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

ConditionAllergic Rhinoconjunctivitis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorWroclaw Medical University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent given from patient according to local requirements before any trial-related activities started (a trial-related activity is any procedure that would not have been performed during the routine management of the patient)

Legally competent male or female outpatient between 18 and ≤ 65 years

IgE-mediated moderate to severe allergic rhinitis or rhinoconjunctivitis with or without allergic asthma caused by HDM allergens documented by

Symptoms of rhinitis or rhinoconjunctivitis e.g., during the months October to February or over the entire year for at least 2 years before enrolment.

Disqualifiers

Patients are unable to understand and comply with the requirements of the trial, as judged by the investigator

Currently participating in another clinical trial or participating in any other clinical trial within 30 days prior informed consent for this trial

Low adherence to trial procedures expected or inability to understand instructions/trial documents

Involvement in the planning and conduct of the trial

Trial design

Design model

Parallel

Treatments tested in this trial

  • NovoHelisen Depot

    Biological/Vaccine

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

Treatment groups

67 Participants
are divided into 2 treatment groups
Group A: verumActive comparator 1 intervention
Group B: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total nasal symptom score

The primary efficacy analysis is the analysis of correlation between TNSS recorded in the AEC and the average CSMS over 2 weeks as recorded in the eDiary.

Time frame
12 months

Secondary outcomes

1

Change of the TNSS

Change of the TNSS at 120 minutes recorded in the AEC from pre-treatment to post treatment, calculated as post treatment TNSS - pre-treatment TNSS, and Change in average CSMS from pre-treatment to post-treatment calculated as post treatment CSMS - pre-treatment CSMS

Time frame
12 months
2

Change in average CSMS

Change in average CSMS from pre-treatment to post-treatment calculated as post treatment CSMS - pre-treatment CSMS

Time frame
12 months

Other outcomes

Sponsors and contacts

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Wroclaw Medical University

Lead sponsor

ALL-MED Medical Research Institute, Wroclaw, Poland

Collaborator

Allergopharma GmbH & Co. KG

Collaborator

Source ClinicalTrials.gov
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