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AzTrials

Lung CancerPhase 1NCT00569712

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 study testing budesonide/formoterol fumarate dihydrate inhalation aerosol, DNA methylation analysis and comparative genomic hybridization in people with Lung Cancer and Precancerous Condition, run by British Columbia Cancer Agency at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 74 years
Conditions the study is for
Lung Cancer, Precancerous Condition
What is being tested?
budesonide/formoterol fumarate dihydrate inhalation aerosol, DNA methylation analysis and comparative genomic hybridization
Type of treatment
Surgery or procedure
How many people
30 participants
Where
1 siteCanada
Study dates
Jan 2007to Dec 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • British Columbia Cancer Agency - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

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

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.

Being tested
budesonide/formoterol fumarate dihydrate inhalation aerosol, DNA methylation analysis, comparative genomic hybridization, microarray analysis, bronchoalveolar lavage
Keywords
non-small cell lung cancer, precancerous condition
Medical subject headings
Lung Neoplasms, Precancerous Conditions, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • budesonide/formoterol fumarate dihydrate inhalation aerosolDrug

  • DNA methylation analysisGenetic

  • comparative genomic hybridizationGenetic

  • microarray analysisGenetic

  • bronchoalveolar lavageOther

  • immunoenzyme techniqueOther

  • laboratory biomarker analysisOther

  • bronchoscopyProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 24 months

  2. Determination of DNA alterations in bronchial cells

    Measured: 24 months

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

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionDec 2008
  4. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00569712
Sponsor's protocol ID
CDR0000577434
Other IDs
BCCA-H06-00209, ZENECA-BCCA-H06-00209
Status last verified
Mar 2012
First submitted
6 Dec 2007
Last updated
9 Mar 2012
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing budesonide/formoterol fumarate dihydrate inhalation aerosol, DNA methylation analysis and comparative genomic hybridization in people with Lung Cancer and Precancerous Condition, run by British Columbia Cancer Agency at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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) (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00569712, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2012.

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