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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
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
First Received: December 6, 2007   Last Updated: February 13, 2009   History of Changes
Sponsored by: British Columbia Cancer Agency
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00569712
  Purpose

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.


Condition Intervention
Lung Cancer
Precancerous/Nonmalignant Condition
Drug: budesonide/formoterol fumarate dihydrate inhalation aerosol
Genetic: DNA methylation analysis
Genetic: comparative genomic hybridization
Genetic: microarray analysis
Other: bronchoalveolar lavage
Other: immunoenzyme technique
Other: laboratory biomarker analysis
Procedure: bronchoscopy

Study Type: Interventional
Study Design: Treatment, Open Label
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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) [ Designated as safety issue: No ]
  • Determination of DNA alterations in bronchial cells [ Designated as safety issue: No ]
  • Correlation of molecular features (e.g., methylation or gene expression changes) with biological features [ Designated as safety issue: No ]
  • Safety and feasibility [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: January 2007
Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.
  • 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.
  • 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.

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.

  Eligibility

Ages Eligible for Study:   45 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00569712

Locations
Canada, British Columbia
British Columbia Cancer Agency - Vancouver Cancer Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Stephen Lam, MD     604-675-8089        
Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
Principal Investigator: Stephen Lam, MD British Columbia Cancer Agency
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000577434, BCCA-H06-00209, ZENECA-BCCA-H06-00209
Study First Received: December 6, 2007
Last Updated: February 13, 2009
ClinicalTrials.gov Identifier: NCT00569712     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
non-small cell lung cancer
precancerous/nonmalignant condition

Study placed in the following topic categories:
Thoracic Neoplasms
Anti-Inflammatory Agents
Neurotransmitter Agents
Symbicort
Precancerous Conditions
Adrenergic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Adrenergic Agonists
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Neoplasms
Formoterol
Adrenergic beta-Agonists
Budesonide
Asthma
Anti-Asthmatic Agents
Glucocorticoids
Lung Diseases
Non-small Cell Lung Cancer
Peripheral Nervous System Agents
Carcinoma, Non-Small-Cell Lung
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:
Thoracic Neoplasms
Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Symbicort
Precancerous Conditions
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Adrenergic Agonists
Lung Diseases, Obstructive
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Formoterol
Respiratory Tract Neoplasms
Adrenergic beta-Agonists
Budesonide
Anti-Asthmatic Agents
Glucocorticoids
Pharmacologic Actions
Neoplasms
Autonomic Agents
Lung Diseases
Peripheral Nervous System Agents
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on July 02, 2009