Study for Evaluating Life Quality in Patients With Rhinoconjunctivitis

Prospective Study for Evaluating Life Quality and Its Determinant Factors as Treatment Adherence and Immunotherapy Satisfaction in Patients With Rhinoconjunctivitis With or Without Asthma, Sensitized at Least to One Aeroallergen

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02488447

Acronym

ÍCARA

Enrollment

215

Registered

2015-07-02

Start date

2015-05-31

Completion date

2017-05-25

Last updated

2017-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinoconjunctivitis

Keywords

Allergy, Allergic rhinoconjunctivitis, Immunotherapy, Life Quality, Adherence

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Life Quality as measured by RQLQ questionaire (≥12years)	One Year

Secondary

Measure	Time frame
Adherence as measured by patient diary	One Year
Treatment Satisfaction as measured by visual analogue scale	One Year

Countries

Spain

Outcome results