ALTO, An international non-interventional registry on the quality of life of patients with grass pollen-induced Allergic Rhinitis Treated with Oralair®

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Effectiveness study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Health Related Quality of Life

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  International, prospective, observational, multicentre, longitudinal, pharmacoepidemiological study

Study drug and medical condition

• Medicinal product name, other:
  ORALAIR*31CPR SUBL 100IR-300IR
• Medical condition to be studied:
  Rhinitis allergic

Population studied

• Age groups:
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  2500

Study design details

• Main study objective:
  The purpose of the present study is to describe patient’s perception of quality of life and effectiveness of Oralair® over a follow-up period of up to 5 years, in real-life settings.
• Outcomes:
  Change of the health related generic and disease specific Quality of Lifemeasured during the grass-pollen seasons. - Disease intensity according to the Visual Analogic Scale (VAS)- Effectiveness of Oralair® in allergic rhinitis management- Patient compliance to Oralair®- Socio-economic impact of Oralair® (physician visits, hospitalizations,sick-leaves related to allergic rhinitis)
• Data analysis plan:
  Analysis of the primary and secondary objectives will be performed on the Study Population. Change from Screening visit will be calculated and described at each time point of the 2nd phase of the study: -scores of 7 domains (Activity limitation, Sleep problems, Nose symptoms, Eye symptoms, Non-nose/eye symptoms, Practical problems and Emotional function) and the overall score of the RQLQ(S)+12 will be described,-scores of the 8 dimensions (Physical functioning, Role-physical limitations, Bodily pain, General health, Vitality, Mental health, Role-emotional limitations, Social functioning) of the SF-12 v.2 / SF10 v.2 will be described,-the perception of disease intensity (VAS) will be described,-effectiveness of Oralair in allergic rhinitis management will be described,-patient compliance to Oralair will be described for each year of the treatment period,-medical resources use will be described for each year of the whole study period.