A Pilot Comparative Study of the Genomic Molecular and Clinical Profiles of Patients With Lung Cancer, COPD, or Asthma Treated With Symbicort Turbuhaler
- 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
- 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
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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Changes in the concentrations of cytokines in plasma and bronchoalveolar lavage fluid as well as gene expression profiles before and after treatment with budesonide/formoterol fumarate dihydrate inhalation aerosol (Symbicort Turbuhaler)
Stephen Lam, MD
British Columbia Cancer Agency
Canada: Ethics Review Committee