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Evaluation Inhaled Corticosteroids on Exhaled Nitric Oxide Gas Exchange

This study has been terminated.
(Our data in asthmatics JACI 2012; 129(6) 1491-8 reported no significant clinical role for monitoring exhaled NO with respect to response to corticosteroid.)
Sponsor:
Information provided by (Responsible Party):
Arthur F Gelb MD, Gelb, Arthur F., M.D.
ClinicalTrials.gov Identifier:
NCT00568347
First received: December 4, 2007
Last updated: March 1, 2014
Last verified: March 2014

December 4, 2007
March 1, 2014
January 2006
October 2013   (final data collection date for primary outcome measure)
total exhaled, bronchial, and small airway/alveolar nitric oxide [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00568347 on ClinicalTrials.gov Archive Site
lung function [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
COPD
  • Drug: fluticasone 100mcg/ salmeterol 50mcg
    inhaled fluticasone 100mcg/salmeterol 50mcg bid X 3 months
    Other Name: Advair 100/50
  • Drug: fluticasone 250/salmeterol 50
    inhaled fluticasone 250/salmeterol 50 X 3 months to evaluate effect on lung function and exhaled nitric oxide
    Other Name: Advair 250/50
  • Drug: salmeterol
    salmeterol 50 mcg by dry powder inhaler disk bid to evaluated effect on lung function and exhaled nitric oxide
    Other Name: Serevent 50mcg
  • Drug: Salmeterol
    salmeterol 50mcg bid X 3months
    Other Name: serevent 50 mcg disk
  • Drug: salmeterol and fluticasone propionate
    salmeterol 50mcg/fluticasone 250mcg by DPI bid
    Other Name: Advair 250/50
  • Active Comparator: long acting bronchodilator
    salmeterol 50mcg bid by DPI, no fluticasone in patients with COPD/emphysema to evaluate effect on bronchodilation and exhaled nitric oxide
    Intervention: Drug: Salmeterol
  • Active Comparator: bronchodilator/ inhaled corticosteroid
    fluticasone 250mcg/salmeterol 50 mcg bid X 3momths to evaluate effect on lung function and exhaled nitric oxide
    Interventions:
    • Drug: fluticasone 250/salmeterol 50
    • Drug: salmeterol and fluticasone propionate
  • Active Comparator: C
    Fluticasone 100mcg/salmeterol 50mcg
    Interventions:
    • Drug: fluticasone 100mcg/ salmeterol 50mcg
    • Drug: salmeterol

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
39
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
40 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00568347
20061697A
Yes
Arthur F Gelb MD, Gelb, Arthur F., M.D.
Arthur F Gelb MD
Not Provided
Principal Investigator: Arthur F Gelb, MD Arthur F Gelb Medical Corporation
Gelb, Arthur F., M.D.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP