Sensitivity and Specificity of Nasal Provocation Test in Allergic Rhinitis to House Dust Mites

NCT ID: NCT01485523

Last Updated: 2013-03-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-08-31

Brief 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 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

A = Patients with allergic rhinitis sensitized to dust mites

Nasal provocation test

Intervention Type: OTHER

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.

Control Subjects

B = control subjects with allergic rhinitis not sensitized to dust mites C = control subjects without allergic rhinitis

Nasal provocation test

Intervention Type: OTHER

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.

Interventions

Nasal provocation test

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.

Intervention Type: OTHER

Other Intervention Names

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

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Jacques Braun

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires de Strasbourg

Frédéric De Blay

Role: STUDY_DIRECTOR

Hôpitaux Universitaires de Strasbourg

Locations

Pole de pathologie thoracique.Unité d'allergologie, d'asthmologie et de pathologie respiratoire de l'environnement

Strasbourg, France, France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 26265011 (View on PubMed)

Other Identifiers

5103

Identifier Type: -

Identifier Source: org_study_id