Multicenter, double-blind, randomized, placebo-controlled phase III clinical trial in parallel groups which evaluates the clinical efficacy and safety of immunotherapy with the purified major allergen Cup a 1, in patients with moderate/severe allergic rhino conjunctivitis with or without controlled asthma, sensitized to Cupressaceae

Allergic rhinoconjunctivitis

The efficacy of the treatment will be evaluated based on the symptom frequency and severity score together with the Combined Symptom and Medication Score (CSMS), which will be obtained through a questionnaire completed by the patient during 2 successive pollen seasons

Symptom frequency and severity score. Results are compared between treatment arms and between pollen seasons, Score for Rescue medication use, Symptom-free days, Medication-free days, Extra visits and/or emergencies during the period of the clinical trial related to the pathology under study, Skin follow-up skin test with Cupressaceae extract and Cup a 1, Asthma and allergic rhinitis control assessed by ACT and modified ARIA, Visual Analog Scale (VAS) for the state of health performed by the patient, ESPRINT-15 questionnaire evaluation, Evaluation of immunological markers: IL-10, IL-13, INF-ƴ, specific IgE and specific IgG4 against Cupressus arizonica and Cup a 1, Conjunctival provocation against cupresaceae, Frequency of adverse events (AEs), serious AAs (SAEs) and ADRs, particularly systemic events according to the World Allergy Organization (WAO) 2010 classification

No related papers found yet.

Spain