In short
Clinical trials involving Azelastine are studying how it performs in people with allergic eye and nose symptoms. The trial data here focuses on adult patients with moderate to severe allergic rhinitis/rhinoconjunctivitis, sometimes with asthma, and measures symptom control and treatment effect.
Key points
- Clinical trial data for Azelastine is linked here to a larger allergy study in adults with moderate to severe allergic rhinitis/rhinoconjunctivitis, with or without asthma, caused by house dust mite allergy. The study is a Phase 3 interventional trial and included 582 participants. It was randomized, double-blind, placebo-controlled, and multi-centre, which helps compare treatment groups in a fair way. The main result measured was the average daily Total Combined Rhinitis Score during the last 8 weeks of treatment. The trial was completed.
Trial overview
This trial record includes Azelastine as one of the study drugs listed in the intervention set, but the main study was designed to assess PURETHAL Mites Mixture 50,000 AUeq/mL subcutaneous immunotherapy in people with house dust mite allergy. The study looked at adults with moderate to severe allergic rhinitis/rhinoconjunctivitis, with or without asthma.
Who was studied
The study enrolled adult subjects, and the total enrollment was 582 people. The target condition was moderate to severe allergic rhinitis/rhinoconjunctivitis caused by house dust mite allergy, and some participants also had asthma.
Allergic rhinitis/rhinoconjunctivitis means allergy symptoms in the nose and eyes, such as sneezing, runny nose, itching, or watery eyes. The study focused on adults with more serious symptoms, not mild disease.
Study design and phase
This was an interventional study, which means researchers gave study treatments and compared outcomes across groups. It was also randomized, double-blind, and placebo-controlled, meaning people were assigned by chance, neither the participants nor the study team knew the group assignments, and one group received a placebo for comparison.
The study was conducted at multiple centres, so it was run in more than one location. The phase was Phase 3, which is a later stage of clinical research used to test how well a treatment works in a larger group of people.
What was measured
The main outcome was the average daily Total Combined Rhinitis Score during the last 8 weeks of treatment. This score is a combined number that adds together several symptom ratings, with a maximum of 24 points, to show how severe rhinitis symptoms are.
The brief summary says the study compared the average Total Combined Rhinitis Score during the last 8 weeks of one year of treatment, with a time window of about one year plus or minus one month. The goal was to see whether the active treatment group did better than placebo on symptom control.
Trial details
The trial title describes the study as a randomized, double-blind, placebo-controlled, multi-centre study of PURETHAL Mites Mixture 50,000 AUeq/mL subcutaneous immunotherapy in adult subjects with house dust mite allergy. The record also lists several other study drugs and test materials, including Azelastine, mometasone, loratadine, and various skin test and nasal challenge materials.
The trial status was Completed. Because the record focuses on the larger allergy study rather than Azelastine alone, the available data here should be read as part of a broader clinical research setting.