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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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
| 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
| 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
|
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Inclusion Criteria:
Exclusion Criteria:
1.Patients who have received immunotherapy with airborne allergens prior to the treatment to be evaluated in this study.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Cristina González Colino | Hospital Universitario Nuestra Señora de Candelaria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClĂnica Doctor GarcĂa Robaina | Santa Cruz de Tenerife | Canary Islands | 38002 | Spain | ||
| Nuestra Señora de Candelaria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27939406 | Background | 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. | |
| 36789565 | Background |
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| 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
| 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 |
| Santa Cruz de Tenerife |
| Canary Islands |
| 38010 |
| Spain |
| 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. |
| 37904678 | 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. |
| 36119655 | 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. |
| ID | Term |
|---|---|
| D000092542 | Dust Mite Allergy |
| D065631 | Rhinitis, Allergic |
| D001249 | Asthma |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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