Clinical trial NCT02488447: Study for Evaluating Life Quality in Patients With Rhinoconjunctivitis
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Rhinoconjunctivitis
Keywords: Allergy
Allergic rhinoconjunctivitis
Immunotherapy
Life Quality
Adherence
Lead sponsor: Roxall Medicina España S.A
Sponsor class: INDUSTRY
First posted: 2015-07-02
Enrollment: 215
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by Rhinoconjunctivitis with or without asthma

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.


Eligibility 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

Primary outcomes:
measure: Life Quality as measured by RQLQ questionaire (≥12years)
timeFrame: One Year
Secondary outcomes:
measure: Adherence as measured by patient diary
timeFrame: One Year
measure: Treatment Satisfaction as measured by visual analogue scale
timeFrame: One Year
Other outcomes:
Locations:
city: Cáceres
country: Spain
facility: Complejp Hospitalario de Cáceres
state: Extremadura
city: La Coruña
country: Spain
facility: Complejo Hospitalario Universitario La Coruña
state: Galicia
city: Madrid
country: Spain
facility: Hospital Central de la Cruz Roja
city: Madrid
country: Spain
facility: Hospital Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital del Tajo
city: Madrid
country: Spain
facility: Hospital del Norte Infanta Sofía
city: Madrid
country: Spain
facility: Hospital Universitario del Henares
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Alcorcón
city: Madrid
country: Spain
facility: Hospital universitario de Fuenlabrada
city: Valladolid
country: Spain
facility: Centro Médico Alianza Médica
city: Zamora
country: Spain
facility: Hospital Virgen de la Concha
city: Zaragoza
country: Spain
facility: Hospital Universitario Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Royo Vilanova
Study officials:
affiliation: Complejo Hospitalario de Cáceres
name: Francisco Javier Fernández Arbeiza, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario de Fuenlabrada
name: Eloína González Mancebo, Dra.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario del Henares
name: Vanesa Sánchez, Dra.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Central de la Cruz Roja
name: Jose Julio Laguna, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Médico Alianza Médica
name: Alicia Alonso, Dra.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Virgen de la Concha
name: Ana Mª Callejo, Dra.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital del Tajo
name: Mª Jesús Trujillo, Dra.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital 12 de Octubre
name: Ruth Mielgo, Dra.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Fundación Jiménez Díaz
name: Javier Cuesta, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Fundación Alcorcón
name: Mónica Rodríguez, Dra.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital del Norte, Infanta Sofía
name: Mª Antonia Padial, Dra.
role: PRINCIPAL_INVESTIGATOR
affiliation: Complejo Hospitalario La Coruña
name: Raquel López, Dra.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico Lozano Blesa
name: Carlos Colás, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Royo Vilanova
name: Ignacio Pérez, Dr.
role: PRINCIPAL_INVESTIGATOR
References: