This trial is active, not recruiting.

Condition allergic rhinoconjunctivitis
Sponsor BIAL Industrial Farmacéutica S.A.
Start date May 2015
End date March 2017
Trial size 202 participants
Trial identifier NCT02488447, BIA-ALE-2014-01, ÍCARA


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-crossover
Time perspective prospective

Primary Outcomes

Life Quality as measured by RQLQ questionaire (≥12years)
time frame: One Year

Secondary Outcomes

Adherence as measured by patient diary
time frame: One Year
Treatment Satisfaction as measured by visual analogue scale
time frame: One Year

Eligibility Criteria

Male or female participants at least 12 years old.

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

Additional Information

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
Principal investigator Francisco Javier Fernández Arbeiza, Dr.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by BIAL Industrial Farmacéutica S.A..