AsthmaNCT01334853
A Study to Assess Selected Biomarkers in Subjects Requiring Daily Inhaled Corticosteroids for Persistent Asthma
An observational study of Asthma, run by MedImmune LLC at 18 sites in 2 countries.
Trial summary
The rationale for conducting this study is to explore potential clinical and peripheral biomarkers in subjects requiring daily medium to high dose inhaled corticosteroids for persistent asthma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- No drug will be used
- How many people
- 97 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Jan 2011to Sep 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with asthma on stable medium- to high-dose inhaled corticosteroids.
Who may be able to join
- Age 18 through 75 at the time of screening
- Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- History of physician-diagnosed asthma for at least 12 months prior to screening
- Stable Medium- to high-dose ICS divided twice daily as outlined by the NHLBI Asthma Guidelines, 2007
Who cannot join
- Any medical condition that, in the opinion of the investigator or medical monitor, would interfere with interpretation of subject safety or study results
- Concurrent enrollment in another clinical study
- Use of immunosuppressive medication within 3 months prior to screening
- Acute upper or lower respiratory infections requiring antibiotics or antiviral medications with in 30 days prior to screening or during screning period.
- Receipt of immunoglobulin or blood products within 30 days prior to screening or during the screening period
- Receipt of any investigational non-biological drug therapy within 30 days or 5 half-lives prior to screening whichever is longer; or receipt of any marketed or investigational biologic within 6 months or 5 half-lives prior to screening whichever is longer
Show all 10Show fewer
- Pregnant, lactating, or breastfeeding woman
- Diagnosis of lung disease other than persistent asthma
- History of smoking ≥10 pack years or any smoking within 12 months prior to screening
- History of active, infectious hepatitis A, B, C or human immunodeficiency virus (HIV)
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
United States12 sites
Research Site
Ann Arbor, Michigan
Research Site
Baltimore, Maryland
Research Site
Chapel Hill, North Carolina
Research Site
Columbus, Ohio
Research Site
Denver, Colorado
Research Site
Galveston, Texas
Research Site
Houston, Texas
Research Site
Madison, Wisconsin
Research Site
Normal, Illinois
Research Site
Pittsburgh, Pennsylvania
Research site
Rochester, Minnesota
Research Site
St Louis, Missouri
Canada6 sites
Research Site
Calgary, Alberta
Research Site
Edmonton, Alberta
Research Site
Montreal, Quebec
Research Site
Québec, Quebec
Research Site
Toronto, Ontario
Research Site
Vancouver, British Columbia
About this study
Official title: A Prospective Observational Study to Assess the Role of Selected Biomarkers in Subjects Requiring Daily Medium- to High-dose Inhaled Corticosteroids for Persistent Asthma
The rationale for conducting this study is to explore potential clinical and peripheral biomarkers in subjects requiring daily medium to high dose inhaled corticosteroids for persistent asthma
- Conditions
- Asthma
- Being tested
- No drug will be used
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No drug will be usedOther
Biomarker
No drug will be usedOther
Biomarker
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | 50 eosinophilic subjects to be evaluated Receives: Other: No drug will be used | |
| Cohort 2 | 50 non-eosinophilic subjects to be evaluated Receives: Other: No drug will be used |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify an optimal prediction rule for classifying sputum eosinophilic and non-eosinophilic asthmatics.
Variables representing lung function tests, patient reported outcomes, and blood biomarkers will be evaluated singly and in various combinations.
Measured: 8 Days
Secondary outcomes (5)
To assess which markers are associated with sputum eosinophils.
Comparing lung function tests between eosinophilic and non-eosinophilic subjects.
Measured: 8 Days
To assess which markers are associated with sputum eosinophils
Comparing blood biomarkers between eosinophilic and non-eosinophilic subjects
Measured: 8 Days
To assess which markers are associated with sputum esonophils
Comparing sputum biomarkers bewteen eosinophilic and non-eosinophilic subjects
Measured: 8 Days
To assess which markers are associated with sputum eosinophils.
Comparing patient reported outcomes between eosinophilic and non-eosinophilic subjects.
Measured: 8 Days
To evaluate transcript expression profiles in whole blood and/or sputum using microarray analyses
Measured: 8 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startJan 2011
- Primary completionApr 2012
- Study completionSep 2012
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
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Gossage, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334853
- Sponsor's protocol ID
- MI-CP223
- Status last verified
- Oct 2012
- First submitted
- 28 Mar 2011
- Last updated
- 11 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study to Assess the Role of Selected Biomarkers in Subjects Requiring Daily Medium- to High-dose Inhaled Corticosteroids for Persistent Asthma
- ClinicalTrials.gov ID
- NCT01334853
- Acronym / sponsor ID
- MI-CP223
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 13 Apr 2011 (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 rationale for conducting this study is to explore potential clinical and peripheral biomarkers in subjects requiring daily medium to high dose inhaled corticosteroids for persistent asthma
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: No drug will be used50 eosinophilic subjects to be evaluated |
| Cohort 2 | – | Other: No drug will be used50 non-eosinophilic subjects to be evaluated |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with asthma on stable medium- to high-dose inhaled corticosteroids.
Key inclusion criteria (4 listed)
- Age 18 through 75 at the time of screening
- Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- History of physician-diagnosed asthma for at least 12 months prior to screening
- Stable Medium- to high-dose ICS divided twice daily as outlined by the NHLBI Asthma Guidelines, 2007
Key exclusion criteria (10 listed)
- Any medical condition that, in the opinion of the investigator or medical monitor, would interfere with interpretation of subject safety or study results
- Concurrent enrollment in another clinical study
- Use of immunosuppressive medication within 3 months prior to screening
- Acute upper or lower respiratory infections requiring antibiotics or antiviral medications with in 30 days prior to screening or during screning period.
- Receipt of immunoglobulin or blood products within 30 days prior to screening or during the screening period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No drug will be usedBiomarker | Other | Cohort 1 |
| No drug will be usedBiomarker | Other | Cohort 2 |
Primary outcome
To identify an optimal prediction rule for classifying sputum eosinophilic and non-eosinophilic asthmatics.
Time frame: 8 Days
Variables representing lung function tests, patient reported outcomes, and blood biomarkers will be evaluated singly and in various combinations.
5 secondary outcomes
To assess which markers are associated with sputum eosinophils.
Time frame: 8 Days
To assess which markers are associated with sputum eosinophils
Time frame: 8 Days
To assess which markers are associated with sputum esonophils
Time frame: 8 Days
To assess which markers are associated with sputum eosinophils.
Time frame: 8 Days
To evaluate transcript expression profiles in whole blood and/or sputum using microarray analyses
Time frame: 8 Days
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 11 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.
David Gossage, M.D. study director
MedImmune LLC
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by MedImmune LLC at 18 sites in 2 countries.
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 4 inclusion and 10 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 11 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 18 sites in United States, Canada. 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?
To identify an optimal prediction rule for classifying sputum eosinophilic and non-eosinophilic asthmatics. (time frame: 8 Days). 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 11 Oct 2012.