Allergic RhinitisNCT04352088
Immune Response Features in Allergic Airway Diseases
An observational study of Allergic Rhinitis and Allergic Asthma, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial summary
This study aims to investigate immune mechanisms and phenotypes and endotypes of allergic airway diseases - allergic rhinitis and allergic asthma. Pathogenesis of these diseases are not fully investigated yet. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis, Allergic Asthma
- What is being tested?
- Nasal provocation test
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteLithuania
- Study dates
- 1 May 2019to Apr 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients with allergic rhinitis with or without asthma and healthy individuals for control group.
Who may be able to join
- Hypersensitivity to house dust mites
- Allergic rhinitis with or without mild to moderate asthma
Who cannot join
- Acute or chronic infections
- Use of systemic immunosupresants (wait 1 month)
- Use of systemic or local antihistamines (wait 1 week)
- Use of intranasal steroids (wait 1 month)
- Oncological or active autoimmune diseases
Trial locations and contacts
1 site in 1 country.
Brigita Sitkauskiene contact
Lithuania1 site, 1 recruiting
- Recruiting
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas
Tomas Lapinskas, PhD, tomas.lapinskas@kaunoklinikos.lt
About this study
Official title: Investigation of Phenotypes, Endotypes and Immune Response Features in Allergic Airway Diseases
This study aims to investigate immune mechanisms and phenotypes and endotypes of allergic airway diseases - allergic rhinitis and allergic asthma. Pathogenesis of these diseases are not fully investigated yet. Patients with the same disease have different dominant symptoms, course of the disease and response to treatment. Moreover, there is a hypothesis about united airway disease suggesting that allergic rhinitis and allergic asthma is different manifestation of the same disease. This led to assumption of phenotypes and endotypes. This classification which still is not unified can let to prescribe personalized treatment for every patient.
- Conditions
- Allergic Rhinitis, Allergic Asthma
- Being tested
- Nasal provocation test
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal provocation testProcedure or surgery
Allergen extract under controlled conditions will be applied into nasal mucous.
| Study group | Role | What they receive |
|---|---|---|
| Allergic rhinitis patients | Not described Receives: Procedure: Nasal provocation test | |
| Allergic rhinitis and asthma patients | Not described Receives: Procedure: Nasal provocation test | |
| Healthy individuals | Not described Receives: Procedure: Nasal provocation test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokines level in nasal lavage and peripheral blood after nasal provocation test in different groups.
Cytokines (IL-13, IL-10, IL-22, etc.) level will be measured by ELISA before and after nasal provocation test with house dust mites.
Comparison between different groups.
Measured: 2 hours
Cytokines level in nasal lavage and peripheral blood after nasal provocation test in different groups.
Cytokines (IL-13, IL-10, IL-22, etc.) level will be measured by ELISA before and after nasal provocation test with house dust mites.
Measured: 22 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start1 May 2019
- Primary completionNov 2022 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brigita Sitkauskiene, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352088
- Sponsor's protocol ID
- AKTL1
- Status last verified
- Apr 2020
- First submitted
- 15 Apr 2020
- Last updated
- 17 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Phenotypes, Endotypes and Immune Response Features in Allergic Airway Diseases
- ClinicalTrials.gov ID
- NCT04352088
- Acronym / sponsor ID
- AKTL1
- Conditions
- Allergic Rhinitis, Allergic Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 17 Apr 2020 (actual)
- 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.
This study aims to investigate immune mechanisms and phenotypes and endotypes of allergic airway diseases - allergic rhinitis and allergic asthma. Pathogenesis of these diseases are not fully investigated yet. Patients with the same disease have different dominant symptoms, course of the disease and response to treatment. Moreover, there is a hypothesis about united airway disease suggesting that allergic rhinitis and allergic asthma is different manifestation of the same disease. This led to assumption of phenotypes and endotypes. This classification which still is not unified can let to prescribe personalized treatment for every patient.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Allergic rhinitis patients | – | Procedure: Nasal provocation test |
| Allergic rhinitis and asthma patients | – | Procedure: Nasal provocation test |
| Healthy individuals | – | Procedure: Nasal provocation test |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with allergic rhinitis with or without asthma and healthy individuals for control group.
Key inclusion criteria (2 listed)
- Hypersensitivity to house dust mites
- Allergic rhinitis with or without mild to moderate asthma
Key exclusion criteria (5 listed)
- Acute or chronic infections
- Use of systemic immunosupresants (wait 1 month)
- Use of systemic or local antihistamines (wait 1 week)
- Use of intranasal steroids (wait 1 month)
- Oncological or active autoimmune diseases
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 |
|---|---|---|
| Nasal provocation testAllergen extract under controlled conditions will be applied into nasal mucous. | Procedure or surgery | Allergic rhinitis and asthma patients, Allergic rhinitis patients, Healthy individuals |
Primary outcome
Cytokines level in nasal lavage and peripheral blood after nasal provocation test in different groups.
Time frame: 2 hours
Cytokines (IL-13, IL-10, IL-22, etc.) level will be measured by ELISA before and after nasal provocation test with house dust mites. Comparison between different groups.
Cytokines level in nasal lavage and peripheral blood after nasal provocation test in different groups.
Time frame: 22 hours
Cytokines (IL-13, IL-10, IL-22, etc.) level will be measured by ELISA before and after nasal provocation test with house dust mites.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Brigita Sitkauskiene contact
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 Allergic Rhinitis and Allergic Asthma, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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 5 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: status not confirmed, as of the sponsor's last update on 17 Apr 2020. 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 Lithuania. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Tamasauskiene, MD (+37061569127, lau.tamasauskiene@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokines level in nasal lavage and peripheral blood after nasal provocation test in different groups. (time frame: 2 hours). The study lists 2 primary outcomes in all. 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 17 Apr 2020.