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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01485523
First received: December 1, 2011
Last updated: March 12, 2013
Last verified: March 2013

December 1, 2011
March 12, 2013
January 2012
August 2012   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT01485523 on ClinicalTrials.gov Archive Site
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Sensitivity and Specificity of Nasal Provocation Test in Allergic Rhinitis to House Dust Mites
Sensitivity and Specificity of Nasal Provocation Test in Allergic Rhinitis to House Dust Mites

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Blood sample

Probability Sample

From the allergy clinic patients who have a rhinitis and positive skin test to mite or to other aeroallergens or negative skin test

Allergic Rhinitis
Other: 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.
Other 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
  • Patients
    A = Patients with allergic rhinitis sensitized to dust mites
    Intervention: Other: Nasal provocation test
  • Control Subjects
    B = control subjects with allergic rhinitis not sensitized to dust mites C = control subjects without allergic rhinitis
    Intervention: Other: Nasal provocation test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01485523
5103
No
University Hospital, Strasbourg, France
University Hospital, Strasbourg, France
Not Provided
Principal Investigator: Jean-Jacques Braun Hôpitaux universitaires de Strasbourg
Study Director: Frédéric De Blay Hôpitaux universitaires de Strasbourg
University Hospital, Strasbourg, France
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP