Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Biomarker/Laboratory analysis, Treatment	Active	45 to 74	Other	BCCA-H06-00209 H06-00209, ZENECA-BCCA-H06-00209, NCT00569712

Objectives

1. 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.
2. 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.
3. 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.

Entry Criteria

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:
    • GOLD class 1 or 2 chronic obstructive pulmonary disease (COPD), defined as a post-bronchodilator FEV₁ < 80% of predicted and FEV₁ to FVC ratio < 70%
  • 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:
    • Fully reversible airflow obstruction and post-bronchodilator FEV₁ > 80% of predicted



• No invasive cancer on bronchoscopy or abnormal spiral chest CT scan suspicious of lung cancer

Prior/Concurrent Therapy:

• More than 6 months since prior and no other concurrent inhaled corticosteroids (e.g., budesonide [Pulmicort Turbuhaler], fluticasone [Flovent], beclomethasone dipropionate [QVAR], or fluticasone/salmeterol [Advair])
• More than 6 months since prior and no concurrent oral steroids (e.g., prednisone)
• No concurrent montelukast
• No concurrent immunomodulatory or immunosuppressive medication (e.g., anti-TNF or methotrexate)
• No concurrent beta-adrenergic blockers (e.g., atenolol or inderal), orally or as eye drops

Patient Characteristics:

• ECOG performance status 0-1
• Not pregnant or nursing
• Fertile patients must use effective contraception
• Willing to use study drug twice daily regularly
• Willing to undergo a bronchoscopy
• Not planning to donate blood during study participation
• No known or suspected hypersensitivity to budesonide, formoterol fumarate dihydrate, or excipients in study drug
• No known reaction to xylocaine
• No history of allergy to Symbicort, Pulmicort, or Oxeze Turbuhaler
• No significant medical condition, such as acute or chronic respiratory failure, unstable angina, uncontrolled congestive heart failure, or bleeding disorder that, in the opinion of the investigator, may either put the patient at risk due to study participation or preclude the patient's ability to complete the study
• No travel or planned hospitalization that would preclude the patient's ability to complete the study

Expected Enrollment

Outcomes

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)
Determination of DNA alterations in bronchial cells
Correlation of molecular features (e.g., methylation or gene expression changes) with biological features
Safety and feasibility

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.

Trial Contact Information

Trial Lead Organizations

British Columbia Cancer Agency - Vancouver Cancer Centre

Stephen Lam, MD, Principal investigator		Ph: 604-675-8089; 800-663-3333

Canada
British Columbia
	Vancouver
	British Columbia Cancer Agency - Vancouver Cancer Centre
		Stephen Lam, MD	Ph:  604-675-8089 800-663-3333

Registry Information
Official Title		A Pilot Comparative Study of the Genomic Molecular and Clinical Profiles of Patients with Lung Cancer, COPD, or Asthma Treated with Symbicort Turbuhaler
Trial Start Date		2007-01-04
Trial Completion Date		2008-03-31 (estimated)
Registered in ClinicalTrials.gov		NCT00569712
Date Submitted to PDQ		2007-11-07
Information Last Verified		2008-12-14

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