AtopyNCT01489293
Inhibitory Receptors in Eosinophils of Atopic Subjects
An observational study of Atopy and Atopic Dermatitis, run by Meir Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to analyze the expression and activity of inhibitory molecules on eosinophils obtained from allergic subjects. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopy, Atopic Dermatitis, Asthma
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 1 May 2012to 31 Dec 2013
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: allergy clinic
Who may be able to join
- age 20-60 years
- a physician-diagnosed atopic disease
Who cannot join
- atopic disease not active
- steroid treatment
- active non-atopic inflammatory disease, including infections
- pregnancy
Trial locations and contacts
1 site in 1 country.
Israel1 site
Meir Medical Center. Unit of Allergy and Clinical Immunology
Kfar Saba
About this study
Official title: Characterization of the Expression and Activity of Inhibitory Receptors Such as CLM-1 in Eosinophils of Atopic Subjects
The purpose of this study is to analyze the expression and activity of inhibitory molecules on eosinophils obtained from allergic subjects.
- Conditions
- Atopy, Atopic Dermatitis, Asthma, Allergic Rhinitis, Food Allergy
- Medical subject headings
- Dermatitis, Atopic, Asthma, Rhinitis, Allergic, Food Hypersensitivity
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 |
|---|---|---|
| atopic subjects | Patients with one atopic disease or more (atopic dermatitis,rhinitis, asthma, food allergy) | |
| non-atopic subjects | Control group without atopic diseases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of surface molecules on eosinophils as assessed by flow cytometry
Blood samples from donors will be stained and evaluated by flow cytomtery
Measured: December 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2011 (estimated)
- Study start1 May 2012
- Primary completion31 Dec 2013
- Study completion31 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtopyStudies 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
- Other
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alon Y Hershko, MD, PhD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489293
- Sponsor's protocol ID
- MMC110053CTIL
- Status last verified
- Mar 2018
- First submitted
- 7 Dec 2011
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Expression and Activity of Inhibitory Receptors Such as CLM-1 in Eosinophils of Atopic Subjects
- ClinicalTrials.gov ID
- NCT01489293
- Acronym / sponsor ID
- MMC110053CTIL
- Conditions
- Atopy, Atopic Dermatitis, Asthma, Allergic Rhinitis, Food Allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 1 May 2012 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 31 Dec 2013 (actual)
- First posted
- 9 Dec 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 purpose of this study is to analyze the expression and activity of inhibitory molecules on eosinophils obtained from allergic subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| atopic subjects | – | –Patients with one atopic disease or more (atopic dermatitis,rhinitis, asthma, food allergy) |
| non-atopic subjects | – | –Control group without atopic diseases. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- allergy clinic
Key inclusion criteria (2 listed)
- age 20-60 years
- a physician-diagnosed atopic disease
Key exclusion criteria (4 listed)
- atopic disease not active
- steroid treatment
- active non-atopic inflammatory disease, including infections
- 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
Expression of surface molecules on eosinophils as assessed by flow cytometry
Time frame: December 2013
Blood samples from donors will be stained and evaluated by flow cytomtery
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 22 Mar 2018.
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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.
Alon Y Hershko, MD, PhD principal investigator
Meir Medical Center
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 Atopy and Atopic Dermatitis, run by Meir Medical Center at 1 site in Israel.
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 2 inclusion and 4 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 22 Mar 2018. 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 Israel. 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?
Expression of surface molecules on eosinophils as assessed by flow cytometry (time frame: December 2013). 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 22 Mar 2018.