NCT02488447

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
215

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Typical duration for all trials

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 2, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2017

Completed
Last Updated

October 20, 2017

Status Verified

October 1, 2017

Enrollment Period

2.1 years

First QC Date

June 25, 2015

Last Update Submit

October 19, 2017

Conditions

Allergic Rhinoconjunctivitis

Keywords

AllergyAllergic rhinoconjunctivitisImmunotherapyLife QualityAdherence

Outcome Measures

Primary Outcomes (1)

  • Life Quality as measured by RQLQ questionaire (≥12years)

    One Year

Secondary Outcomes (2)

  • Adherence as measured by patient diary

    One Year

  • Treatment Satisfaction as measured by visual analogue scale

    One Year

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients affected by Rhinoconjunctivitis with or without asthma

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Complejp Hospitalario de Cáceres

Cáceres, Extremadura, 10002, Spain

Location

Complejo Hospitalario Universitario La Coruña

A Coruña, Galicia, 15405, Spain

Location

Hospital Central de la Cruz Roja

Madrid, 28003, Spain

Location

Hospital Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

Hospital del Tajo

Madrid, 28300, Spain

Location

Hospital del Norte Infanta Sofía

Madrid, 28702, Spain

Location

Hospital Universitario del Henares

Madrid, 28822, Spain

Location

Hospital Universitario Fundación Alcorcón

Madrid, 28922, Spain

Location

Hospital universitario de Fuenlabrada

Madrid, 28942, Spain

Location

Centro Médico Alianza Médica

Valladolid, 47001, Spain

Location

Hospital Virgen de la Concha

Zamora, 49022, Spain

Location

Hospital Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Hospital Royo Vilanova

Zaragoza, 50015, Spain

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • 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 Jiménez Díaz

    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 Clínico Lozano Blesa

    PRINCIPAL INVESTIGATOR

  • Ignacio Pérez, Dr.

    Hospital Royo Vilanova

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2015

First Posted

July 2, 2015

Study Start

May 1, 2015

Primary Completion

May 25, 2017

Study Completion

May 25, 2017

Last Updated

October 20, 2017

Record last verified: 2017-10

Locations

ES(14)