AsthmaNCT01698983
Ex Vivo Stimulation of Whole Blood as a Means to Determine Glucocorticoid Sensitivity to Mild-to-Moderate and Refractory Asthmatics
An observational study of Asthma, run by Jeanette Marketon, MD at 2 sites in United States.
Trial summary
Gluococorticoids are commonly prescribed to treat a number of diseases including the majority of inflammatory diseases. Despite considerable inter-personal variability in responses to glucocorticoids between asthmatics, an insensitivity rate of about 30% and the risk of adverse side effects of glucocorticoid therapy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2011to Oct 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: clinic
Who may be able to join
- To be eligible for the study, subjects must meet all of the following criteria:
- Age ≥ 18 years old
- Physician diagnosis of asthma confirmed through medical record documentation.
- Documented history of 12% FEV1 reversibility post-bronchodilator and/or Methacholine PC 20 score of 16mg/ml or less.
- Non-smoker for > 6 months before enrollment into the trial
- Less than 5 pack year smoking history defined as the average packs smoked per day multiplied by the years of active smoking.
- Willing and able to adhere to the study visit schedule and other protocol-specified procedures.
Who cannot join
- Subjects meeting any of the following criteria may not be enrolled in the study:
- Existence of lung disease (other than asthma)
- Recent asthma exacerbation requiring hospital admissions, unexpected healthcare visits, or prednisone courses in the previous 4 weeks.
- Non-English speaking.
- Participation in another interventional research trial
- Self-reported pregnancy
- Inability or unwillingness to provide consent
- Febrile illness (>38.0˚ C or 100.4˚ F) within 24 hours of visit.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Martha Morehouse Medical Pavillion
Columbus, Ohio, 432211
Martha Morehouse Medical Pavillion
Columbus, Ohio, 43221
About this study
Gluococorticoids are commonly prescribed to treat a number of diseases including the majority of inflammatory diseases. Despite considerable inter-personal variability in responses to glucocorticoids between asthmatics, an insensitivity rate of about 30% and the risk of adverse side effects of glucocorticoid therapy, no assay is currently performed to determine sensitivity in severe and non-severe asthmatics prior to treatment. The purpose of this study is to perform a whole blood ex vivo stimulation assay to interrogate known glucocorticoid receptor (GR) up- and down-regulated genes to indicate glucocorticoid sensitivity and compare the results between severe and non-severe asthmatics.
- Conditions
- Asthma
- Medical subject headings
- Asthma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startJun 2011
- Study completionOct 2012
Why it stopped: data not as expected
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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeanette Marketon, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jeanette Marketon, MD, Ohio State University
- Investigators
- Jeanette Marketon, Ph.D., Principal investigator, Recruit and Consent Patients
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698983
- Sponsor's protocol ID
- 2011H0055
- Status last verified
- Oct 2012
- First submitted
- 1 Oct 2012
- Last updated
- 31 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex Vivo Stimulation of Whole Blood as a Means to Determine Glucocorticoid Sensitivity to Mild-to-Moderate and Refractory Asthmatics
- ClinicalTrials.gov ID
- NCT01698983
- Acronym / sponsor ID
- 2011H0055
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: data not as expected
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Jeanette Marketon, MDUniversity, hospital or other
- Study start
- Jun 2011
- Study completion
- Oct 2012 (actual)
- First posted
- 3 Oct 2012 (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.
Gluococorticoids are commonly prescribed to treat a number of diseases including the majority of inflammatory diseases. Despite considerable inter-personal variability in responses to glucocorticoids between asthmatics, an insensitivity rate of about 30% and the risk of adverse side effects of glucocorticoid therapy, no assay is currently performed to determine sensitivity in severe and non-severe asthmatics prior to treatment. The purpose of this study is to perform a whole blood ex vivo stimulation assay to interrogate known glucocorticoid receptor (GR) up- and down-regulated genes to indicate glucocorticoid sensitivity and compare the results between severe and non-severe asthmatics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- clinic
Key inclusion criteria (7 listed)
- Age ≥ 18 years old
- Physician diagnosis of asthma confirmed through medical record documentation.
- Documented history of 12% FEV1 reversibility post-bronchodilator and/or Methacholine PC 20 score of 16mg/ml or less.
- Non-smoker for > 6 months before enrollment into the trial
- Less than 5 pack year smoking history defined as the average packs smoked per day multiplied by the years of active smoking.
Key exclusion criteria (8 listed)
- Existence of lung disease (other than asthma)
- Recent asthma exacerbation requiring hospital admissions, unexpected healthcare visits, or prednisone courses in the previous 4 weeks.
- Non-English speaking.
- Participation in another interventional research trial
- Self-reported pregnancy
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
Not reported in the source record.
Results and safety
The study was stopped early (reason given: data not as expected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2012.
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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.
Jeanette Marketon, Ph.D. principal investigator
Recruit and Consent Patients
2 sites 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 Jeanette Marketon, MD at 2 sites 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 7 inclusion and 8 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: stopped early, as of the sponsor's last update on 31 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: data not as expected). Results are not available in the source record.
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.
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 31 Oct 2012.