UrticariaNCT01091402
Autologous Serum Skin Test and Serum IL-18 Levels in Chronic Idiopathic Urticaria and Respiratory Allergic Diseases
An observational study of Urticaria and Respiratory Allergic Diseases, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
One of the proposed mechanisms in CU is autoimmunity. It was shown by a positive response to autologous serum skin test (ASST)in almost half of chronic urticaria (CU) patients. IL-18 also play a role in autoimmune disorders. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urticaria, Respiratory Allergic Diseases
- What is being tested?
- autologous serum skin test, serum IL-18
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2009to not given
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients from Outpatient clinic
Who may be able to join
- adult patients
- chronic urticaria patients
- stable asthma patients
- allergic rhinitis patients with sensitized to pollens
- normal controls without atopic and skin disease.
Who cannot join
- unwillingness to the study
- other dermatological problems that could affect the skin test
- use of antihistamine drugs
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi University
Eskişehir, 26040
About this study
One of the proposed mechanisms in CU is autoimmunity. It was shown by a positive response to autologous serum skin test (ASST)in almost half of chronic urticaria (CU) patients. IL-18 also play a role in autoimmune disorders. The investigators aim was to investigate the relationship of ASST and IL-18 in CU and respiratory allergic diseases.
- Conditions
- Urticaria, Respiratory Allergic Diseases
- Being tested
- autologous serum skin test, serum IL-18
- Keywords
- autologous serum skin test, IL-18
- Medical subject headings
- Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous serum skin test, serum IL-18Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| chronic urticaria | Not described Receives: Procedure: autologous serum skin test, serum IL-18 | |
| asthma | Not described Receives: Procedure: autologous serum skin test, serum IL-18 | |
| seasonal allergic rhinitis | Not described Receives: Procedure: autologous serum skin test, serum IL-18 | |
| normal controls | Not described Receives: Procedure: autologous serum skin test, serum IL-18 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrticariaStudies 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
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091402
- Sponsor's protocol ID
- 1
- Status last verified
- Jan 2009
- First submitted
- 23 Mar 2010
- Last updated
- 24 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Serum Skin Test and Serum IL-18 Levels in Chronic Idiopathic Urticaria and Respiratory Allergic Diseases
- ClinicalTrials.gov ID
- NCT01091402
- Acronym / sponsor ID
- 1
- Conditions
- Urticaria, Respiratory Allergic Diseases
- Keywords
- autologous serum skin test, IL-18
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- Jan 2009
- First posted
- 24 Mar 2010 (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.
One of the proposed mechanisms in CU is autoimmunity. It was shown by a positive response to autologous serum skin test (ASST)in almost half of chronic urticaria (CU) patients. IL-18 also play a role in autoimmune disorders. The investigators aim was to investigate the relationship of ASST and IL-18 in CU and respiratory allergic diseases.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| chronic urticaria | – | Procedure: autologous serum skin test, serum IL-18 |
| asthma | – | Procedure: autologous serum skin test, serum IL-18 |
| seasonal allergic rhinitis | – | Procedure: autologous serum skin test, serum IL-18 |
| normal controls | – | Procedure: autologous serum skin test, serum IL-18 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients from Outpatient clinic
Key inclusion criteria (5 listed)
- adult patients
- chronic urticaria patients
- stable asthma patients
- allergic rhinitis patients with sensitized to pollens
- normal controls without atopic and skin disease.
Key exclusion criteria (3 listed)
- unwillingness to the study
- other dermatological problems that could affect the skin test
- use of antihistamine drugs
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 |
|---|---|---|
| autologous serum skin test, serum IL-18 | Procedure or surgery | asthma, chronic urticaria, normal controls, seasonal allergic rhinitis |
Primary outcome
Not reported in the source record.
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 24 Mar 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Urticaria and Respiratory Allergic Diseases, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
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 5 inclusion and 3 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 24 Mar 2010. 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 Turkey (Türkiye). 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.
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 24 Mar 2010.