Interest of Nasal Provocation Tests for Diagnosis of House Mites Allergic Rhinitis (NCT04915352) | Clinical Trial Compass
TerminatedPhase 4
Interest of Nasal Provocation Tests for Diagnosis of House Mites Allergic Rhinitis
Stopped: The study is terminated because the product (nasal provocation test) is out of stock.
France8 participantsStarted 2022-03-07
Plain-language summary
The aim of this clinical trial is to compare the positive predictive value of the combination rapid nasal provocation test (RNTP) + skin tests (TC) + specific immunoglobulins E (IgEs) to the combination of TC + IgEs (strategy currently used in clinical practice) concerning the efficacy of treatment with Allergen immunotherapy (ITA) at 1 year, in patients with symptoms suggesting allergic rhinitis to house dust mites.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient over 18 years old,
* Patient with persistent mild to severe or moderate to severe intermittent rhinitis according to ARIA criteria, suspicion of allergic rhinitis to dust mites, and a positive skin test for mites and / or a positive mite specific IgE assay
* Patient having signed a free and informed consent
Exclusion Criteria:
* Pregnant or breastfeeding women
* Patients under guardianship or curatorship
* Patients under legal protection
* Patients not affiliated to a social security scheme
* Contraindications to performing a RNPT
* Active ENT or respiratory infections.
* Allergy in acute phase
* History of anaphylaxis due to the allergen involved.
* Unstabilized asthma and other obstructive pathologies.
* Severe general illnesses in evolution.
* Hypersensitivity to one of the components of the product
* Simultaneous treatment with beta-blockers or angiotensin-converting enzyme (ACE) inhibitors,
* Presence of an excessive degree of sensitization (e.g. history, excessive skin reactions),
* Contraindications to immunotherapy:
* Asthma (uncontrolled) or severe \[FEV \< 70% of the theorical value (after appropriate drug treatment) at the beginning of the treatment\].
* Severe asthma exacerbation in the last 3 months
* Active autoimmune diseases
* Malignant tumors
* Pregnancy (initiation of venereal disease)
* AIDS
* Treatment with beta-blockers, including eye drops
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
1
The negative predictive value calculated with the efficacy of ITA at 1 year