AsthmaNCT00811278
Approach to Predict Steroid Sensitivity in Patients With Asthma
An observational study of Asthma, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jun 2011
- Phase
- Observational
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients of the allergy and asthma clinics
Who may be able to join
- healthy control adult subjects (n=10),
- 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.
Who cannot join
- currently smokers or have been smokers in the past 6 months
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-Invasive Approach to Predict Steroid Sensitivity in Patients With Asthma
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.
- Conditions
- Asthma
- Keywords
- inhaled corticosteroids
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| step1 | asthma patients on step 1 therapy | |
| step 2 | asthma patients on step 2 therapy | |
| healthy | non-asthmatics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of this technique as a reliable marker for inflammatory expression related to asthma and corticosteroid response
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bridgette L. Jones, MD, Principal investigator, Children's Mercy Hospital and ClinicsCarrie Vyhlidal, PhD, Principal investigator, Children's Mercy Hospital's and Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811278
- Sponsor's protocol ID
- 08-50
- Status last verified
- Aug 2021
- First submitted
- 17 Dec 2008
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Invasive Approach to Predict Steroid Sensitivity in Patients With Asthma
- ClinicalTrials.gov ID
- NCT00811278
- Acronym / sponsor ID
- 08-50
- Conditions
- Asthma
- Keywords
- inhaled corticosteroids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 18 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| step1 | – | –asthma patients on step 1 therapy |
| step 2 | – | –asthma patients on step 2 therapy |
| healthy | – | –non-asthmatics |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients of the allergy and asthma clinics
Key inclusion criteria (3 listed)
- healthy control adult subjects (n=10),
- 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.
Key exclusion criteria (3 listed)
- currently smokers or have been smokers in the past 6 months
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validation of this technique as a reliable marker for inflammatory expression related to asthma and corticosteroid response
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bridgette L. Jones, MD principal investigator
Children's Mercy Hospital and Clinics
Carrie Vyhlidal, PhD principal investigator
Children's Mercy Hospital's and Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. 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 26 Aug 2021. 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 United States. 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.
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?
Validation of this technique as a reliable marker for inflammatory expression related to asthma and corticosteroid response (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2021.