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

October 19, 2017 updated by: Roxall Medicina España S.A

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
215

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre
      • Madrid, Spain, 28040
        • Hospital Fundación Jiménez Díaz
      • Madrid, Spain, 28942
        • Hospital Universitario de Fuenlabrada
      • Madrid, Spain, 28922
        • Hospital Universitario Fundacion Alcorcon
      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Life Quality as measured by RQLQ questionaire (≥12years)
Time Frame: One Year
One Year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Adherence as measured by patient diary
Time Frame: One Year
One Year
Treatment Satisfaction as measured by visual analogue scale
Time Frame: One Year
One Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Roxall Medicina España S.A

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 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 Clinico Lozano Blesa
  • Principal Investigator: Ignacio Pérez, Dr., Hospital Royo Vilanova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 25, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 25, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 20, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BIA-ALE-2014-01
  • ÍCARA (Other Identifier: Roxall Medicina España S.A.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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