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Completed

NCT Number: NCT02488447

Study for Evaluating Life Quality in Patients With Rhinoconjunctivitis

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.

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Key information

Conditions

Allergic Rhinoconjunctivitis Hypersensitivity Immune System Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Complejp Hospitalario de Cáceres, Cáceres, Extremadura, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: One Year

Secondary outcomes

  1. Adherence as measured by patient diary

    Time frame: One Year

  2. Treatment Satisfaction as measured by visual analogue scale

    Time frame: One Year

Sponsors and collaborators

Lead sponsor

Roxall Medicina España S.A

Industry

Registry information

Official study 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

Acronym: ÍCARA

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 2, 2015
Registry last updated
Oct 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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