Evaluating Genes in Sputum to Measure Drug Response in COPD

NCT00233051 | Terminated

• 1 other identifier: HS-1728
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Emphysema; Chronic Bronchitis

Keywords

Chronic Obstructive Pulmonary Disease (COPD); Emphysema; Chronic Bronchitis; Inhaled Steroid; Salmeterol

Outcome Measures

Primary Outcomes (1)

• Induced Sputum Gene Expression

Secondary Outcomes (1)

• Lung Function

Interventions

Salmeterol or Salmeterol/Fluticasone DRUG

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Jewish Health: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

National Jewish Medical and Research Center

Denver, Colorado, 80206, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema; Bronchitis, Chronic

Interventions

Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Intervention Hierarchy (Ancestors)

Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• E Rand Sutherland, MD, MPH

  National Jewish Medical and Research Center Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 3, 2005
• First Posted: October 5, 2005
• Study Start: April 1, 2003
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: March 29, 2017

Record last verified: 2017-03

Locations

US (1)