Identification of Molecular Biomarkers to Stratify Patients With Refractory Asthma
1 other identifier
observational
110
1 country
1
Brief Summary
The purpose of this study is to learn more about asthma in people who are not well-controlled with current asthma medication (refractory asthma). The investigators will compare data from refractory asthmatic patients here at National Jewish Health to mild asthmatics subjects and to people without asthma. Study experiments involve looking at samples from all 3 groups and comparing them at a molecular level. These laboratory experiments may help identify subtypes of refractory asthmatics that require different treatments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 27, 2012
CompletedFirst Posted
Study publicly available on registry
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedMarch 29, 2017
March 1, 2017
4.4 years
April 27, 2012
March 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determining phenotypes non-invasively
Comparing invasive phenotyping to non-invasive
October, 2015
Eligibility Criteria
We are looking for mild non-smoking asthmatic adults who are well-controlled with their asthma therapy (non-refractory asthmatics).
You may qualify if:
- Able to receive Informed Consent
- At least 18 years of age
- ICS \< 880 mcg (FP equivalents)
- PC20\<=16 mg/mL
- No more than 1 oral steroid bursts in previous 12 months
- Less that 3 urgent care visit in previous 12 months
- No deterioration with \<=25% decrease in steroids
- No near fatal asthma event
You may not qualify if:
- Pregnancy
- Current smoker, smoking within the past year or pack/year history \>10 years
- Respiratory infection within past 6 weeks
- Antibiotics within the past 6 weeks
- Active lung disease other than asthma
- Cancer within past 5 years (excluding basal cell skin cancer)
- Active or chronic infection
- Hematological or autoimmune disease
- Unable to safely undergo bronchoscopy as determined by doctor or study doctor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Jewish Healthlead
- MedImmune LLCcollaborator
Study Sites (1)
National Jewish Health
Denver, Colorado, 80121, United States
Biospecimen
Blood and lung samples will be retained for RNA purposes.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Martin, MD
National Jewish Health
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2012
First Posted
May 1, 2012
Study Start
January 1, 2012
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
March 29, 2017
Record last verified: 2017-03