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| ID | Type | Description | Link |
|---|---|---|---|
| BCCA-H06-00209 | |||
| ZENECA-BCCA-H06-00209 |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| budesonide/formoterol fumarate dihydrate inhalation aerosol | Drug | |||
| DNA methylation analysis | Genetic | |||
| comparative genomic hybridization | Genetic | |||
| microarray analysis | Genetic | |||
| bronchoalveolar lavage | Other | |||
| immunoenzyme technique | Other | |||
| laboratory biomarker analysis | Other |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 24 months | |
| Determination of DNA alterations in bronchial cells | 24 months | |
| Correlation of molecular features (e.g., methylation or gene expression changes) with biological features | 24 months |
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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:
Former smoker with COPD and has undergone a prior curative resection for stage 0 or I non-small cell lung cancer
Non-smoker with mild to moderate bronchial asthma not already on inhaled corticosteroids, meeting the following criterion:
No invasive cancer on bronchoscopy or abnormal spiral chest CT scan suspicious of lung cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Lam, MD | British Columbia Cancer Agency | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| British Columbia Cancer Agency - Vancouver Cancer Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24386300 | Derived | Um SJ, Lam S, Coxson H, Man SF, Sin DD. Budesonide/formoterol enhances the expression of pro Surfactant Protein-B in lungs of COPD patients. PLoS One. 2013 Dec 26;8(12):e83881. doi: 10.1371/journal.pone.0083881. eCollection 2013. |
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| bronchoscopy | Procedure |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D011230 | Precancerous Conditions |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| D019175 | DNA Methylation |
| D055028 | Comparative Genomic Hybridization |
| D046228 | Microarray Analysis |
| D018893 | Bronchoalveolar Lavage |
| D007124 | Immunoenzyme Techniques |
| D001999 | Bronchoscopy |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D008745 | Methylation |
| D000478 | Alkylation |
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
| D008660 | Metabolism |
| D055614 | Genetic Phenomena |
| D020732 | Cytogenetic Analysis |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D025202 | Molecular Diagnostic Techniques |
| D009693 | Nucleic Acid Hybridization |
| D046208 | Microchip Analytical Procedures |
| D007507 | Therapeutic Irrigation |
| D007118 | Immunoassay |
| D007158 | Immunologic Techniques |
| D007150 | Immunohistochemistry |
| D015336 | Molecular Probe Techniques |
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013510 | Pulmonary Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
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