Allergic AsthmaSAIRANCT02214303
The Role of Th9 Cells and Eosinophils Activity in Allergic Airway Diseases
An observational study of Allergic Asthma and Allergic Rhinitis, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial summary
The prevalence of allergic diseases, especially airway allergic diseases, has increased dramatically over the last twenty years all over the world including Lithuania. Allergic diseases are associated with significantly reduced quality of life and can sometimes cause death. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Asthma, Allergic Rhinitis
- How many people
- 100 participants
- Where
- 1 siteLithuania
- Study dates
- Apr 2013to Dec 2015
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Allergic asthma
- Inclusion criteria:
- Men and women between the ages of 18-50 years;
- Allergic asthma (skin prick test positive for D. pteronyssinus, 5 grass mixture or birch pollen);
- Symptoms more than one year;
- Positive Bronchial challenge with methacholine or documented completely reversible bronchial obstruction;
- Stable lung function (FEV1≥70 perc.);
- Allergic rhinitis diagnosed according ARIA criteria.
- Postmenopausal women. Premenopausal women if pregnancy test is negative
- Healthy (subjects who are not sick with acute or chronic inflammatory, infectious, oncologic or immune diseases) - control group
- Participants who gave his/her informed written consent.
II. Exclusion criteria
- Asthma and rhinitis exacerbation;
- Clinically significant permanent allergy symptoms (ex. cat or dog dander induced allergy);
- Active airway infection 1 month prior the study;
- Used medicaments:
- Inhaled glucocorticoids intake 1 month prior the study;
- Antihistamines intake 7 days prior the study;
- Short acting β2 agonists 12 hours prior the study;
- Long acting β2 agonists 2 days prior the study;
- Leukotriene receptor antagonists prior 14 days;
- If the histamine mean wheal diameter is <= 3 mm or control mean wheal diameter is >= 3 mm;
- Psychiatric disorders;
- Alcohol or narcotic abuse;
- Pregnancy.
- Breast-feeding.
Trial locations and contacts
1 site in 1 country.
Lithuania1 site, 1 recruiting
- Recruiting
Lithuanian University of Health Sciences
Kaunas, 50009
Raimundas Sakalauskas, prof., dr., 37326953 ext. +370, raimundas.sakalauskas@kaunoklinikos.lt
Deimante Hoppenot, MD, 67439677 ext. +370, deimante@gmail.com
About this study
Official title: The Role of Th9 Cells Expression and Eosinophils Activity in the Course of Allergic Airway Diseases
The prevalence of allergic diseases, especially airway allergic diseases, has increased dramatically over the last twenty years all over the world including Lithuania. Allergic diseases are associated with significantly reduced quality of life and can sometimes cause death. Allergic diseases have turned into an important economic and social burden and nowadays take a more and more important place in the health system. Despite all intensive investigations, the pathogenesis of allergic airway diseases still remains unclear. As allergic diseases have a systemic pattern and multicomponent pathogenesis, it is important to investigate not individual cells, but examine various inflammatory cells instead, including their biological products and possible cellular interactions along the course of allergic diseases. This research focuses on the cells that are claimed to be important in the pathogenesis of allergic airway diseases, i.e. a newly found effector T helper cell subset (Th9 cells), which still lacks deeper investigation, and the main inflammatory cell, eosinophil. This study aims at determining the importance the way the Th9 lymphocytes perform, the eosinophil's activity, as well as molecular factors affecting these cells has in the process of prognostication of allergic airway diseases, namely allergic rhinitis and allergic asthma. An allergen challenge test will be performed in order to define the meaning of pathogenetic changes. The results of this research may reveal useful information in the course of allergic diseases and may be valuable when creating strategic principles of prophylaxis. The findings could be used for prevention and early diagnostics of allergic diseases and it could also open doors to discovering new and effective treatment.
- Conditions
- Allergic Asthma, Allergic Rhinitis
- Keywords
- Allergic asthma, Allergic rhinitis, Healthy subjects
- Medical subject headings
- Rhinitis, Allergic
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 |
|---|---|---|
| Allergic asthma | Allergic asthma (sensibilisation to D. pteronyssinus, 5 grass mixture allergens or birch pollen allergens) | |
| Allergic rhinitis | allergic rhinitis patients (sensibilisation to D. pteronyssinus, 5 grass mixture allergens or birch pollen allergens) | |
| Control group | Healthy subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Th9 cells and eosinophil apoptosis
Blood and sputum eosinophils also peripheral blood th9 cells will be investigated.
Measured: 24 hours after bronchial allergen challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startApr 2013
- Primary completionSep 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic 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
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raimundas Sakalauskas, Lithuanian University of Health Sciences
- Investigators
- Raimundas Sakalauskas, Prof., dr., Study chair, Lithuanian University of Health Sciences, Pulmonology and Immunology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214303
- Sponsor's protocol ID
- SAIRA-1017/2012
- Acronym
- SAIRA
- Status last verified
- Aug 2014
- First submitted
- 6 Aug 2014
- Last updated
- 12 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hoppenot D, Malakauskas K, Lavinskiene S, Sakalauskas R. p-STAT6, PU.1, and NF-kappaB are involved in allergen-induced late-phase airway inflammation in asthma patients. BMC Pulm Med. 2015 Oct 14;15:122. doi: 10.1186/s12890-015-0119-7.
PubMed 26466682
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Th9 Cells Expression and Eosinophils Activity in the Course of Allergic Airway Diseases
- ClinicalTrials.gov ID
- NCT02214303
- Acronym / sponsor ID
- SAIRA / SAIRA-1017/2012
- Conditions
- Allergic Asthma, Allergic Rhinitis
- Keywords
- Allergic asthma, Allergic rhinitis, Healthy subjects
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 12 Aug 2014 (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 prevalence of allergic diseases, especially airway allergic diseases, has increased dramatically over the last twenty years all over the world including Lithuania. Allergic diseases are associated with significantly reduced quality of life and can sometimes cause death. Allergic diseases have turned into an important economic and social burden and nowadays take a more and more important place in the health system. Despite all intensive investigations, the pathogenesis of allergic airway diseases still remains unclear. As allergic diseases have a systemic pattern and multicomponent pathogenesis, it is important to investigate not individual cells, but examine various inflammatory cells instead, including their biological products and possible cellular interactions along the course of allergic diseases. This research focuses on the cells that are claimed to be important in the pathogenesis of allergic airway diseases, i.e. a newly found effector T helper cell subset (Th9 cells), which still lacks deeper investigation, and the main inflammatory cell, eosinophil. This study aims at determining the importance the way the Th9 lymphocytes perform, the eosinophil's activity, as well as molecular factors affecting these cells has in the process of prognostication of allergic airway diseases, namely allergic rhinitis and allergic asthma. An allergen challenge test will be performed in order to define the meaning of pathogenetic changes. The results of this research may reveal useful information in the course of allergic diseases and may be valuable when creating strategic principles of prophylaxis. The findings could be used for prevention and early diagnostics of allergic diseases and it could also open doors to discovering new and effective treatment.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Allergic asthma | – | –Allergic asthma (sensibilisation to D. pteronyssinus, 5 grass mixture allergens or birch pollen allergens) |
| Allergic rhinitis | – | –allergic rhinitis patients (sensibilisation to D. pteronyssinus, 5 grass mixture allergens or birch pollen allergens) |
| Control group | – | –Healthy subjects |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Allergic 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
Th9 cells and eosinophil apoptosis
Time frame: 24 hours after bronchial allergen challenge
Blood and sputum eosinophils also peripheral blood th9 cells will be investigated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2014.
- Derived from this study: PubMed 26466682Hoppenot D, Malakauskas K, Lavinskiene S, Sakalauskas R. p-STAT6, PU.1, and NF-kappaB are involved in allergen-induced late-phase airway inflammation in asthma patients. BMC Pulm Med. 2015 Oct 14;15:122. doi: 10.1186/s12890-015-0119-7.
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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.
Raimundas Sakalauskas, Prof., dr. study chair
Lithuanian University of Health Sciences, Pulmonology and Immunology department
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 Asthma and Allergic Rhinitis, 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?
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 12 Aug 2014. 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 Raimundas Sakalauskas, prof., dr. (376953 ext. +370, raimundas.sakalauskas@kaunoklinikos.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Th9 cells and eosinophil apoptosis (time frame: 24 hours after bronchial allergen challenge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02214303, which also lists 1 linked publication.
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 12 Aug 2014.