MedTrace Logo

Evaluation of the Efficacy of Allergen-specific Immunotherapy Using Assessment in an Allergen Exposure chamber-a Randomized Placebo-controlled Double-blind Study

NCT06778213 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2025-01-28

No results posted yet for this study

Summary

The main objective of the study is to measure and correlate clinical parameters suitable for the assessment of allergen immunotherapy (AIT) with an aluminum hydroxide-adsorbed preparation of house dust mite (Dermatophagoides pteronyssinus/ Dermatophagoides farinae) allergens in adults with moderate to severe allergic rhinitis/rhinoconjunctivitis with or without controlled allergic bronchial asthma caused by house dust mite (HDM) allergens. The assessment of clinical responses will be evaluated following an allergen challenge in allergen exposure chamber (AEC) before and during the course of AIT. Patients' response to therapy will be evaluated as well as in the AEC and by patient's personal environment (Diary).

Conditions

  • Allergic Rhinoconjunctivitis

Interventions

BIOLOGICAL

NovoHelisen Depot

allergen immunotherapy treatment for 12 months with house dust mite allergen preparation

Sponsors & Collaborators

  • ALL-MED Medical Research Institute, Wroclaw, Poland

    collaborator UNKNOWN

  • Allergopharma GmbH & Co. KG

    collaborator INDUSTRY

  • Wroclaw Medical University

    lead OTHER

Principal Investigators

  • Agnieszka M Chuda, MSc · ALL-MED Specjalistyczna Opieka Medyczna. Medyczny Instytut Badawczy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-02
Primary Completion
2026-04-02
Completion
2026-12-01

Countries

  • Poland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06778213 on ClinicalTrials.gov