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

NCT07427576 | Completed

• 1 other identifier: ITK-CLU-2024-09
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 2

Brief 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%). 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.

Conditions

Mite Allergy; Dermatophagoides Farinae Allergy; Dermatophagoides Pteronyssinus Allergy; Rhinitis, Allergic; Asthma; Rhinoconjunctivitis

Keywords

Allergy; immunotherapy; Blomia tropicalis Allergy

Outcome Measures

Primary Outcomes (7)

• 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)

  12-60 months

• 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)

  12-60 months

• 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

  12-60 months

• 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

  12-60 months

• 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.

  12-60 months

• 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.

  12-60 months

• 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.

  12-60 months

Study Arms (1)

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

Interventions

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

Patients with respiratory allergic diseases treated with Clustoid Max Forte

Eligibility Criteria

• Age: 5 Years - 65 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Inmunotek S.L.: lead

Study Sites (2)

Clínica Doctor García Robaina

Santa Cruz de Tenerife, Canary Islands, 38002, Spain

Location

Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Canary Islands, 38010, Spain

Location

Related Publications (4)

• 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.

  PMID: 27939406 BACKGROUND

• 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.

  PMID: 36789565 BACKGROUND

• 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.

  PMID: 37904678 BACKGROUND

• 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.

  PMID: 36119655 BACKGROUND

MeSH Terms

Conditions

Dust Mite Allergy; Rhinitis, Allergic; Asthma; Hypersensitivity

Condition Hierarchy (Ancestors)

Rhinitis, Allergic, Perennial; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Immune System Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Cristina González Colino

  Hospital Universitario Nuestra Señora de Candelaria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 23, 2026
• Study Start: March 31, 2025
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

ES (2)