Studying Genes in Blood and Lung Fluid Samples From Patients With Chronic Obstructive Pulmonary Disease With or Without a Previous Diagnosis of Lung Cancer or With Asthma Treated With Budesonide and Formoterol
Condition: Lung Cancer; Precancerous Condition
MeSH terms: Lung Neoplasms; Precancerous Conditions
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Studying the genes expressed in samples of blood and lung fluid in the laboratory
      from patients receiving budesonide and formoterol may help doctors learn more about the
      effect of budesonide and formoterol on gene expression and biomarkers.

      PURPOSE: This clinical trial is studying genes in blood and lung fluid samples from patients
      with chronic obstructive pulmonary disease, with or without a previous diagnosis of lung
      cancer, or with asthma treated with budesonide and formoterol.
    

Detailed description: 
      OBJECTIVES:

        -  To collect and integrate background information on the genetic, epigenetic, and gene
           expression profiles of small airway cells and markers of inflammation in bronchoalveolar
           lavage fluid and blood from patients with chronic obstructive pulmonary disease (COPD)
           with or without a prior diagnosis of lung cancer and from patients with asthma.

        -  To examine the effects of budesonide/formoterol fumarate dihydrate inhalation aerosol
           (Symbicort Turbuhaler) on methylation and gene expression profiles of airway cells as
           well as on inflammatory, oxidant, and other pathways in these patients.

        -  To determine if it would be feasible to conduct a larger study that would allow a
           definitive analysis of the differences in the bronchial cells and the inflammatory
           proteins in bronchial secretions and blood from patients with COPD with or without a
           prior diagnosis of lung cancer.

      OUTLINE: Patients receive budesonide/formoterol fumarate dihydrate inhalation aerosol
      (Symbicort Turbuhaler) twice daily for 4 weeks in the absence of disease progression or
      unacceptable toxicities.

      Patients undergo blood sample collection and bronchoscopy at baseline and at 4 weeks. Blood
      and bronchoalveolar fluid samples are analyzed for inflammatory biomarker measurements.
      Bronchial brushing cell samples are analyzed by comparative genomic hybridization array,
      whole genome methylation array, and gene expression profiling.

      After completion of study treatment, patients are followed at 1 week by telephone interview.
    

Intervention name(s): budesonide/formoterol fumarate dihydrate inhalation aerosol; DNA methylation analysis; comparative genomic hybridization; microarray analysis; bronchoalveolar lavage; immunoenzyme technique; laboratory biomarker analysis; bronchoscopy
Intervention type(s): Drug; Genetic; Genetic; Genetic; Other; Other; Other; Procedure
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Dimercaprol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: non-small cell lung cancer; precancerous condition