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Completed

NCT Number: NCT07427576

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

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.

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Key information

Conditions

Mite Allergy Asthma Bronchial Diseases Dermatophagoides Farinae Allergy Dermatophagoides Pteronyssinus Allergy Dust Mite Allergy Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial Rhinoconjunctivitis

Age range

5 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clínica Doctor García Robaina, Santa Cruz de Tenerife, Canary Islands, Spain

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Age between 5 and 65 years, with no gender differences.
  • 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.

Treatment and study plan

Clustoid® Max Forte

Biological

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

Primary outcomes

  1. 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

    • = mild (present, minimal awareness, easily tolerated)
    • = moderate (clear awareness but tolerable)
    • = severe (hard to tolerate, interferes with daily activity or sleep)

  2. 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

    • = mild (present, minimal awareness, easily tolerated)
    • = moderate (clear awareness but tolerable)
    • = severe (hard to tolerate, interferes with daily activity or sleep)

  3. 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

    • = low-dose inhaled corticosteroids (ICS) / antileukotrienes (LTRA) 1.5 = low-dose ICS + Long-Acting Beta-Agonist (LABA) / medium-dose ICS ± LTRA ± SABA
    • = medium-dose ICS + LABA ± LTRA ± SABA 2.5 = high-dose ICS + LABA ± LTRA ± SABA
    • = high-dose ICS + LABA + systemic corticosteroids (CS) ± LTRA ± SABA

  4. 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

    • = oral/topical antihistamines (eyes and/or nose)
    • = intranasal corticosteroids with/without antihistamines
    • = oral corticosteroids with/without antihistamines

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Inmunotek S.L.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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