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

NCT01485523 | Completed

• 1 other identifier: 5103
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

Allergic rhinitis; Nasal provocation test

Study Arms (2)

Patients

A = Patients with allergic rhinitis sensitized to dust mites

Other: Nasal provocation test

Control Subjects

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

Other: Nasal provocation test

Interventions

Nasal provocation test 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.

Also known as: 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

Control Subjects; Patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

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

Strasbourg, France, 67000, France

Location

Related Publications (1)

• 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.

  PMID: 26265011 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Interleukin-13

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Jean-Jacques Braun

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

• Frédéric De Blay

  Hôpitaux Universitaires de Strasbourg

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2011
• First Posted: December 5, 2011
• Study Start: January 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: March 13, 2013

Record last verified: 2013-03

Locations

FR (1)