In short
Clinical trials are studying BLOMIA TROPICALIS POLYMERIZED EXTRACT as part of a vaccine for dust mite and Blomia tropicalis allergy. These studies look at safety and how well it works in people with moderate-to-severe allergic rhinitis/rhinoconjunctivitis, with or without mild-to-moderate controlled asthma.
Key points
- BLOMIA TROPICALIS POLYMERIZED EXTRACT is being studied in a Phase 3 clinical trial for dust mite and Blomia tropicalis allergy. The trial includes people aged 12 to 65 years with moderate-to-severe persistent allergic rhinitis/rhinoconjunctivitis, with or without mild-to-moderate controlled asthma. The study compares the active treatment with a placebo. The main outcome is the Rhinoconjunctivitis Combined Symptom and Medication Score, measured after one year of treatment over a 4-week period. The trial is authorised and plans to enroll 120 participants.
Trial overview
The available study is an interventional clinical trial, which means participants receive a study treatment and the results are compared with another group. It is designed to assess the efficacy and safety of a vaccine for dust mite and Blomia tropicalis allergy.
The trial is authorised and includes 120 participants.
Who can join the study
The trial is for people aged 12 to 65 years who have moderate-to-severe persistent allergic rhinitis/rhinoconjunctivitis. People may also have mild-to-moderate controlled allergic asthma, as long as it is controlled.
This means the study is focused on patients with allergy problems that affect the nose and eyes, and in some cases the lungs as well.
What is being tested
The study treatment is BLOMIA TROPICALIS POLYMERIZED EXTRACT as part of a suspension for injection given under the skin. The active treatment contains D.pteronyssinus/D.farinae/B.tropicalis polymerized extracts 10,000 TU/mL, and it is compared with a placebo that has the same solution and presentation but no active ingredients.
The trial is testing whether this investigational medicinal product can help as an aetiological treatment, meaning a treatment aimed at the cause of the allergy.
Trial phase and status
This study is a Phase 3 trial. Phase 3 trials are later-stage studies that usually look at how well a treatment works in a larger group of patients while continuing to watch safety.
The current status is authorised.
Outcomes measured
The main outcome is the Rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS). This score combines how bad the symptoms are and how much medication is used, so researchers can judge overall control of the allergy.
The score is measured over 4 weeks after one year of treatment, and it is recorded in the participant’s diary.
Patient-friendly terms
- Placebo means a look-alike treatment used for comparison, but it does not contain active ingredients.
- Subcutaneous injection means the treatment is given under the skin.
- Allergic rhinitis/rhinoconjunctivitis means allergy symptoms in the nose, and sometimes the eyes too.
- Controlled asthma means asthma that is stable and not badly affecting the person most of the time.
- Participant diary is the record used by the study volunteer to write down symptoms and other study information.