International, multicenter, blinded phase III clinical trial to assess the diagnostic efficacy of the skin prick test from ROXALL (SPT-RX) with different allergen extract solutions for in vivo diagnosis of IgE mediated allergies

Condition studied

Patients suffering from rhinitis / rhinoconjunctivitis, with well-controlled mild-to-moderate asthma or without asthma, due to the exposure to any of the allergen sources under investigation, for at least 2 years in case of seasonal allergenic sources or for at least 1 year in case of perennial allergenic sources.

Investigational medicinal product(s)

Eligibility

Primary endpoint

The primary efficacy endpoint will be related to the two main parameters for each allergenic extract that allow for distinction between allergic from non-allergic patients and which should be above 0.80 as lower limit of 90% CI each: a. Sensitivity (S). b. Specificity (E)

Endpoint detail

Positive Predictive Value (PPV): is the probability that patients who tested positive on the SPT-RX under investigation are truly allergic to a specific allergen source, Negative Predictive Value (NPV): is the probability that patients who tested negative on the SPT-RX under investigation are truly non-allergic to a specific allergen source, Positive Likelihood ratio: is the probability that a patient with the disease will have a positive test result, divided by the probability that a patient without the disease will have a positive result., Negative Likelihood ratio: is the probability that a patient with the disease will have a negative test result, divided by the probability that a patient without the disease will have a negative result., Efficiency (or Accuracy) is the percentage of patients for whom the test results coincide with the clinical history., Wheal size: the mean diameter size, in mm, induced by each allergen extract and by positive and negative tested controls. According to Ruëff et al. (2011) and Heinzerling et al. (2013), a wheal diameter ≥ 3 mm will be considered a positive result.