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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| long acting bronchodilator | salmeterol 50mcg bid by DPI, no fluticasone in patients with COPD/emphysema to evaluate effect on bronchodilation and exhaled nitric oxide |
| |
| bronchodilator/ inhaled corticosteroid | fluticasone 250mcg/salmeterol 50 mcg bid X 3momths to evaluate effect on lung function and exhaled nitric oxide |
| |
| C | Fluticasone 100mcg/salmeterol 50mcg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluticasone 100mcg/ salmeterol 50mcg | Drug | inhaled fluticasone 100mcg/salmeterol 50mcg bid X 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| total exhaled, bronchial, and small airway/alveolar nitric oxide | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| lung function | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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COPD
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| Name | Affiliation | Role |
|---|---|---|
| Arthur F Gelb, MD | Arthur F Gelb Medical Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthur F Gelb MD | Lakewood | California | 90712 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Gelb AF, Flynn Taylor C, Shinar C. Nitric Oxide gas exchange in COPD. Am J Respir Crit Care Med 2007; 174: A630. | ||
| 20705799 | Derived | Gelb AF, George SC, Camacho F, Fraser C, Flynn Taylor C, Shakkottai S. Increased nitric oxide concentrations in the small airway of older normal subjects. Chest. 2011 Feb;139(2):368-375. doi: 10.1378/chest.10-1157. Epub 2010 Aug 12. | |
| 19820080 |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| D000068299 | Salmeterol Xinafoate |
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| fluticasone 250/salmeterol 50 | Drug | inhaled fluticasone 250/salmeterol 50 X 3 months to evaluate effect on lung function and exhaled nitric oxide |
|
|
| salmeterol | Drug | salmeterol 50 mcg by dry powder inhaler disk bid to evaluated effect on lung function and exhaled nitric oxide |
|
|
| Salmeterol | Drug | salmeterol 50mcg bid X 3months |
|
|
| salmeterol and fluticasone propionate | Drug | salmeterol 50mcg/fluticasone 250mcg by DPI bid |
|
|
| Derived |
| Gelb AF, Flynn Taylor C, Krishnan A, Fraser C, Shinar CM, Schein MJ, Osann K. Central and peripheral airway sites of nitric oxide gas exchange in COPD. Chest. 2010 Mar;137(3):575-84. doi: 10.1378/chest.09-1522. Epub 2009 Oct 9. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |