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

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

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinoconjunctivitis

• Study Type: Observational
• Enrollment (Actual): 215

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28041
    • Hospital 12 de Octubre
  • Madrid, Spain, 28040
    • Hospital Fundación Jimenez Diaz
  • Madrid, Spain, 28942
    • Hospital Universitario de Fuenlabrada
  • Madrid, Spain, 28922
    • Hospital Universitario Fundación Alcorcón
  • Madrid, Spain, 28003
    • Hospital Central de la Cruz Roja
  • Madrid, Spain, 28300
    • Hospital del Tajo
  • Madrid, Spain, 28702
    • Hospital del Norte Infanta Sofía
  • Madrid, Spain, 28822
    • Hospital Universitario del Henares
  • Valladolid, Spain, 47001
    • Centro Médico Alianza Médica
  • Zamora, Spain, 49022
    • Hospital Virgen de la Concha
  • Zaragoza, Spain, 50009
    • Hospital Universitario Lozano Blesa
  • Zaragoza, Spain, 50015
    • Hospital Royo Vilanova
  • Extremadura
    • Cáceres, Extremadura, Spain, 10002
      • Complejp Hospitalario de Cáceres
  • Galicia
    • La Coruña, Galicia, Spain, 15405
      • Complejo Hospitalario Universitario La Coruna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients affected by Rhinoconjunctivitis with or without asthma

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Roxall Medicina España S.A
• Investigators: Principal Investigator: Francisco Javier Fernández Arbeiza, Dr., Complejo Hospitalario de Cáceres; Principal Investigator: Eloína González Mancebo, Dra., Hospital Universitario de Fuenlabrada; Principal Investigator: Vanesa Sánchez, Dra., Hospital Universitario del Henares; Principal Investigator: Jose Julio Laguna, Dr., Hospital Central de la Cruz Roja; Principal Investigator: Alicia Alonso, Dra., Centro Médico Alianza Médica; Principal Investigator: Ana Mª Callejo, Dra., Hospital Virgen de la Concha; Principal Investigator: Mª Jesús Trujillo, Dra., Hospital del Tajo; Principal Investigator: Ruth Mielgo, Dra., Hospital 12 de Octubre; Principal Investigator: Javier Cuesta, Dr., Hospital Fundación Jimenez Diaz; Principal Investigator: Mónica Rodríguez, Dra., Hospital Fundación Alcorcón; Principal Investigator: Mª Antonia Padial, Dra., Hospital del Norte, Infanta Sofía; Principal Investigator: Raquel López, Dra., Complejo Hospitalario La Coruña; Principal Investigator: Carlos Colás, Dr., Hospital Clinico Lozano Blesa; Principal Investigator: Ignacio Pérez, Dr., Hospital Royo Vilanova

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): May 25, 2017
• Study Completion (Actual): May 25, 2017

Study Registration Dates

• First Submitted: June 25, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimate): July 2, 2015

Study Record Updates

• Last Update Posted (Actual): October 20, 2017
• Last Update Submitted That Met QC Criteria: October 19, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Adherence; Allergy; Immunotherapy; Allergic rhinoconjunctivitis; Life Quality
• Additional Relevant MeSH Terms: Eye Diseases; Conjunctival Diseases; Conjunctivitis
• Other Study ID Numbers: BIA-ALE-2014-01; ÍCARA (Other Identifier: Roxall Medicina España S.A.)