Evaluating Genes in Sputum to Measure Drug Response in COPD

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

Expression of Inflammatory Mediators in Induced Sputum: A Potential Biomarker of Drug Response in COPD

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00233051
• Other study ID #: HS-1728
• Status: Terminated
• Phase: N/A
• First received: October 3, 2005
• Last updated: March 27, 2017
• Start date: April 2003
• Est. completion date: June 2006

Study information

• Verified date: March 2017
• Source: National Jewish Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to determine whether analysis of genes in sputum is a useful noninvasive technique for measuring response to drugs in patients with COPD.

We propose to use polymerase chain reaction to evaluate gene expression in induced sputum from adult current smokers with moderate COPD, adult former smokers with moderate COPD. This study is designed to determine whether changes in expression of previously-identified inflammatory markers in induced sputum can be detected in response to drug therapy in COPD and to evaluate potential differences in the expression of these markers in adult smokers with and without COPD. Pre- and post-treatment serum will be obtained to facilitate proteomic analysis of therapeutic response as well. Changes in sputum gene expression in response to treatment will be the primary outcome variable in this study. Secondary outcomes will include changes in lung function, as well as changes in induced sputum inflammation. These endpoints will be evaluated before and directly after 6 weeks of randomly-assigned treatment with either salmeterol xinafoate or fluticasone propionate/50mcg salmeterol xinafoate combination DPI bid. Endpoints will be re-evaluated following a 4 week wash-out period.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Twenty adult subjects = 40 years of age and = 10 pack/year cigarette history will be evaluated.

• Subjects will be recruited such that one-half are current smokers and one-half are former smokers.

• All subjects will have COPD (FEV1/FVC < 70% and FEV1 => 40% predicted).

• Airway hyperresponsiveness and diffusion capacity for carbon monoxide will also be performed to more precisely characterize the physiologic phenotype in these subjects.

Exclusion Criteria:

• Subjects will be excluded if they have used inhaled or systemic corticosteroid or antibiotic use within 6 weeks or if they are currently treated with theophylline.

• A 6 weeks run off after an upper respiratory infection will be required for qualifying subjects.

Related Conditions & MeSH terms

• Bronchitis
• Bronchitis, Chronic
• Chronic Bronchitis
• Chronic Obstructive Pulmonary Disease (COPD)
• Emphysema
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Emphysema

Intervention

Drug:
• Salmeterol or Salmeterol/Fluticasone

Locations

Country	Name	City	State
United States	National Jewish Medical and Research Center	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
National Jewish Health	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Induced Sputum Gene Expression
Secondary	Lung Function

External Links

•   clinical lab website within National Jewish Medical and Research Center