Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05621356
Other study ID # 2021-1924
Secondary ID NL78278.091.21
Status Recruiting
Phase
First received
Last updated
Start date October 25, 2022
Est. completion date March 31, 2023

Study information

Verified date November 2022
Source Rijnstate Hospital
Contact Janneke Ruinemans-Koerts
Phone 0031 88 005 8888
Email j.ruinemans-koerts@rijnstate.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Allergic rhinitis (hay fever) can be treated successfully with allergen-specific immunotherapy (AIT) for 3-5 years. This relative expensive and prolonged treatment is not suitable for everyone and therefore it is important to predict who will benefit from this therapy early after the start of treatment. This project will investigate whether a BAT with nasal fluid can detect inhibition during immunotherapy in comparison with a BAT with blood.


Description:

Allergic rhinitis (hay fever) can be treated successfully with allergen-specific immunotherapy (AIT) for 3-5 years. This relative expensive and prolonged treatment is not suitable for everyone and therefore it is important to predict who will benefit from this therapy early after the start of treatment. Biomarkers, like Basophil Activation Test (BAT) and IgE-facilitated allergen binding (FAB), using nasal fluid instead of blood, probably better reflect therapy effect (inhibition of an IgE-mediated allergic reaction) as the nose is the main target organ for AIT in allergic rhinitis. This project will investigate whether a BAT with nasal fluid can detect inhibition during immunotherapy in comparison with a BAT with blood. Nasal fluid and blood samples are collected at baseline and after 8 and 16 weeks of treatment. A nasal fluid inhibition BAT is developed and validated by comparison with a BAT using serum and an IgE-FAB assay. 15 adults with birch pollen allergy, who are treated with AIT (Itulazax birch pollen tablet) and 10 adults with birch pollen allergy, who are treated with immunosuppressive medication (control group) will be included in the study.


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date March 31, 2023
Est. primary completion date December 23, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - IgE-sensitized birch pollen allergy - Start of Itulazax therapy or immunosuppressive therapy (nasal corticosteroid and/or antihistamine eye drops) - Signed informed consent Exclusion Criteria: - Other underlying chronic conditions (immunological (autoimmune or immunodeficiency), oncological) - Unstable uncontrolled asthma - Smoking

Study Design


Intervention

Other:
A nasal fluid Basophil Activation Test (BAT)
a BAT technique for monitoring the inhibitory effect of nasal fluid on basophil activation.

Locations

Country Name City State
Netherlands Rijnstate Hospital Arnhem

Sponsors (2)

Lead Sponsor Collaborator
Rijnstate Hospital Wageningen University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary BAT outcome nasal fluid 8 weeks
Primary BAT outcome nasal fluid 16 weeks
Primary BAT outcome serum 8 weeks
Primary BAT outcome serum 16 weeks
Secondary IgG4/IgA-associated inhibitory activity in nasal fluid 8 weeks
Secondary IgG4/IgA-associated inhibitory activity in nasal fluid 16 weeks
Secondary IgG4/IgA-associated inhibitory activity in serum 8 weeks
Secondary IgG4/IgA-associated inhibitory activity in serum 16 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05848011 - A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer Phase 2
Recruiting NCT05161572 - Perioperative Chemoimmunotherapy With/Without Preoperative Chemoradiation for Locally Advanced Gastric Cancer Phase 2
Recruiting NCT06165900 - Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of TNBC Phase 2
Recruiting NCT06120127 - Postoperative Chemotherapy With/Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence Phase 2
Recruiting NCT06262581 - Neoadjuvant Tisleizumab(BGB-A317) for dMMR/MSI-H Non-late Stage CRC Patients Before Surgery Phase 2
Recruiting NCT05176002 - Camrelizumab in Combination With Radiotherapy for Neoadjuvant Esophageal Carcinoma. Phase 1/Phase 2
Not yet recruiting NCT05909137 - Omitting Clinical Target Volume in Radical Treatment of Unresectable Stage III Non-small Cell Lung Cancer
Recruiting NCT04500990 - MRI DWI None-Gaussian Model Predicting Early Response to Immunotherapy in Digestive System Malignancies: a Prospective Observational Study
Not yet recruiting NCT04372732 - Serum Autoantibodies in Predicting the Efficacy of Anti-PD-1 Treatment in Patients With Advanced NSCLC
Completed NCT02692976 - Natural Dendritic Cells for Immunotherapy of Chemo-naive Metastatic Castration-resistant Prostate Cancer Patients Phase 2
Completed NCT03763630 - MAPS & ITEC Cohorts: 6-8 Years Follow-up Phase 2
Not yet recruiting NCT06012318 - Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING)
Not yet recruiting NCT05479240 - Neoadjuvant Chemoradiotherapy Combined With Tislelizumab in the Treatment of Locally Advanced Rectal Cancer Phase 2
Recruiting NCT05515796 - Multi-omics Sequencing in Neoadjuvant Immunotherapy of Gastrointestinal Tumors Phase 2
Recruiting NCT04711330 - Response and Toxicity Prediction by Microbiome Analysis After Concurrent Chemoradiotherapy
Recruiting NCT03701607 - Effect of Chemotherapy on PD-L1 in NSCLC
Recruiting NCT03683407 - Effect of Chemotherapy on TMB in NSCLC
Completed NCT03357861 - Cancer Patients Treated With Immunotherapy in Intensive Care Unit
Recruiting NCT05223088 - Tislelizumab Combined With Apatinib and Oxaliplatin Plus S1 as Neoadjuvant Therapy for Borrmann IV、Large Borrmann III Type and Bulky N Positive Advanced Gastric Cancer Phase 2
Completed NCT05657262 - Effect of Z Technıque on Pain, Comfort, Symptoms in Ummunotherapy Areas N/A