Evaluation Inhaled Corticosteroids on Exhaled Nitric Oxide Gas Exchange

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00568347
• Other study ID #: 20061697A
• Status: Completed
• Phase: N/A
• First received: December 4, 2007
• Last updated: March 13, 2015
• Start date: January 2006
• Est. completion date: October 2013

Study information

• Verified date: March 2015
• Source: Gelb, Arthur F., M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00569348

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• COPD

Intervention

Drug:
• fluticasone 100mcg/ salmeterol 50mcg
inhaled fluticasone 100mcg/salmeterol 50mcg bid X 3 months
• fluticasone 250/salmeterol 50
inhaled fluticasone 250/salmeterol 50 X 3 months to evaluate effect on lung function and exhaled nitric oxide
• salmeterol
salmeterol 50 mcg by dry powder inhaler disk bid to evaluated effect on lung function and exhaled nitric oxide
• Salmeterol
salmeterol 50mcg bid X 3months
• salmeterol and fluticasone propionate
salmeterol 50mcg/fluticasone 250mcg by DPI bid

Locations

Country	Name	City	State
United States	Arthur F Gelb MD	Lakewood	California

Sponsors (1)

Lead Sponsor	Collaborator
Arthur F Gelb MD

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gelb AF, Flynn Taylor C, Shinar C. Nitric Oxide gas exchange in COPD. Am J Respir Crit Care Med 2007; 174: A630.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total exhaled, bronchial, and small airway/alveolar nitric oxide		3 months	No
Secondary	lung function		3 months	No