Approach to Predict Steroid Sensitivity in Patients With Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00811278
Recruitment Status : Completed
First Posted : December 18, 2008
Last Update Posted : October 12, 2011
Information provided by (Responsible Party):
Bridgette L Jones, Children's Mercy Hospital Kansas City

Brief Summary:
Inhaled corticosteroids are widely used as the primary therapy for asthma, which affects approximately 20 million people in the United States. While many patients respond to corticosteroid therapy, as many as 25-30% of patients with severe asthma have asthma that is difficult to treat or steroid insensitive. Predictive biomarkers for the rapid identification of patients with asthma who will achieve adequate control of their symptoms with inhaled corticosteroids has the potential to significantly improve asthma management. This proposal is based on the hypothesis that alterations in gene expression in epithelial cells of the buccal mucosa can be used as a reliable biomarker to predict corticosteroid response in patients with asthma. The goals of this proposal will determine if gene expression in epithelial cells of the buccal mucosa from patients with asthma is in concordance with gene expression profiles that have been identified through more invasive sampling techniques of the airway epithelium of asthma patients. The Specific Aims of this proposal are to 1) investigate the level of variability in gene expression of a subset of inflammatory markers in buccal epithelium from adult patients with asthma. Aim 1 will be carried out by collecting buccal samples from three cohorts of subjects (18-55 years of age) from the Pulmonology and Allergy Clinics at Truman Medical Center during regularly scheduled outpatient visits as follows: 1) healthy control adult subjects (n=10), 2) patients with asthma treated only with a short-acting beta2-agonist (SABA, n=10), and 3) patients with asthma treated with low-dose ICS (n=10). Relative gene expression of inflammatory markers will be determined using quantitative RT (reverse transcription)-PCR and variability in gene expression will be determined within and between the three cohorts. Data from the pilot studies described in this proposal will aid in the determination of appropriate study population sizes for future investigations with the long-term objective to use changes in gene expression (in buccal epithelial cells) as a dynamic biomarker for determining corticosteroid response in patients with asthma.

Condition or disease

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Non-Invasive Approach to Predict Steroid Sensitivity in Patients With Asthma
Study Start Date : December 2008
Actual Primary Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

asthma patients on step 1 therapy
step 2
asthma patients on step 2 therapy

Primary Outcome Measures :
  1. Validation of this technique as a reliable marker for inflammatory expression related to asthma and corticosteroid response [ Time Frame: 6 months ]

Biospecimen Retention:   Samples With DNA
Whole blood, DNA, RNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients of the allergy and asthma clinics

Inclusion Criteria:

  1. healthy control adult subjects (n=10),
  2. patients with mild to moderate asthma (n=20) (Table 2, Appendix 4).

A diagnosis of asthma will be defined as episodic airflow obstruction which is reversible (improvement in FEV1 >12% when measured via spirometry) after administration of a SABA.

Exclusion Criteria:

  1. currently smokers or have been smokers in the past 6 months
  2. a diagnosis of COPD, bronchiectasis, Allergic Bronchopulmonary Aspergillosis, diagnosis of bacterial, fungal, or viral pneumonia in the past 6 months, or other diagnoses of chronic lung disease.
  3. subjects being treated with oral systemic corticosteroids for other diseases, those using intranasal steroids in a 2 week period preceding the study, or those requiring an oral corticosteroid burst in the past 6 weeks, or who are receiving treatment with immune modulator medications will also be excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00811278

United States, Missouri
Truman Medical Center
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Principal Investigator: Bridgette L. Jones, MD Children's Mercy Hospital and Clinics
Principal Investigator: Carrie Vyhlidal, PhD Children's Mercy Hospital's and Clinics

Responsible Party: Bridgette L Jones, Assistant Professor of Pediatrics, Children's Mercy Hospital Kansas City Identifier: NCT00811278     History of Changes
Other Study ID Numbers: 08-50
First Posted: December 18, 2008    Key Record Dates
Last Update Posted: October 12, 2011
Last Verified: October 2011

Keywords provided by Bridgette L Jones, Children's Mercy Hospital Kansas City:
inhaled corticosteroids

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases