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A Pilot Comparative Study of the Genomic Molecular and Clinical Profiles of Patients With Lung Cancer, COPD, or Asthma Treated With Symbicort Turbuhaler


Phase 1
45 Years
74 Years
Not Enrolling
Both
Lung Cancer, Precancerous Condition

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Trial Information

A Pilot Comparative Study of the Genomic Molecular and Clinical Profiles of Patients With Lung Cancer, COPD, or Asthma Treated With Symbicort Turbuhaler


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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)

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

Stephen Lam, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

British Columbia Cancer Agency

Authority:

Canada: Ethics Review Committee

Study ID:

CDR0000577434

NCT ID:

NCT00569712

Start Date:

January 2007

Completion Date:

December 2008

Related Keywords:

  • Lung Cancer
  • Precancerous Condition
  • non-small cell lung cancer
  • precancerous condition
  • Pulmonary Disease, Chronic Obstructive
  • Lung Neoplasms
  • Precancerous Conditions
  • Lung Diseases, Obstructive

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