A Phase 1 interventional study of budesonide/formoterol fumarate dihydrate inhalation aerosol and DNA methylation analysis in Lung Cancer and Precancerous Condition, sponsored by British Columbia Cancer Agency. Completed at 1 site in Canada. Open to participants aged 45 Years to 74 Years. Per ClinicalTrials.gov, last updated 2012-03-09.
Sponsored by British Columbia Cancer Agency · Phase 1, Interventional, and Treatment
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.
OBJECTIVES:
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's enrollment of 30 is below the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →British Columbia Cancer Agency is the lead sponsor of 149 studies on the registry; 32 are open to participants now.
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DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
Former smoker with a 30 pack-year smoking history and mild to moderate degree of airflow obstruction, meeting the following criterion:
Non-smoker with mild to moderate bronchial asthma not already on inhaled corticosteroids, meeting the following criterion:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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)
Time frame: 24 months
Determination of DNA alterations in bronchial cells
Time frame: 24 months
Correlation of molecular features (e.g., methylation or gene expression changes) with biological features
Time frame: 24 months
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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British Columbia Cancer Agency