Study for Evaluating Life Quality in Patients With Rhinoconjunctivitis (ÍCARA)

ROXALL

Status: Completed

Conditions: Allergic Rhinoconjunctivitis

Study type: Observational

Funder types: Industry

Identifiers

NCT02488447

ÍCARA (Other Identifier)

BIA-ALE-2014-01

Details and patient eligibility

About

The purpose of ths study is to evaluate changes in life quality of patients affected by rhinoconjuntivitis with or without asthma after immunotherapy treatment. It is an observational, prospective and comparative study before-after immunotherapy treatment with a one year follow-up.

Enrollment: 215 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Based on Routine Clinical Practice

Inclusion criteria:

• Patients affected by allergic rhinoconjunctivitis sensityzed to one or several aeroallergens.Although allergic rhinoconjunctivitis is the pathology under study, the inclusion of patients with mild concomitant asthma is allowed (GINA 2013)
• Patients older than 12 years old
• Patients being subsidiaries of receiving allergen immunotherapy treatment
• Patients who obtained a prick test result ≥ 3 mm diameter to any aeroallergen. Positive and negative control of the test should give consistent results.
• Patients with specific immunoglobulin E ≥ class 2 (CAP/PHADIA) to any aeroallergen.

Exclusion criteria (based on routine clinical practice):

• Patients with severe asthma or forzed expiratoy volumen in 1 second FEV1< 70% even if the are pharmacologically controlled .
• Patients with: immunological, cardiac, renal or hepatic illnesses or any other medical condition that the investigator seems relevant so as to interfere with the treatment.
• Patients with a previous history of anaphylaxis
• Patients under treatment with tricyclic antidepressives, phenothiazines , β-blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)
• Female patients who are pregnant or breast-feeding