CompletedNot Applicable

Kinetics of Nasal Cytokine Responses to Mechanical Stimulation

Austria30 participantsStarted 2021-03-25

Plain-language summary

IgE-associated allergy is a hypersensitivity disease affecting more than 40% of the population in industrialised countries. Recently the kinetics of change of clinical and immunological parameters (e.g. nasal blockage and cytokine profiles) in response to allergen exposure have been described. Additionally through recent placebo controlled studies it has become clear that the response of certain cytokines can not only be triggered by allergen exposure but also mechanically e.g through the insertion of nasal swabs for collection of cytokines. However it is not clear to what extent the mechanically triggered cytokine responses may differ between healthy, allergic and asthmatic patients who have been shown to have different cytokine profiles in their nasal secretions and varying impairment of their respiratory epithelium. As collection devices for nasal secretions are frequently used in clinical studies, the investigators aim to assess the impact of mechanical stimulation by frequent cytokine sampling on the cytokine profile.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: All groups * Male or female * 18 to 50 years of age * Willingness to comply with the study protocol and written informed consent * Subjects must have a standard health care insurance * Subjects must be available during the study period to complete all treatments and assessments Allergic Rhinitis * Moderate to severe allergic rhinitis to grass pollen for at least two seasons according to medical history * Skin prick test positive to grass pollen extract * Blood ImmunoCAP sensitisation to grass pollen (\>0.35 kU/L grass pollen extract specific IgE or higher as determined by UniCAP-FEIA) * No history of Asthma Allergic Asthma * Clinical history of asthma * Spirometry reversibility or PC20 methacholine/histamine \<8mg * Skin prick test positive to grass extract * Blood ImmunoCAP sensitisation to grass pollen (\>0.35 kU/L grass pollen extract specific IgE or higher as determined by UniCAP-FEIA) Non-Allergics * No history of Asthma * No history of allergy * Negative skin prick test to a common skin prick test panel including grass pollen * No ImmunoCAP sensitisation to to grass pollen (\<0.35 kU/L grass pollen extract specific IgE or higher as determined by UniCAP-FEIA) Exclusion Criteria: * Older than 50 or younger than 18 years * Active smoker * History of anaphylaxis * Any severe chronic, malignant or general disease * Treatment with systemic or topical (intranasal, inhaled, external) corticosteroids within the previous 2 months before the start of …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Nasal cytokine responses to repeated mechanical stimulation in allergics, non allergics and asthmatics.

Timeframe: 1 Year

Trial details

NCT IDNCT04878237

SponsorMedical University of Vienna

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05-31

View on ClinicalTrials.gov More Allergic Rhinitis Due to Grass Pollen trials