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Evaluation Inhaled Corticosteroids on Exhaled Nitric Oxide Gas Exchange

This study has been terminated.
(Our data in asthmatics JACI 2012; 129(6) 1491-8 reported no significant clinical role for monitoring exhaled NO with respect to response to corticosteroid.)
Sponsor:
Information provided by (Responsible Party):
Arthur F Gelb MD, Gelb, Arthur F., M.D.
ClinicalTrials.gov Identifier:
NCT00568347
First received: December 4, 2007
Last updated: March 1, 2014
Last verified: March 2014
  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:


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
Study Completion Date: October 2013
Primary Completion Date: October 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Arthur F Gelb MD
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):
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
Study First Received: December 4, 2007
Last Updated: March 1, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Albuterol
Fluticasone
Fluticasone, salmeterol drug combination
Nitric Oxide
Salmeterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Antioxidants
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Dermatologic Agents
Endothelium-Dependent Relaxing Factors
Free Radical Scavengers
Gasotransmitters
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on November 23, 2014