Mite AllergyPhase 4NPT-MARNCT04915352
Interest of Nasal Provocation Tests for Diagnosis of House Mites Allergic Rhinitis
A Phase 4 study testing Nasal provocation test - 725 Dermatophagoides Pteronyssinus in people with Mite Allergy and Respiratory Disease, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mite Allergy, Respiratory Disease
- What is being tested?
- Nasal provocation test - 725 Dermatophagoides Pteronyssinus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 7 Mar 2022to 5 Jul 2024
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Allergic rhinitis due to house dust mites (AAR) is a common condition which impairs the quality of life of patients and which can be responsible for complications such as the development of asthma. The only curative treatment available is allergenic immunotherapy (ITA).
Currently, the diagnostic approach is based on the history, which collects the symptoms reported by patients during a possible allergen exposure and on the results of skin tests (CT) and / or specific IgE assays (IgEs), which confirm biological sensitization.
In a recent retrospective study, the positive predictive value of TCs and IgEs is estimated at 77% for D. pteronyssinus and 69% for D. farinae. Approximately 30% of patients who have TCs and / or IgEs directed against mites therefore only have biological sensitization.
The nasal challenge test (NPT) has been shown to be an effective tool in improving the diagnosis of dust mite allergic rhinitis. The RNTP is easy to perform, consisting of the nasal spraying of 3 solutions of increasing concentrations (50; 500 and 5000 SBE / ml). RNTP demonstrated good sensitivity and specificity (83.7% and 100%) as well as identical safety in use compared to "classic" TPN. But its real impact on the diagnostic and above all therapeutic strategy has not yet been assessed.
The hypothesis is that RNTP has a positive predictive value superior to TC and IgEs for the diagnosis of allergic rhinitis to dust mites and therefore for the efficacy of ITA.
To demonstrate this, the investigators propose to compare the diagnostic values of these 3 tests, taking the efficacy of ITA at 1 year as the gold standard. The expected results are better predictive values for RNTP, and therefore the possibility of avoiding unnecessary treatments for the patients concerned. About 30% of patients could be treated wrongly now, with the use of TCs and IgEs alone.
- Conditions
- Mite Allergy, Respiratory Disease
- Being tested
- Nasal provocation test - 725 Dermatophagoides Pteronyssinus, Negative control
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal provocation test - 725 Dermatophagoides PteronyssinusDrug
Also called Dermatophagoides Pteronyssinus
3 different concentrations of Nasal Provocation Test are administered to patients:
- Nasal spray at 50 SBE/ml for 36 months
- Nasal spray at 500 SBE/ml for 36 months
- Nasal spray at 5000 SBE/ml for 36 months
Negative controlOther
Negative control using only solvent is applied in order to consider a non-specific nasal hyper reactivity.
| Study group | Role | What they receive |
|---|---|---|
| Adult dust mite allergenic rhinitis patients | Experimental | Nasal Provocation Test administration (725 Dermatophagoides pteronyssinus (5.000 SBE/ml) dosage form: Lyophilisate and solvent for nasal drops, suspension dosage and frequency: 3 nasal sprays at 3 different concentrations per year: 50, 500 and 5000 SBE / ml for 3 years Duration: 36 months Receives: Drug: Nasal provocation test - 725 Dermatophagoides Pteronyssinus; Other: Negative control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The negative predictive value calculated with the efficacy of ITA at 1 year
The primary endpoint is negative predictive value, calculated with the efficacy of ITA at 1 year as the gold standard. It corresponds to the number of patients for whom treatment with an ITA will have been effective at 1 year, divided by the number of patients who have received an ITA.
It will be calculated on the one hand for patients with TC and / or IgEs positive (control strategy), and on the other hand for patients with TC and / or IgEs positive and RNTP positive.
Measured: Year 1
Secondary outcomes (5)
Efficacity of ITA at 2 and 3 years, according to the same methods as for the primary endpoint.
The efficacity of ITA at 2nd and 3rd year corresponds to the number of patients for whom treatment with an ITA will have been effective, divided by the number of patients who have received an ITA.
It will be calculated on the one hand for patients with TC and / or IgEs positive (control strategy), and on the other hand for patients with TC and / or IgEs positive and RNTP positive.
Measured: Years 2 and 3
Negative predictive value of the TC + IgEs + RNTP strategy for the efficacy of ITA at 1, 2 and 3 years, according to the same methods as for the primary endpoint.
The negative predictive value of ITA at 2nd and 3rd year corresponds to the number of patients for whom treatment with an ITA will have been effective, divided by the number of patients who have received an ITA.
It will be calculated on the one hand for patients with TC and / or IgEs positive (control strategy), and on the other hand for patients with TC and / or IgEs positive and RNTP positive.
Measured: Years 1, 2 and 3
Evaluation of the symptoms of allergic rhinitis using the CSMS score at 1, 2 and 3 years
cSMS: Combined Symptom and Medication Score The European Academy of Allergy and Clinical Immunology published a consensus related to the combination of symptom and medication scores (MSs). The total daily medication score (dMS) ranges from 0 to 3. The CSMS is the sum of total daily symptom score (dSS:range 0-3) and total daily medication score (dMS: range 0-3). Therefore, the values of CSMS are in the range of 0-6 (minmum-maximum).
Measured: Years 1, 2 and 3
Assessment of symptoms of allergic rhinitis using Lebel score at 1, 2 and 3 years
Lebel Bousquet score The RNTP was positive if the (Lebel Bousquet score) was greater than 5/13 points, 13/13 being the worse score
Measured: Years 1, 2 and 3
Evaluation of the specific quality of life at 1, 2 and 3 years, using the RQLQ questionnaire.
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) The RQLQ is a self-administered questionnaire that contains 28 questions in 7 domains: activities limitation (3 questions), sleep problems (3 questions), nose symptoms (4 questions), eye symptoms (4 questions), non-nose or eye symptoms (7 questions), practical problems (3 questions), and emotional function (4 questions). Scores for each question range from 0 (not troubled/none of the time) to 6 (extremely troubled/all of the time). The overall RQLQ score is the mean of all 28 responses, and the individual domain scores are the means of the questions in each domain - both range from 0 to 6.
Measured: Years 1, 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start7 Mar 2022
- Primary completion5 Jul 2024
- Study completion5 Jul 2024
Why it stopped: The study is terminated because the product (nasal provocation test) is out of stock.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mite AllergyStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Strasbourg, France, Centre Hospitalier de Verdun, CHU de Reims
- Responsible party
- Sponsor
- Investigators
- Sébastien LEFEVRE, MD, Principal investigator, CHR Metz Thionville Hopital de Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915352
- Sponsor's protocol ID
- 2018-000597-29
- Other IDs
- 2018
- Acronym
- NPT-MAR
- Status last verified
- Aug 2024
- First submitted
- 21 May 2021
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Nasal Provocation Tests for Diagnosis of House Mites Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT04915352
- Acronym / sponsor ID
- NPT-MAR / 2018-000597-29
- Conditions
- Mite Allergy, Respiratory Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study is terminated because the product (nasal provocation test) is out of stock.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Collaborators
- University Hospital, Strasbourg, France, Centre Hospitalier de Verdun, CHU de Reims
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 5 Jul 2024 (actual)
- Study completion
- 5 Jul 2024 (actual)
- First posted
- 7 Jun 2021 (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.
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.
Detailed description
Allergic rhinitis due to house dust mites (AAR) is a common condition which impairs the quality of life of patients and which can be responsible for complications such as the development of asthma. The only curative treatment available is allergenic immunotherapy (ITA).
Currently, the diagnostic approach is based on the history, which collects the symptoms reported by patients during a possible allergen exposure and on the results of skin tests (CT) and / or specific IgE assays (IgEs), which confirm biological sensitization.
In a recent retrospective study, the positive predictive value of TCs and IgEs is estimated at 77% for D. pteronyssinus and 69% for D. farinae. Approximately 30% of patients who have TCs and / or IgEs directed against mites therefore only have biological sensitization.
The nasal challenge test (NPT) has been shown to be an effective tool in improving the diagnosis of dust mite allergic rhinitis. The RNTP is easy to perform, consisting of the nasal spraying of 3 solutions of increasing concentrations (50; 500 and 5000 SBE / ml). RNTP demonstrated good sensitivity and specificity (83.7% and 100%) as well as identical safety in use compared to "classic" TPN. But its real impact on the diagnostic and above all therapeutic strategy has not yet been assessed.
The hypothesis is that RNTP has a positive predictive value superior to TC and IgEs for the diagnosis of allergic rhinitis to dust mites and therefore for the efficacy of ITA.
To demonstrate this, the investigators propose to compare the diagnostic values of these 3 tests, taking the efficacy of ITA at 1 year as the gold standard. The expected results are better predictive values for RNTP, and therefore the possibility of avoiding unnecessary treatments for the patients concerned. About 30% of patients could be treated wrongly now, with the use of TCs and IgEs alone.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult dust mite allergenic rhinitis patients | Experimental | Drug: Nasal provocation test - 725 Dermatophagoides Pteronyssinus, Other: Negative controlNasal Provocation Test administration (725 Dermatophagoides pteronyssinus (5.000 SBE/ml) dosage form: Lyophilisate and solvent for nasal drops, suspension dosage and frequency: 3 nasal sprays at 3 different concentrations per year: 50, 500 and 5000 SBE / ml for 3 years Duration: 36 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (21 listed)
- 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
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 test - 725 Dermatophagoides PteronyssinusAlso: Dermatophagoides Pteronyssinus3 different concentrations of Nasal Provocation Test are administered to patients: * Nasal spray at 50 SBE/ml for 36 months * Nasal spray at 500 SBE/ml for 36 months * Nasal spray at 5000 SBE/ml for 36 months | Drug | Adult dust mite allergenic rhinitis patients |
| Negative controlNegative control using only solvent is applied in order to consider a non-specific nasal hyper reactivity. | Other | Adult dust mite allergenic rhinitis patients |
Primary outcome
The negative predictive value calculated with the efficacy of ITA at 1 year
Time frame: Year 1
The primary endpoint is negative predictive value, calculated with the efficacy of ITA at 1 year as the gold standard. It corresponds to the number of patients for whom treatment with an ITA will have been effective at 1 year, divided by the number of patients who have received an ITA. It will be calculated on the one hand for patients with TC and / or IgEs positive (control strategy), and on the other hand for patients with TC and / or IgEs positive and RNTP positive.
5 secondary outcomes
Efficacity of ITA at 2 and 3 years, according to the same methods as for the primary endpoint.
Time frame: Years 2 and 3
Negative predictive value of the TC + IgEs + RNTP strategy for the efficacy of ITA at 1, 2 and 3 years, according to the same methods as for the primary endpoint.
Time frame: Years 1, 2 and 3
Evaluation of the symptoms of allergic rhinitis using the CSMS score at 1, 2 and 3 years
Time frame: Years 1, 2 and 3
Assessment of symptoms of allergic rhinitis using Lebel score at 1, 2 and 3 years
Time frame: Years 1, 2 and 3
Evaluation of the specific quality of life at 1, 2 and 3 years, using the RQLQ questionnaire.
Time frame: Years 1, 2 and 3
Results and safety
The study was stopped early (reason given: The study is terminated because the product (nasal provocation test) is out of stock.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- 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.
Sébastien LEFEVRE, MD principal investigator
CHR Metz Thionville Hopital de Mercy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nasal provocation test - 725 Dermatophagoides Pteronyssinus in people with Mite Allergy and Respiratory Disease, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
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 3 inclusion and 21 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: stopped early, as of the sponsor's last update on 9 Aug 2024. 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 France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study is terminated because the product (nasal provocation test) is out of stock.). Results are not available in the source record.
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.
What does the primary outcome measure?
The negative predictive value calculated with the efficacy of ITA at 1 year (time frame: Year 1). 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 9 Aug 2024.