Evaluation Inhaled Corticosteroids on Exhaled Nitric Oxide Gas Exchange

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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COPD

Intervention / Treatment
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* Drug: fluticasone 100mcg/ salmeterol 50mcg
* Drug: fluticasone 250/salmeterol 50
* Drug: salmeterol
* Drug: Salmeterol
* Drug: salmeterol and fluticasone propionate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| long acting bronchodilator<br>salmeterol 50mcg bid by DPI, no fluticasone in patients with COPD/emphysema to evaluate effect on bronchodilation and exhaled nitric oxide | Drug: Salmeterol<br>* salmeterol 50mcg bid X 3months<br>* Other names: serevent 50 mcg disk;|
| bronchodilator/ inhaled corticosteroid<br>fluticasone 250mcg/salmeterol 50 mcg bid X 3momths to evaluate effect on lung function and exhaled nitric oxide | Drug: fluticasone 250/salmeterol 50<br>* inhaled fluticasone 250/salmeterol 50 X 3 months to evaluate effect on lung function and exhaled nitric oxide<br>* Other names: Advair 250/50;Drug: salmeterol and fluticasone propionate<br>* salmeterol 50mcg/fluticasone 250mcg by DPI bid<br>* Other names: Advair 250/50;|
| C<br>Fluticasone 100mcg/salmeterol 50mcg | Drug: fluticasone 100mcg/ salmeterol 50mcg<br>* inhaled fluticasone 100mcg/salmeterol 50mcg bid X 3 months<br>* Other names: Advair 100/50;Drug: salmeterol<br>* salmeterol 50 mcg by dry powder inhaler disk bid to evaluated effect on lung function and exhaled nitric oxide<br>* Other names: Serevent 50mcg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total exhaled, bronchial, and small airway/alveolar nitric oxide |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lung function |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic airflow obstruction