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

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: British Columbia Cancer Agency
• Collaborators: Astra Zeneca Canada; AstraZeneca
• Treatments: Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Formoterol Fumarate

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 FEV_1 < 80% of predicted and FEV_1 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 FEV_1 > 80% of predicted

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

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

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