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OpenTrials
Completed

NCT Number: NCT00568347

Evaluation Inhaled Corticosteroids on Exhaled Nitric Oxide Gas Exchange

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Arthur F Gelb MD

Lakewood, California, 90712, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fluticasone 100mcg/ salmeterol 50mcg

Drug

inhaled fluticasone 100mcg/salmeterol 50mcg bid X 3 months

Other names: Advair 100/50

fluticasone 250/salmeterol 50

Drug

inhaled fluticasone 250/salmeterol 50 X 3 months to evaluate effect on lung function and exhaled nitric oxide

Other names: Advair 250/50

Salmeterol

Drug

salmeterol 50 mcg by dry powder inhaler disk bid to evaluated effect on lung function and exhaled nitric oxide

Other names: Serevent 50mcg

salmeterol and fluticasone propionate

Drug

salmeterol 50mcg/fluticasone 250mcg by DPI bid

Other names: Advair 250/50

Primary outcomes

  1. total exhaled, bronchial, and small airway/alveolar nitric oxide

    Time frame: 3 months

Secondary outcomes

  1. lung function

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Arthur F Gelb MD

Indiv

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Dec 6, 2007
Registry last updated
Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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