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.
Study Type
OBSERVATIONAL
Enrollment
140
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
Clínica Doctor García Robaina
Santa Cruz de Tenerife, Canary Islands, Spain
Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Canary Islands, Spain
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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12-60 months
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