Treatment Modalities in Children and Adolescents Suffering From HDM-induced Allergic Rhinitis and/or Asthma
Condition: Allergy
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      Two-stage, prospective, observational, real-world study of HDM-SLIT-naïve children (aged
      5-11) and adolescents (aged 12-17) consulting allergists or other specialist physicians in
      France for an HDM-induced allergy. Physician- and/or patient-reported data on clinical
      symptoms, sensitization, patient profiles, symptom burdens, patient-physician dialogue, HDM
      SLIT regimens, and effectiveness were recorded on inclusion, and then again 6 to 12 months
      after the prescription of an HDM SLIT solution.

      The study's primary objective was to describe treatment modalities in children (aged from 5
      to 11) and adolescents (aged from 12 to 17) with suspected HDM-induced AR or allergic asthma
      consulting an allergist or another specialist physician in France.
    

Detailed description: 
      Study design:

      This was an observational, non-interventional, prospective, multicentre study of real-life
      clinical practice in France (the PROTECT study).

      Allergists and other specialist physicians with expertise in allergy were each invited to
      recruit up to 8 paediatric patients (aged 5 to 17) consulting for an indication of
      HDM-induced allergy and who had not previously received HDM SLIT.

      The PROTECT study a two-stage study and comprised:

        1. A cross-sectional analysis (performed during the inclusion visit)

             -  At the start of the study, each investigating physician filled out a detailed
                questionnaire that gathered information on demographics, the type of medical
                practice (a private office, a hospital department, or both), reasons for
                prescribing HDM SLIT, and whether or not he/she typically discussed the following
                topics with a patient suffering from HDM allergy: the risks associated with HDM
                allergy, allergen avoidance, the principle underlying treatment with symptomatic
                medications, the principle underlying AIT (including SLIT), AIT procedures and
                regimens, and the possible benefits and limits of AIT.

             -  At the inclusion visit, the physician filled out a detailed case report form (CRF)
                for each patient. The CRF was used to gather data on demographics, smoking status,
                the presence of absence of a pet at home, the patient's personal and family medical
                history, the patient's pathways, diagnostic data, and reasons for seeking to be
                treated (or not) with AIT. Furthermore, each included patient filled out an
                inclusion questionnaire on his/her reasons for visiting the allergist, on his/her
                allergic symptoms, the impact of these symptoms on everyday life, the times of the
                year when the symptoms were most prevalent and/or intense, and overall satisfaction
                with regard to symptomatic medications. Patients receiving a prescription for HDM
                SLIT at the inclusion visit also had to comment on their knowledge of allergic
                diseases and AIT, their reasons for seeking or agreeing to undergo HDM SLIT, and
                their expectations of HDM SLIT.

        2. A longitudinal analysis with between 6 and 12 months of follow-up

             -  At the follow-up visit between 6 and 12 months after inclusion, the investigating
                physician filled out a CRF on the duration of the course of HDM SLIT, the change
                over time in the patient's allergic symptoms, and whether HDM SLIT was to be
                continued or not. Similarly, patients having participated in the longitudinal
                analysis filled out a follow-up questionnaire on the change over time in their
                allergic symptoms, and their overall opinion of HDM SLIT.

      Study's primary objective:

      The study's primary objective was to describe treatment modalities in children (aged from 5
      to 11) and adolescents (aged from 12 to 17) with HDM-induced allergy according to their
      clinical profile, consulting an allergist or another specialist physician in France.

      Sample size calculation:

      - The number of patients for inclusion was calculated with regard to the primary criterion
      for evaluation (the percentage of patients receiving a prescription of HDM SLIT) and its 95%
      confidence interval (CI). For a frequency of 50%, it was calculated that the estimation of a
      95%CI with a precision of 5% would require the inclusion of 1537 participants with valid
      datasets. Taking into account a probable missing data rate of 5%, the recruitment target was
      set to n=1600 patients, with up to 8 consecutive patients recruited by 200 active
      investigating physicians.

      The study's logistic aspects and data management were handled by a contract research
      organization (CRO, Monitoring Force France SAS, Maisons-Laffitte, France).

      Evaluation criteria:

        1. Efficacy parameters

        2. Safety parameters

        3. Other parameters:

             -  Number of allergic episodes

             -  Allergic Rhinitis Classification (according to ARIA)

             -  Asthma Control (according to GINA 2014)

             -  Diagnosed allergies

             -  Sensitization

             -  Treatment and follow-up
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Investigating physicians' population:

        The study was proposed to a representative sample of allergists and other specialist
        physicians.

        Patients' population:

        Each investigating physician could include in the cross-sectional analysis phase the 8
        first HDM-associated allergic patients (children and/or adolescents) who were coming by
        themselves to the physician's practice, meeting the selection criteria and agreeing to
        participate in the study.

        Patients who started a HDMs sublingual immuntherapy at the end of the inclusion visit were
        included in the longitudinal phase.