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

NCT00569712 | Completed Phase 1

• 3 other identifiers: CDR0000577434BCCA-H06-00209ZENECA-BCCA-H06-00209
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer; Precancerous Condition

Keywords

non-small cell lung cancer; precancerous condition

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

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

bronchoscopy PROCEDURE

Eligibility Criteria

• Age: 45 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• AstraZeneca: collaborator

Study Sites (1)

British Columbia Cancer Agency - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Related Publications (1)

• 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.

  PMID: 24386300 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Precancerous Conditions; Carcinoma, Non-Small-Cell Lung

Interventions

Budesonide; DNA Methylation; Comparative Genomic Hybridization; Microarray Analysis; Bronchoalveolar Lavage; Immunoenzyme Techniques; Bronchoscopy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Methylation; Alkylation; Biochemical Phenomena; Chemical Phenomena; Metabolism; Genetic Phenomena; Cytogenetic Analysis; Genetic Techniques; Investigative Techniques; Molecular Diagnostic Techniques; Nucleic Acid Hybridization; Microchip Analytical Procedures; Therapeutic Irrigation; Immunoassay; Immunologic Techniques; Immunohistochemistry; Molecular Probe Techniques; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Stephen Lam, MD

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2007
• First Posted: December 7, 2007
• Study Start: January 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 9, 2012

Record last verified: 2012-03

Locations

CA (1)