Clinical performance study of specific IgE test of house dust mite allergen components

Clinical performance study of specific IgE test of house dust mite allergen components - Clinical performance study of specific IgE test of house dust mite allergen components

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000035473

Enrollment

150

Registered

2019-03-01

Start date

2019-03-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Allergic rhinitis

Interventions

Stop anti-allergic medication for 3 days before nasal provocation test.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Allergic rhinitis patients with positive specific IgE of house dust mite and be able to receive nasal provocation test - Allergic rhinitis patients with negative specific IgE of house dust mite with no clinical history of house dust mite allergy

Exclusion criteria

Exclusion criteria: - Severe bronchial asthma or sever atopic dermatitis - Allergic rhinitis possibly caused by dog, cat, cockroach or moth - Specific IgE level of dog, cat, cockroach or moth is higher than house dust mite or higher than 10UA/mL - Received allergen-specific immunotherapy of house dust or house dust mite - Medicated with inhaled corticosteroids within 3 months before blood collection - Received anti-human IgE antibody therapy

Design outcomes

Primary

Measure	Time frame
To evaluate clinical sensitivity, clinical specificity, positive predictive value and negative predictive value of house dust mite allergen component-specific IgE test and compare with those of crude allergen extract-specific IgE test	—

Secondary

Measure	Time frame
- Distribution of the specific IgE levels - ROC analysis and estimate sensitivity, specificity, predictive values with the optimal cutoff - Assessment of relationship of specific IgE levels and nasal provocation outcome - 95% positive predictive value of the specific IgE test	—

Countries

Japan

Contacts

Public ContactSyuji Yonekura

Graduate School of Medicine, Chiba University Department of Otorhinolaryngology

syonekura@faculty.chiba-u.jp043-222-7171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026