Study for Evaluating Life Quality in Patients With Rhinoconjunctivitis

Allergic Rhinoconjunctivitis Clinical Trial

— ÍCARA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02488447
• Other study ID #: BIA-ALE-2014-01
• Secondary ID: ÍCARA
• Status: Completed
• Phase: N/A
• First received: June 25, 2015
• Last updated: October 19, 2017
• Start date: May 2015
• Est. completion date: May 25, 2017

Study information

• Verified date: October 2017
• Source: Roxall Medicina España S.A
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: May 25, 2017
• Est. primary completion date: May 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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 , ß-blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)

• Female patients who are pregnant or breast-feeding

Related Conditions & MeSH terms

• Allergic Rhinoconjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Locations

Country	Name	City	State
Spain	Complejp Hospitalario de Cáceres	Cáceres	Extremadura
Spain	Complejo Hospitalario Universitario La Coruña	La Coruña	Galicia
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Central de la Cruz Roja	Madrid
Spain	Hospital del Norte Infanta Sofía	Madrid
Spain	Hospital del Tajo	Madrid
Spain	Hospital Fundación Jiménez Díaz	Madrid
Spain	Hospital universitario de Fuenlabrada	Madrid
Spain	Hospital Universitario del Henares	Madrid
Spain	Hospital Universitario Fundación Alcorcón	Madrid
Spain	Centro Médico Alianza Médica	Valladolid
Spain	Hospital Virgen de la Concha	Zamora
Spain	Hospital Royo Vilanova	Zaragoza
Spain	Hospital Universitario Lozano Blesa	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Roxall Medicina España S.A

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Life Quality as measured by RQLQ questionaire (=12years)		One Year
Secondary	Adherence as measured by patient diary		One Year
Secondary	Treatment Satisfaction as measured by visual analogue scale		One Year