung function [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment:	39
Study Start Date:	January 2006
Estimated Study Completion Date:	March 2008

Arms	Assigned Interventions
A: No Intervention salmeterol only, no fluticasone
B: Active Comparator fluticasone 250mcg/salmeterol 50 mcg bid X 3momths	Drug: fluticasone 250/salmeterol 50 inhaled fluticasone 250/salmeterol 50 X 3 months
C: Active Comparator Fluticasone 100mcg/salmeterol 50mcg	Drug: fluticasone 100mcg/ salmeterol 50mcg inhaled fluticasone 100mcg/salmeterol 50mcg bid X 3 months

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.

Eligibility

Ages Eligible for Study:	40 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568347

Locations

United States, California
Arthur F Gelb MD
Lakewood, California, United States, 90712
Arthur F Gelb MD
Lakewood, California, United States, 90712

Sponsors and Collaborators

Gelb, Arthur F., M.D.

Investigators

Principal Investigator:

Arthur F Gelb, MD

Arthur F Gelb Medical Corporation

More Information

Publications:

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

Responsible Party:	Arthur F. Gelb MD ( Arthur F. Gelb MD )
Study ID Numbers:	20061697A
Study First Received:	December 4, 2007
Last Updated:	December 5, 2007
ClinicalTrials.gov Identifier:	NCT00568347 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Gelb, Arthur F., M.D.:

chronic airflow obstruction

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Vasodilator Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Adrenergic Agonists
Therapeutic Uses
Free Radical Scavengers
Endothelium-Dependent Relaxing Factors
Fluticasone

Dermatologic Agents
Salmeterol
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Cardiovascular Agents
Anti-Allergic Agents
Protective Agents
Pharmacologic Actions
Nitric Oxide
Autonomic Agents
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on February 08, 2010