Approach to Predict Steroid Sensitivity in Patients With Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bridgette L Jones, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00811278
First received: December 17, 2008
Last updated: October 7, 2011
Last verified: October 2011
  Purpose

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
Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Non-Invasive Approach to Predict Steroid Sensitivity in Patients With Asthma

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • Validation of this technique as a reliable marker for inflammatory expression related to asthma and corticosteroid response [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood, DNA, RNA


Estimated Enrollment: 30
Study Start Date: December 2008
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
step1
asthma patients on step 1 therapy
step 2
asthma patients on step 2 therapy
healthy
non-asthmatics

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients of the allergy and asthma clinics

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00811278

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

No publications provided

Responsible Party: Bridgette L Jones, Assistant Professor of Pediatrics, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT00811278     History of Changes
Other Study ID Numbers: 08-50
Study First Received: December 17, 2008
Last Updated: October 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
inhaled corticosteroids

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

ClinicalTrials.gov processed this record on April 17, 2014