Evaluation Inhaled Corticosteroids on Exhaled Nitric Oxide Gas Exchange

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00568347

Enrollment

Registered

2007-12-06

Start date

2006-01-31

Completion date

2013-10-31

Last updated

2015-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

chronic airflow obstruction

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.

Interventions

DRUGfluticasone 100mcg/ salmeterol 50mcg

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

DRUGfluticasone 250/salmeterol 50

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

DRUGsalmeterol

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

DRUGSalmeterol

salmeterol 50mcg bid X 3months

DRUGsalmeterol and fluticasone propionate

salmeterol 50mcg/fluticasone 250mcg by DPI bid

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
total exhaled, bronchial, and small airway/alveolar nitric oxide	3 months

Secondary

Measure	Time frame
lung function	3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026