Pediatric Study to Evaluate Treatment of Persistent Moderate or Severe Asthma With the Association Fluticasone 250 mcg/Dose and Salmeterol 50 mcg/Dose - ADERE PROJECT
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Prospective, parallel-group, randomized study to evaluate the compliance to the treatment of
      children aged between 6 and 14 years old with persistent moderate or severe asthma, receiving
      the association Fluticasone 250 mcg/dose and Salmeterol 50 mcg/dose twice a day.

      ADERE PROJECT (Pediatric)
    

Detailed description: 
      Objectives

      General:

      To evaluate the compliance degree to the treatment of asthmatic children, according to the
      attention received.

      Specific:

        1. To study asthmatic compliance to the treatment proposed, aiming at an association with
           other factors, such as: parents' instruction, hospitalizations, personal and family
           history of atopy, co-morbidities, severity of the disease and use of other drugs.

        2. To study asthmatic compliance to the treatment proposed, associating it with the impact
           in quality of life, though the application of a specific questionnaire.

      Outcomes

      The main outcome, compliance, is being measured by the number of doses used of the drug
      salmeterol combined with fluticasone (Seretide Diskus) divided by the number of doses
      foreseen for the time considered.

      The following will be considered as secondary outcomes:

        -  Disease control, evaluated by information in the questionnaires.

        -  Regular medical attention sought, evaluated by information in the questionnaires.

        -  Additional resources in the event of attacks, increase in the weekly number of nocturnal
           awakening or the number of awakenings per night, increase in the use of rescue drug.

        -  Improvement in the quality of life.

      Casuistic and Method

      Study groups

      Asthmatic children aged 6 to 14 years old from both sexes, with persistent mild, moderate or
      sever asthma classified according to the criteria from the III - Brazilian Consensus on
      Asthma Management.

      Group I - Asthmatic children being treated, who will be given medical guidance and
      therapeutic guidance through telephone calls at every fifteen days to the parents or
      guardians, performed by trained professionals.

      Group II - Asthmatic children being treated, who will be given medical guidance without
      telephone follow-up calls to parents or guardians.

      Study Design

      This is a prospective, controlled, randomized, parallel-group study, with the inclusion of
      472 children presenting persistent moderate or severe asthma. Our researchers developed the
      study, and it will be performed only in Brazil, solely by our Clinical Research Center. The
      drug to be used is in accordance with the main International Consensus on Asthma Treatment
      and with the III - Brazilian Consensus on Asthma Management, being marketed for some years in
      Brazil.

      During patient recruitment and screening, their parents or guardians will fill out the free
      informed consent form. At this time, they will also be given the drug (Seretide Diskus®
      50/250) with doses enough for a 90-day treatment, twice a day, in addition to instructions on
      the use of the device to apply the drug and guidance from his/her physician on how to act in
      the event of an attack.

      After study inclusion, the study will receive a number which will randomly include him/her in
      group 1 or 2 of this study.

      Patients included in group 1 will receive two types of telephone calls:

      A. Investigation telephone call - TI: that will be made by a trained health professional from
      the Centro de Pesquisa Clínica e Medicina Avançada, aiming at: presentation, data collection
      on asthma, including demographics and relevant clinical history (details on asthma, previous
      exacerbations, drugs used, etc), submission of a standardized checking questionnaire
      (questionnaire 1 - attachment 1) and quality of life questionnaire (questionnaire 2 -
      attachment 2). By 90 days, the patient's guardian will receive the last investigation
      telephone call (TI -2) in order to apply the quality of life questionnaire and standardized
      evaluation questionnaire (questionnaire 1 - attachment 1)

      B. Compliance telephone call - TA: A specifically trained professional will make follow-up
      telephone calls at every fifteen days, according to a pre-established guide (Attachment 4),
      requesting the patient to answer the questions pursuant to the follow-up questionnaire
      (attachment 3) and clarifying probable doubts on the drug application, however, without
      interfering with the treatment prescribed by the physician.

      Patients included in group 2 will receive only the Investigation Telephone call (TI) All
      telephone contacts will be made for the same person: mother, father or guardian.

      By the end of week 12, the persons responsible for the patients will return, by mail, the
      drug to Centro de Pesquisa Clínica e Medicina Avançada.
    

Intervention name(s): Telephone follow-up; No telephone follow-up
Intervention type(s): Other; Other
Intervention description(s): Asthmatic children being treated, who will be given medical guidance and therapeutic guidance through telephone calls at every fifteen days to the parents or guardians, performed by trained professionals.; Asthmatic children being treated, who will be given medical guidance without telephone follow-up calls to parents or guardians.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment compliance; Pediatric; Asthma