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CompletedNCT00569712Updated Mar 9, 2012

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

A Phase 1 interventional study of budesonide/formoterol fumarate dihydrate inhalation aerosol and DNA methylation analysis in Lung Cancer and Precancerous Condition, sponsored by British Columbia Cancer Agency. Completed at 1 site in Canada. Open to participants aged 45 Years to 74 Years. Per ClinicalTrials.gov, last updated 2012-03-09.

Sponsored by British Columbia Cancer Agency · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
45 Years to 74 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lung Cancer
  • Precancerous Condition

Keywords

  • non-small cell lung cancer
  • precancerous condition
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.

This study's enrollment of 30 is below the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

British Columbia Cancer Agency is the lead sponsor of 149 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Interventions

  • Drugbudesonide/formoterol fumarate dihydrate inhalation aerosol
  • GeneticDNA methylation analysis
  • Geneticcomparative genomic hybridization
  • Geneticmicroarray analysis
  • Otherbronchoalveolar lavage
  • Otherimmunoenzyme technique
  • Otherlaboratory biomarker analysis
  • Procedurebronchoscopy
06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 24 months

  2. Determination of DNA alterations in bronchial cells

    Time frame: 24 months

  3. Correlation of molecular features (e.g., methylation or gene expression changes) with biological features

    Time frame: 24 months

07

Study locations

1 site
  • British Columbia Cancer Agency - Vancouver Cancer Centre
    Vancouver, British Columbia V5Z 4E6, Canada
08

References and documents

Publications

  • 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. PubMed 24386300 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00569712
Lead sponsor
British Columbia Cancer Agency
Collaborators
AstraZeneca
Responsible party
Sponsor
First posted
Dec 7, 2007
Start date
Jan 2007
Primary completion
Dec 2008
Completion
Dec 2008
Last update
Mar 9, 2012

Study contacts

Stephen Lam, MD
principal investigator · British Columbia Cancer Agency

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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