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Mite AllergyNCT07427576

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

An observational study of Mite Allergy and Dermatophagoides Farinae Allergy, run by Inmunotek S.L. at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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%). Read more about this study

Who is it for?
Ages 5 to 65 years
What is being tested?
Clustoid® Max Forte
How many people
140 participants
Where
2 sitesSpain
Study dates
31 Mar 2025to 31 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 65 years
  • All sexes
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Clínica Doctor García Robaina

    Santa Cruz de Tenerife, Canary Islands, 38002

  • Nuestra Señora de Candelaria

    Santa Cruz de Tenerife, Canary Islands, 38010

Other trials in Spain

About this study

Official 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

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.

Read the 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.

Being tested
Clustoid® Max Forte
Keywords
Allergy, immunotherapy, Blomia tropicalis Allergy
Medical subject headings
Dust Mite Allergy, Rhinitis, Allergic, Asthma, Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clustoid® Max ForteBiological

    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

Study groups in NCT07427576
Study groupRoleWhat they receive
Patients with respiratory allergic diseases treated with Clustoid Max FortePatients 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)
Receives: Biological: Clustoid® Max Forte

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rhinoconjunctivitis Symptom Score (RSS) for the Treatment of Dermatophagoides/Blomia tropicalis Allergy

    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)

    Measured: 12-60 months

  2. Asthma Symptom Score (ASS) for the Treatment of Dermatophagoides/Blomia tropicalis Allergy

    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)

    Measured: 12-60 months

  3. Asthma Medication Score (AMS) for the Treatment of Dermatophagoides/Blomia tropicalis Allergy

    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

    Measured: 12-60 months

  4. Rhinoconjunctivitis Medication Score (RMS) for the Treatment of Dermatophagoides/Blomia tropicalis Allergy

    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

    Measured: 12-60 months

  5. Combined Symptom and Medication Scores for asthma (ACSMS) in the Treatment of Dermatophagoides/Blomia tropicalis Allergy

    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.

    Measured: 12-60 months

  6. Combined Symptom and Medication Scores for Rhinoconjunctivitis (RCSMS) in the Treatment of Dermatophagoides/Blomia tropicalis Allergy

    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.

    Measured: 12-60 months

  7. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Associated With Clustoid® Max Forte

    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.

    Measured: 12-60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2026
  2. Study start31 Mar 2025
  3. Primary completion31 Aug 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07427576
Sponsor's protocol ID
ITK-CLU-2024-09
Status last verified
Feb 2026
First submitted
30 Jan 2026
Last updated
23 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Guzman-Fulgencio M, Caballero R, Lara B, Mena M, Tejera M, Sastre A, Subiza JL, Fernandez-Caldas E, Casanovas M. Safety of immunotherapy with glutaraldehyde modified allergen extracts in children and adults. Allergol Immunopathol (Madr). 2017 Mar-Apr;45(2):198-207. doi: 10.1016/j.aller.2016.08.008. Epub 2016 Dec 7.

    PubMed 27939406

  • Sanchez J, Alvarez L, Garcia E. Real-world study: drug reduction in children with allergic rhinitis and asthma receiving immunotherapy. Immunotherapy. 2023 Mar;15(4):253-266. doi: 10.2217/imt-2022-0215. Epub 2023 Feb 15.

    PubMed 36789565

  • Rodriguez-Plata E, Callero Viera A, Ruiz-Garcia M, Gomez-Cardenosa A, Nieto E, Garcia-Robaina JC. House dust mite subcutaneous immunotherapy has sustained long-term effectiveness on allergic rhinitis and asthma: A 10-year follow-up. Immun Inflamm Dis. 2023 Oct;11(10):e1004. doi: 10.1002/iid3.1004.

    PubMed 37904678

  • Cardona-Villa R, Uribe-Garcia S, Calvo-Betancur VD, Cantillo JF, Fernandez-Caldas E. Efficacy and safety of subcutaneous immunotherapy with a mixture of glutaraldehyde-modified extracts of Dermatophagoides pteronyssinus, Dermatophagoides farinae , and Blomia tropicalis. World Allergy Organ J. 2022 Sep 8;15(9):100692. doi: 10.1016/j.waojou.2022.100692. eCollection 2022 Sep.

    PubMed 36119655

Questions about this trial

What is this clinical trial studying?

An observational study of Mite Allergy and Dermatophagoides Farinae Allergy, run by Inmunotek S.L. at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rhinoconjunctivitis Symptom Score (RSS) for the Treatment of Dermatophagoides/Blomia tropicalis Allergy (time frame: 12-60 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07427576, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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