Clinical trial · Interventional
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 Pilot Comparative Study of the Genomic Molecular and Clinical Profiles of Patients With Lung Cancer, COPD, or Asthma Treated With Symbicort Turbuhaler
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bronchoalveolar lavage | Other | — | UNRESOLVED |
| bronchoscopy | Procedure | — | UNRESOLVED |
| budesonide/formoterol fumarate dihydrate inhalation aerosol | Drug | — | UNRESOLVED |
| comparative genomic hybridization | Genetic | — | UNRESOLVED |
| DNA methylation analysis | Genetic | — | UNRESOLVED |
| immunoenzyme technique | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| microarray analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- 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)
- timeFrame
- 24 months
- measure
- Determination of DNA alterations in bronchial cells
- timeFrame
- 24 months
- measure
- Correlation of molecular features (e.g., methylation or gene expression changes) with biological features
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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 dropsReferences
Publications (1)
- DERIVEDUm 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