Evaluation Inhaled Corticosteroids on Exhaled Nitric Oxide Gas Exchange

Completed

• Conditions: COPD
• Interventions: Drug: fluticasone 100mcg/ salmeterol 50mcg; Drug: fluticasone 250/salmeterol 50; Drug: salmeterol and fluticasone propionate; Drug: Salmeterol

• Registration Number: NCT00568347
• Lead Sponsor: Arthur F Gelb MD

Brief 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.

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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2007-12-04
• Study First Submitted QC: 2007-12-05
• Study First Posted: 2007-12-06
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-13
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
bronchodilator/ inhaled corticosteroid	salmeterol and fluticasone propionate	fluticasone 250mcg/salmeterol 50 mcg bid X 3momths to evaluate effect on lung function and exhaled nitric oxide
C	fluticasone 100mcg/ salmeterol 50mcg	Fluticasone 100mcg/salmeterol 50mcg
bronchodilator/ inhaled corticosteroid	fluticasone 250/salmeterol 50	fluticasone 250mcg/salmeterol 50 mcg bid X 3momths to evaluate effect on lung function and exhaled nitric oxide
C	Salmeterol	Fluticasone 100mcg/salmeterol 50mcg
long acting bronchodilator	Salmeterol	salmeterol 50mcg bid by DPI, no fluticasone in patients with COPD/emphysema to evaluate effect on bronchodilation and exhaled nitric oxide

Primary Outcome Measures

Name	Time	Method
total exhaled, bronchial, and small airway/alveolar nitric oxide	3 months

Secondary Outcome Measures

Name	Time	Method
lung function	3 months

Trial Locations

Locations (1)

Arthur F Gelb MD; 🇺🇸 Lakewood, California, United States