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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the effectiveness and safety of subcutaneous immunotherapy in patients aged 12 to 65 who have mild to moderate rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma, caused by sensitivity to grass and olive pollen. This randomized, double-blind, placebo-controlled phase 3 trial aims to study allergy treatments to improve symptoms and reduce medication use over one year. Participants are randomly assigned to one of three groups: one receiving 10,000 TU/mL MG01 plus 10,000 TU/mL T517, another receiving 30,000 TU/mL MG01 plus 10,000 TU/mL T517, and a placebo group receiving the same solution without active ingredients. The allergen extracts come from a mixture of grasses and olive pollen, administered through subcutaneous injections. Treatment lasts for one year, evaluating different doses compared to placebo. During the study, participants will regularly record symptoms and medication use using a smartphone app. Researchers will monitor combined symptoms and medication scores as the primary outcome, along with medication-free days, symptom-free days, asthma exacerbations, quality of life tests for rhinitis and asthma, and immune response measures. Safety is closely followed through adverse reaction monitoring and immunological and security parameters over the 12-month treatment period.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of subcutaneous immunotherapy in patients aged 12 to 65 who have rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma, and who are sensitive to cupressaceae and grass pollen. This phase 3, multicenter, randomized, double-blinded, placebo-controlled trial aims to better understand treatment options for allergy symptoms related to these pollens. Participants will be randomly assigned to one of three groups: two groups receiving different doses of a purified and polymerized allergen extract from grasses and cupressaceae mixed with aluminum hydroxide, and one placebo group receiving a similar solution without active ingredients. The treatment will be given by subcutaneous injections and will last for 18 months. The study will monitor symptoms and medication use during the specific pollen seasons for cupressaceae (January to March) and grasses (May to June). Throughout the trial, participants will record their symptoms and medication intake using an electronic diary via a smartphone. Researchers will assess combined symptom and medication scores as the primary outcome, along with various secondary measures such as symptom-free days, medication-free days, asthma and rhinitis symptom scores, quality of life, immunological parameters, and safety. The total participation time for each subject is 18 months, during which their health and response to treatment will be closely monitored.