NCT00568347

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2007

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

7.8 years

First QC Date

December 4, 2007

Last Update Submit

March 13, 2015

Conditions

COPD

Keywords

chronic airflow obstruction

Outcome Measures

Primary Outcomes (1)

  • total exhaled, bronchial, and small airway/alveolar nitric oxide

    3 months

Secondary Outcomes (1)

  • lung function

    3 months

Study Arms (3)

long acting bronchodilator

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

Drug: Salmeterol

bronchodilator/ inhaled corticosteroid

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

Drug: fluticasone 250/salmeterol 50Drug: salmeterol and fluticasone propionate

C

Fluticasone 100mcg/salmeterol 50mcg

Drug: fluticasone 100mcg/ salmeterol 50mcgDrug: salmeterol

Interventions

fluticasone 100mcg/ salmeterol 50mcgDRUG

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

Also known as: Advair 100/50
C
fluticasone 250/salmeterol 50DRUG

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

Also known as: Advair 250/50
bronchodilator/ inhaled corticosteroid
SalmeterolDRUG

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

Also known as: Serevent 50mcg
C
salmeterol and fluticasone propionateDRUG

salmeterol 50mcg/fluticasone 250mcg by DPI bid

Also known as: Advair 250/50
bronchodilator/ inhaled corticosteroid

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

COPD

You may qualify if:

  • Clinical diagnosis of copd
  • Current non-smoker
  • Not on oral corticosteroids
  • Must be able to use Advair discus or salmeterol discus

You may not qualify if:

  • Pregnancy
  • Current smoker
  • On corticosteroids
  • Clinically unstable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arthur F Gelb MD

Lakewood, California, 90712, United States

Location

Related Publications (3)

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

    RESULT

  • Gelb AF, George SC, Camacho F, Fraser C, Flynn Taylor C, Shakkottai S. Increased nitric oxide concentrations in the small airway of older normal subjects. Chest. 2011 Feb;139(2):368-375. doi: 10.1378/chest.10-1157. Epub 2010 Aug 12.

    PMID: 20705799DERIVED

  • Gelb AF, Flynn Taylor C, Krishnan A, Fraser C, Shinar CM, Schein MJ, Osann K. Central and peripheral airway sites of nitric oxide gas exchange in COPD. Chest. 2010 Mar;137(3):575-84. doi: 10.1378/chest.09-1522. Epub 2009 Oct 9.

    PMID: 19820080DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

FluticasoneSalmeterol XinafoateFluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAlbuterolEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylaminesDrug CombinationsPharmaceutical Preparations

Study Officials

  • Arthur F Gelb, MD

    Arthur F Gelb Medical Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
INDIV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Arthur F Gelb MD

Study Record Dates

First Submitted

December 4, 2007

First Posted

December 6, 2007

Study Start

January 1, 2006

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

US(1)