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Evaluation Inhaled Corticosteroids on Exhaled Nitric Oxide Gas Exchange

Information source: Gelb, Arthur F., M.D.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: COPD

Intervention: fluticasone 100mcg/ salmeterol 50mcg (Drug); fluticasone 250/salmeterol 50 (Drug); salmeterol (Drug); Salmeterol (Drug); salmeterol and fluticasone propionate (Drug)

Phase: N/A

Status: Completed

Sponsored by: Arthur F Gelb MD

Official(s) and/or principal investigator(s):
Arthur F Gelb, MD, Principal Investigator, Affiliation: Arthur F Gelb Medical Corporation

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.

Clinical Details

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 design: Observational Model: Ecologic or Community, Time Perspective: Prospective

Primary outcome: total exhaled, bronchial, and small airway/alveolar nitric oxide

Secondary outcome: lung function

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

Minimum age: 20 Years. Maximum age: 85 Years. Gender(s): Both.

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

Locations and Contacts

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

Starting date: January 2006
Last updated: March 13, 2015

Page last updated: August 23, 2015

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