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Study on the Positive Diagnostic Criteria of Nasal Allergen Challenge

Study on the Positive Diagnostic Criteria of Nasal Allergen Challenge

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300079215
Enrollment
Unknown
Registered
2023-12-27
Start date
2021-12-01
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic rhinitis

Interventions

Gold Standard:Combined diagnostic methods: with typical allergic rhinitis symptoms, the following symptoms appear or worsen after exposure to dust mites: profuse discharge, paroxysmal sneezing, nasal
Skin prick test dust mite = (DP+++), serum dust mite-specific IgE = grade 3.
Index test:Nasal allergy challenge

Sponsors

Sichuan University West China Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 58 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria for the AR group: (1) age= 18 years old, gender is not limited; (2) According to the 2022 Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis, the patient has two or more symptoms of runny nose, nasal congestion, nasal itching, and sneezing, and the above symptoms persist continuously or cumulatively for more than 1 hour every day, or/and are accompanied by eye symptoms such as itching, redness, and tearing; Specialist examination reveals nasal mucosal pallor, edema, and watery discharge; (3) AR symptoms induced or aggravated by exposure to dust mites, such as patting bedding, exposure to long-term vacant houses, changing pillowcases, quilt covers, bed sheets, cleaning, etc.; (4) AR course of more than 1 year, with/without asthma; (5) SPT detection of Dp or Df =+++, and other allergens (including cat hair, dog hair, Alternaria alternaria, branchospores, juniperus, sycamore, birch, arboid, humulus, Artemisia macroseed, Artemisia annua) were negative SPT, and serum sIgE was detected with Dp or Df grade 3 or above. 2. Inclusion criteria for the NAR group: (1) Age= 18 years old, gender is not limited; (2) The patient has 2 or more symptoms of runny nose, nasal congestion, nasal itching and sneezing, and the above symptoms exist continuously or cumulatively for more than 1 hour every day, or/and are accompanied by eye symptoms such as itching, redness, and tearing; Symptoms may worsen with exposure to cold air; (3) All allergens described above are negative for SPT, and serum Df and sIgE tests are negative. 3. Inclusion criteria for the control group: (1) Age= 18 years old, gender is not limited; (2) No history of rhinitis, and there will be no symptoms such as runny nose, sneezing, nasal congestion, nasal itching, and itchy eyes when exposed to various external stimuli in life; (3) All allergens described above are negative for SPT, and serum Df and sIgE tests are negative.

Exclusion criteria

Exclusion criteria: (1) Age< 18 years old; (2) Suffering from other nasal diseases, such as infectious rhinitis, chronic atrophic rhinitis, vascular motor rhinitis, chronic sinusitis, nasal polyps, severe nasal septum deviation, nasal septal perforation, nasal tumors, etc. (3) Patients with uncontrolled asthma or severe chronic obstructive pulmonary disease or cardiopulmonary disease with contraindication of epinephrine; (4) Pregnancy.

Design outcomes

Primary

MeasureTime frame
Active anterior rhinomanometry, AAR;4-Phase-Rhinomanometry,4PR;Acoustic rhinometry, AcRh;Sensitivity, specificity, false positive rate, false negative rate, positive predictive value, negative predictive value;Lebel score;Linder score;TNSS score;VAS score;

Secondary

MeasureTime frame
sIgE;Tryptase;ECP;Area under curve (AUC) ;ROC curves;Correlation;Fitting analysis;

Countries

China

Contacts

Public ContactJuan Meng

Sichuan University West China Hospital

mjmelinda@163.com+86 189 8060 6505

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026