Evaluation Inhaled Corticosteroids on Exhaled Nitric Oxide Gas Exchange

Arthur F Gelb MD

Status: Completed

Conditions: COPD

Treatments: Drug: fluticasone 100mcg/ salmeterol 50mcg; Drug: salmeterol and fluticasone propionate; Drug: Salmeterol; Drug: salmeterol; Drug: fluticasone 250/salmeterol 50

Study type: Observational

Identifiers

NCT00568347

20061697A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

39 participants in 3 patient groups

long acting bronchodilator

Description:

salmeterol 50mcg bid by DPI, no fluticasone in patients with COPD/emphysema to evaluate effect on bronchodilation and exhaled nitric oxide

Treatment:

Drug: Salmeterol

bronchodilator/ inhaled corticosteroid

Description:

fluticasone 250mcg/salmeterol 50 mcg bid X 3momths to evaluate effect on lung function and exhaled nitric oxide

Treatment:

Drug: fluticasone 250/salmeterol 50

Drug: salmeterol and fluticasone propionate

C

Description:

Fluticasone 100mcg/salmeterol 50mcg

Treatment:

Drug: salmeterol

Drug: fluticasone 100mcg/ salmeterol 50mcg