Allergic RhinitisNCT01485523
Sensitivity and Specificity of Nasal Provocation Test in Allergic Rhinitis to House Dust Mites
An observational study of Allergic Rhinitis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The diagnosis of allergic rhinitis to dust mites is difficult and based on three elements : suggestive symptoms of clinical sensitization to dust mites (rhinitis), the existence of an IgE sensitization defined by skin tests and / or specific IgE positive to mite and finally the presence of mite allergens in the… 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
- What is being tested?
- Nasal provocation test
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Aug 2012
- 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: From the allergy clinic patients who have a rhinitis and positive skin test to mite or to other aeroallergens or negative skin test
Who may be able to join
- Non-smoking or smoking less than five cigarettes per day
- Subject affiliated with a social security system
- Informed consent signed and dated by the investigator and the subject
- Having been informed about the results of prior medical
Who cannot join
- Moderate to severe persistent asthma (FEV <70%)
- Treatment:
- H1 antihistamine (stop for less than 7 days) * Non-steroidal analgesics (stop for less than a week)* Central anti-hypertensive for 4 weeks- Corticosteroids: Nasal (stop for less than 7 days)Oral (if supported by more than 10 mg per day, stopping for less than a week)Intramuscular *Imipramine and other tricyclic treatment (stop for less than a week) *Ketotifen (stop for less than two weeks) *Leukotriene antagonists (stop for less than a week) * Nasal vasoconstrictors (one week)*
- Acute bacterial rhinosinusitis, systemic hypertension, myocardial infarction (<3 months), recent stroke (<3 months), known arterial aneurysm, epilepsy treatment, drug allergy
- Inability to measure a change in flow resistance and intra nasal (nasal obstruction complete)
- History of anaphylaxis to the allergen tested
Show all 12Show fewer
- Nasal surgery 6-8 weeks before the study
- Subject exclusion period (determined by a previous study or in progress)
- Unable to give informed about the information (subject in an emergency situation, difficulties in understanding the subject)
- Inability to understand the maneuvers of nasal provocation test
- Subject in safeguarding justice, under guardianship
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
France1 site
Pole de pathologie thoracique.Unité d'allergologie, d'asthmologie et de pathologie respiratoire de l'environnement
Strasbourg, France, 67000
About this study
The diagnosis of allergic rhinitis to dust mites is difficult and based on three elements : suggestive symptoms of clinical sensitization to dust mites (rhinitis), the existence of an IgE sensitization defined by skin tests and / or specific IgE positive to mite and finally the presence of mite allergens in the environment where the patient is symptomatic. Unfortunately, the link between symptoms and exposure to dust mites is rarely found and according to in the literature, 30% of rhinitis sensitized to house dust mites did not react during a conventional nasal provocation test (TPNC) to dust mites. Thus, TPNC to dust mite has an interest in the diagnosis of allergic rhinitis to dust mites when there remains a doubt due to the poly sensitization of the patient, or the lack of specific symptoms and / or the variability of the allergic symptoms during the year. However, this test has not been completely validated with a study including a significant number of patients. That's why the investigators plan a prospective single-center comparative open study with the main objective is to determine the sensitivity and specificity of conventional nasal provocation test (TPNC) in 120 patients of 18 to 65 years old with allergic rhinitis sensitized to dust mites and patients with allergic rhinitis not sensitized to dust mites. The investigators secondary objective is to compare the TPNC a faster TPN-called "minute" (60 minutes) and which allow a wider use. If the investigators demonstrate the validity of TPN then it would become the gold standard needed to decide on a desensitisation to mites.
- Conditions
- Allergic Rhinitis
- Being tested
- Nasal provocation test
- Keywords
- Allergic rhinitis, 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 testOther
Also called A patients with allergic rhinitis sensitized to dust mites, B control subjects with allergic rhinitis not sensitized to dust mites, C control subjects without allergic rhinitis
TPNC to dust mite has an interest in the diagnosis of allergic rhinitis to dust mites when there remains a doubt due to the poly sensitization of the patient, or the lack of specific symptoms and / or the variability of the allergic symptoms during the year. However, this test has not completely validated with a study including a significant number of patients. That's why we plan a prospective single-center comparative open study with the main objective is to determine the sensitivity and specificity of conventional nasal provocation test (TPNC) in 120 patients of 18 to 65 years old with allergic rhinitis sensitized to dust mites and patients with allergic rhinitis not sensitized to dust mites. Our secondary objective is to compare the TPNC a faster TPN-called "minute" (60 minutes) and which allow a wider use. If we demonstrate the validity of TPN then it would become the gold standard needed to decide on a desensitisation to mites.
| Study group | Role | What they receive |
|---|---|---|
| Patients | A = Patients with allergic rhinitis sensitized to dust mites Receives: Other: Nasal provocation test | |
| Control Subjects | B = control subjects with allergic rhinitis not sensitized to dust mites C = control subjects without allergic rhinitis Receives: Other: Nasal provocation test |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionAug 2012
- Study completionAug 2012
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 RhinitisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Jacques Braun, Principal investigator, Hôpitaux Universitaires de StrasbourgFrédéric De Blay, Study director, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485523
- Sponsor's protocol ID
- 5103
- Status last verified
- Mar 2013
- First submitted
- 1 Dec 2011
- Last updated
- 13 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
de Blay F, Doyen V, Lutz C, Godet J, Barnig C, Qi S, Braun JJ. A new, faster, and safe nasal provocation test method for diagnosing mite allergic rhinitis. Ann Allergy Asthma Immunol. 2015 Nov;115(5):385-390.e1. doi: 10.1016/j.anai.2015.07.014. Epub 2015 Aug 8.
PubMed 26265011
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity and Specificity of Nasal Provocation Test in Allergic Rhinitis to House Dust Mites
- ClinicalTrials.gov ID
- NCT01485523
- Acronym / sponsor ID
- 5103
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic rhinitis, Nasal provocation test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 5 Dec 2011 (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 diagnosis of allergic rhinitis to dust mites is difficult and based on three elements : suggestive symptoms of clinical sensitization to dust mites (rhinitis), the existence of an IgE sensitization defined by skin tests and / or specific IgE positive to mite and finally the presence of mite allergens in the environment where the patient is symptomatic. Unfortunately, the link between symptoms and exposure to dust mites is rarely found and according to in the literature, 30% of rhinitis sensitized to house dust mites did not react during a conventional nasal provocation test (TPNC) to dust mites. Thus, TPNC to dust mite has an interest in the diagnosis of allergic rhinitis to dust mites when there remains a doubt due to the poly sensitization of the patient, or the lack of specific symptoms and / or the variability of the allergic symptoms during the year. However, this test has not been completely validated with a study including a significant number of patients. That's why the investigators plan a prospective single-center comparative open study with the main objective is to determine the sensitivity and specificity of conventional nasal provocation test (TPNC) in 120 patients of 18 to 65 years old with allergic rhinitis sensitized to dust mites and patients with allergic rhinitis not sensitized to dust mites. The investigators secondary objective is to compare the TPNC a faster TPN-called "minute" (60 minutes) and which allow a wider use. If the investigators demonstrate the validity of TPN then it would become the gold standard needed to decide on a desensitisation to mites.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Nasal provocation testA = Patients with allergic rhinitis sensitized to dust mites |
| Control Subjects | – | Other: Nasal provocation testB = control subjects with allergic rhinitis not sensitized to dust mites C = control subjects without allergic rhinitis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- From the allergy clinic patients who have a rhinitis and positive skin test to mite or to other aeroallergens or negative skin test
Key inclusion criteria (4 listed)
- Non-smoking or smoking less than five cigarettes per day
- Subject affiliated with a social security system
- Informed consent signed and dated by the investigator and the subject
- Having been informed about the results of prior medical
Key exclusion criteria (12 listed)
- Moderate to severe persistent asthma (FEV <70%)
- Treatment:
- Acute bacterial rhinosinusitis, systemic hypertension, myocardial infarction (<3 months), recent stroke (<3 months), known arterial aneurysm, epilepsy treatment, drug allergy
- Inability to measure a change in flow resistance and intra nasal (nasal obstruction complete)
- History of anaphylaxis to the allergen tested
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 testAlso: A patients with allergic rhinitis sensitized to dust mites, B control subjects with allergic rhinitis not sensitized to dust mites, C control subjects without allergic rhinitisTPNC to dust mite has an interest in the diagnosis of allergic rhinitis to dust mites when there remains a doubt due to the poly sensitization of the patient, or the lack of specific symptoms and / or the variability of the allergic symptoms during the year. However, this test has not completely validated with a study including a significant number of patients. That's why we plan a prospective single-center comparative open study with the main objective is to determine the sensitivity and specificity of conventional nasal provocation test (TPNC) in 120 patients of 18 to 65 years old with allergic rhinitis sensitized to dust mites and patients with allergic rhinitis not sensitized to dust mites. Our secondary objective is to compare the TPNC a faster TPN-called "minute" (60 minutes) and which allow a wider use. If we demonstrate the validity of TPN then it would become the gold standard needed to decide on a desensitisation to mites. | Other | Control Subjects, Patients |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2013.
- Derived from this study: PubMed 26265011de Blay F, Doyen V, Lutz C, Godet J, Barnig C, Qi S, Braun JJ. A new, faster, and safe nasal provocation test method for diagnosing mite allergic rhinitis. Ann Allergy Asthma Immunol. 2015 Nov;115(5):385-390.e1. doi: 10.1016/j.anai.2015.07.014. Epub 2015 Aug 8.
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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.
Jean-Jacques Braun principal investigator
Hôpitaux Universitaires de Strasbourg
Frédéric De Blay study director
Hôpitaux Universitaires de Strasbourg
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, run by University Hospital, Strasbourg, France 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 4 inclusion and 12 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: finished, as of the sponsor's last update on 13 Mar 2013. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01485523, 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 13 Mar 2013.