Retrospective Study Evaluating the Effectiveness and Safety of Immunotherapy With Clustoid Max Forte

February 16, 2026 updated by: Inmunotek S.L.

Retrospective Study Evaluating the Effectiveness and Safety of Immunotherapy With Clustoid®/Clustek®/Alxoid® for the Treatment of Dermatophagoides/Blomia Tropicalis Allergy in Real-Life Conditions

House dust mites are the main source of allergies in indoor environments. They are predominant in coastal areas, with the Canary Islands being the autonomous community with the highest percentage of patients with rhinoconjunctivitis due to sensitisation to these mites (94.7%).

Immunotherapy is indicated for the treatment of allergic rhinoconjunctivitis and is capable of altering the natural course of allergic diseases.

The aim of the study was to evaluate the efficacy and safety of Clustoid® Max Forte in the treatment of patients with respiratory allergy to Dermatophagoides/Blomia tropicalis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Retrospective observational study of the effectiveness and safety of Clustoid® Max Forte for Dermatophagoides (D. pteronyssinus, D. farinae)/ Blomia tropicalis at concentrations of 30,000/30,000 Titer Units per milliliter (TU/mL) or 30,000/10,000 TU/mL in patients with allergic rhinitis/rhinoconjunctivitis with/without asthma, treated for a minimum of 1 year.

To assess effectiveness, the combined symptom and medication scores (PSPM) for rhinitis/rhinoconjunctivitis and asthma prior to treatment (T=0) and annually up to 5 years post-initiation (T=5) were studied and compared. To assess safety, adverse reactions were collected and evaluated.

Study Type

Observational

Enrollment (Actual)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Canary Islands
      • Santa Cruz de Tenerife, Canary Islands, Spain, 38002
        • Clínica Doctor García Robaina
      • Santa Cruz de Tenerife, Canary Islands, Spain, 38010
        • Nuestra Señora de Candelaria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients aged 5 to 65 years with respiratory allergic diseases (allergic rhinitis/rhinoconjunctivitis with or without asthma) who have been treated or are being treated with Clustoid® Max Forte Dermatophagoides/Blomia tropicalis, with allergen code MM09/M608, for the two concentrations mentioned above.

Description

Inclusion Criteria:

  1. The study population consists of patients with respiratory allergic disease who are indicated for treatment with Clustoid® Max Forte immunotherapy according to standard clinical practice.
  2. Age between 5 and 65 years, with no gender differences.
  3. Who have received immunotherapy for at least one year.

Exclusion Criteria:

1.Patients who have received immunotherapy with airborne allergens prior to the treatment to be evaluated in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with respiratory allergic diseases treated with Clustoid Max Forte
Patients with respiratory allergic diseases (allergic rhinitis/rhinoconjunctivitis with or without asthma) who have been treated or are being treated with Clustoid® Max Forte Dermatophagoides/Blomia tropicalis, for both concentrations 30,000/30,000 TU/mL and 30,000/10,000 TU/mL. (ATC code: V01AA07)
Biological: Clustoid® Max Forte
Clustoid® Max Forte for Dermatophagoides (D. pteronyssinus, D. farinae)/ Blomia tropicalis at concentrations of 30,000/30,000 TU/mL or 30,000/10,000 TU/mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rhinoconjunctivitis Symptom Score (RSS) for the Treatment of Dermatophagoides/Blomia tropicalis Allergy
Time Frame: 12-60 months

Rhinoconjunctivitis Symptom Score (RSS) shall be counted before starting immunotherapy and annually during treatment, ensuring comparability by evaluating the same season each year.

Evaluation of six symptoms: nasal pruritus, sneezing, rhinorrhoea, nasal obstruction (for rhinitis), ocular pruritus/redness, watery eyes (for conjunctivitis). Symptom Scores for rhinoconjunctivitis (RSS) will be the sum of scores for all six symptoms divided by 6.

Each symptom scored from 0 to 3. The assessment criteria for each symptom shall be as follows:

0 = no symptoms

  1. = mild (present, minimal awareness, easily tolerated)
  2. = moderate (clear awareness but tolerable)
  3. = severe (hard to tolerate, interferes with daily activity or sleep)
12-60 months
Asthma Symptom Score (ASS) for the Treatment of Dermatophagoides/Blomia tropicalis Allergy
Time Frame: 12-60 months

Asthma Symptom Score (ASS) shall be counted before starting immunotherapy and annually during treatment, ensuring comparability by evaluating the same season each year.

Evaluation of four symptoms: cough, dyspnoea, chest tightness, wheezing. Asthma Symptom Score (ASS) will be the sum for all four symptoms divided by 4.

Each symptom scored from 0 to 3. The assessment criteria for each symptom shall be as follows:

0 = no symptoms

  1. = mild (present, minimal awareness, easily tolerated)
  2. = moderate (clear awareness but tolerable)
  3. = severe (hard to tolerate, interferes with daily activity or sleep)
12-60 months
Asthma Medication Score (AMS) for the Treatment of Dermatophagoides/Blomia tropicalis Allergy
Time Frame: 12-60 months

Asthma Medication Score (AMS) shall be counted before starting immunotherapy and annually during treatment, ensuring comparability by evaluating the same season each year.

0 = no medication 0.5 = short-acting β2-agonists (SABA) on demand

  1. = low-dose inhaled corticosteroids (ICS) / antileukotrienes (LTRA) 1.5 = low-dose ICS + Long-Acting Beta-Agonist (LABA) / medium-dose ICS ± LTRA ± SABA
  2. = medium-dose ICS + LABA ± LTRA ± SABA 2.5 = high-dose ICS + LABA ± LTRA ± SABA
  3. = high-dose ICS + LABA + systemic corticosteroids (CS) ± LTRA ± SABA
12-60 months
Rhinoconjunctivitis Medication Score (RMS) for the Treatment of Dermatophagoides/Blomia tropicalis Allergy
Time Frame: 12-60 months

Rhinoconjunctivitis Medication Score (RMS) shall be counted before starting immunotherapy and annually during treatment, ensuring comparability by evaluating the same season each year.

0 = no medication

  1. = oral/topical antihistamines (eyes and/or nose)
  2. = intranasal corticosteroids with/without antihistamines
  3. = oral corticosteroids with/without antihistamines
12-60 months
Combined Symptom and Medication Scores for asthma (ACSMS) in the Treatment of Dermatophagoides/Blomia tropicalis Allergy
Time Frame: 12-60 months
Combined Symptom and Medication Scores for asthma (ACSMS) shall be counted before starting immunotherapy and annually during treatment, ensuring comparability by evaluating the same season each year.
12-60 months
Combined Symptom and Medication Scores for Rhinoconjunctivitis (RCSMS) in the Treatment of Dermatophagoides/Blomia tropicalis Allergy
Time Frame: 12-60 months
Combined Symptom and Medication Scores for rhinoconjunctivitis (RCSMS) shall be counted before starting immunotherapy and annually during treatment, ensuring comparability by evaluating the same season each year.
12-60 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Associated With Clustoid® Max Forte
Time Frame: 12-60 months
Number, type, nature, intensity, and severity of treatment-emergent adverse reactions, including local and systemic events, in subjects receiving immunotherapy for Dermatophagoides/Blomia tropicalis allergy.
12-60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inmunotek S.L.

Investigators

  • Principal Investigator: Cristina González Colino, Hospital Universitario Nuestra Señora de Candelaria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2025

Primary Completion (Actual)

August 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

January 30, 2026

First Submitted That Met QC Criteria

February 16, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITK-CLU-2024-09

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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