Study for Evaluating Life Quality in Patients With Rhinoconjunctivitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

215 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-05-25

Brief Summary

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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.

Detailed Description

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Conditions

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Allergic Rhinoconjunctivitis

Keywords

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Allergy Allergic rhinoconjunctivitis Immunotherapy Life Quality Adherence

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

* 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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Role: PRINCIPAL_INVESTIGATOR

Hospital Royo Vilanova

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ÍCARA

Identifier Type: OTHER

Identifier Source: secondary_id

BIA-ALE-2014-01

Identifier Type: -

Identifier Source: org_study_id

Study for Evaluating Life Quality in Patients With Rhinoconjunctivitis

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Roxall Medicina España S.A

Responsible Party

Principal Investigators

Francisco Javier Fernández Arbeiza, Dr.

Eloína González Mancebo, Dra.

Vanesa Sánchez, Dra.

Jose Julio Laguna, Dr.

Alicia Alonso, Dra.

Ana Mª Callejo, Dra.

Mª Jesús Trujillo, Dra.

Ruth Mielgo, Dra.

Javier Cuesta, Dr.

Mónica Rodríguez, Dra.

Mª Antonia Padial, Dra.

Raquel López, Dra.

Carlos Colás, Dr.

Ignacio Pérez, Dr.

Locations

Complejp Hospitalario de Cáceres

Complejo Hospitalario Universitario La Coruña

Hospital Central de la Cruz Roja

Hospital Fundación Jiménez Díaz

Hospital 12 de Octubre

Hospital del Tajo

Hospital del Norte Infanta Sofía

Hospital Universitario del Henares

Hospital Universitario Fundación Alcorcón

Hospital universitario de Fuenlabrada

Centro Médico Alianza Médica

Hospital Virgen de la Concha

Hospital Universitario Lozano Blesa

Hospital Royo Vilanova

Countries

Other Identifiers

ÍCARA

BIA-ALE-2014-01