AsthmaNCT01589198
Identification of Molecular Biomarkers to Stratify Patients With Refractory Asthma
An observational study of Asthma, run by National Jewish Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jun 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: We are looking for mild non-smoking asthmatic adults who are well-controlled with their asthma therapy (non-refractory asthmatics).
Who may be able to join
- 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
Who cannot join
- 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)
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- Active or chronic infection
- Hematological or autoimmune disease
- Unable to safely undergo bronchoscopy as determined by doctor or study doctor
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Asthma
- Keywords
- Asthma
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining phenotypes non-invasively
Comparing invasive phenotyping to non-invasive
Measured: October, 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2016
- Study completionJun 2016
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Collaborators
- MedImmune LLC
- Responsible party
- Sponsor
- Investigators
- Richard Martin, MD, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589198
- Sponsor's protocol ID
- NJH HS-2639
- Status last verified
- Mar 2017
- First submitted
- 27 Apr 2012
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Molecular Biomarkers to Stratify Patients With Refractory Asthma
- ClinicalTrials.gov ID
- NCT01589198
- Acronym / sponsor ID
- NJH HS-2639
- Conditions
- Asthma
- Keywords
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Collaborators
- MedImmune LLC
- Study start
- Jan 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 1 May 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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We are looking for mild non-smoking asthmatic adults who are well-controlled with their asthma therapy (non-refractory asthmatics).
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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
Determining phenotypes non-invasively
Time frame: October, 2015
Comparing invasive phenotyping to non-invasive
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 29 Mar 2017.
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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.
Richard Martin, MD principal investigator
National Jewish Health
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 National Jewish Health 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 8 inclusion and 9 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 29 Mar 2017. 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?
Determining phenotypes non-invasively (time frame: October, 2015). 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 29 Mar 2017.