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 Drug: salmeterol Drug: Salmeterol Drug: salmeterol and fluticasone propionate

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Diagnostic
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:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 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
Active Comparator: 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
Active Comparator: C 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

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

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gelb AF, George SC, Camacho F, Fraser C, Taylor CF, Shakkottai S. INCREASED PERIPHERAL AIRWAY/ALVEOLAR NITRIC OXIDE IN OLDER NORMALS. Chest. 2010 Aug 12; [Epub ahead of print]

Responsible Party:	Arthur F. Gelb MD
ClinicalTrials.gov Identifier:	NCT00568347 History of Changes
Obsolete Identifiers:	NCT00569348
Other Study ID Numbers:	20061697A
Study First Received:	December 4, 2007
Last Updated:	July 13, 2011
Health Authority:	United States: Institutional Review Board

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

chronic airflow obstruction

Additional relevant MeSH terms:

Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Nitric Oxide
Salmeterol
Fluticasone
Fluticasone, salmeterol drug combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents

Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on February 09, 2012