Trials / Completed
CompletedNCT07427576
Retrospective Study Evaluating the Effectiveness and Safety of Immunotherapy With Clustoid Max Forte
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 140 (actual)
- Sponsor
- Inmunotek S.L. · Industry
- Sex
- All
- Age
- 5 Years – 65 Years
- Healthy volunteers
- —
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.
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.
Conditions
- Mite Allergy
- Dermatophagoides Farinae Allergy
- Dermatophagoides Pteronyssinus Allergy
- Rhinitis, Allergic
- Asthma
- Rhinoconjunctivitis
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Clustoid® Max Forte | 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 |
Timeline
- Start date
- 2025-03-31
- Primary completion
- 2025-08-31
- Completion
- 2025-12-31
- First posted
- 2026-02-23
- Last updated
- 2026-02-23
Locations
2 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT07427576. Inclusion in this directory is not an endorsement.