A non-interventional observational retrospective study for the study of the risk factors associated to the related to treatment adverse events occurred by the administration of allergen specific immunotherapy administered by sublingual route (ALK-SLI-2013-01)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  A non-interventional, observational, retrospective, multi-centre, open-label study

Population studied

• Short description of the study population:
  1. Patients diagnosed of allergic rhinoconjunctivitis with/without mild to moderate allergic asthma by allergic sensitization to: grass, Olea, or House Dust Mites (D. pteronyssinus/D. farinae); 2. Allergic sensitization diagnosed by cutaneous test (skin pricktest _SPT-) and/or specific IgE according to the common clinical routine of each investigator.; 3. Patients treated with SLIToneULTRA® for at least 3 months previously to his/her inclusion in the study; 4. Patients able to understand and answer on his/her own the questionnaires used in the study; 5. Patients above 5 years of age, according to the clinical routine of each investigator; 6. Patients that give their consent in writing to participate in the study. In case of patients between 12-17 years old the representative’s consent should accompany the own patient’s consent and in patients < 12 years old the consent will be obtained from the patient representative.
• Age groups:
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  To try of determining, in a real-life setting, the possible risk factors –associated to the patients or to the allergen extract- that may influence on the appearance of related to treatment adverse events occurred by the administration of SLIToneULTRA®.
• Outcomes:
  Incidence of eventsadverse, Adherence to the treatment through the Morisky-Green questionnaire and satisfaction through the SATMED-Q questionnaire
• Data analysis plan:
  A descriptive analysis for all data collected will be held in the CRD.