African Severe Asthma Program: A Research Network for Characterisation of Severe Asthma in Africans (ASAP)
Condition: Severe Asthma
MeSH terms: Asthma
Study type: Observational [Patient Registry]

Summary: 
      This study is a prospective observational multicentre cohort study of asthma patients in
      Eastern Africa whose objectives will be; The primary objective of this project is to identify
      and characterize severe asthma in Eastern Africa in order to understand its demographic,
      clinical, physiologic, pathologic, genomic and immunologic determinants.

      Secondary objective(s) are; Compare the annual healthcare utilisation (HCU) (emergency room
      visits, hospitalization including admission to critical care units and unscheduled outpatient
      clinic or office visits), exacerbation, quality of life and mortality rates of severe and
      not- severe asthma patients Determine the factors associated with the asthma HCU events,
      quality of life, exacerbations and mortality The study will enroll 1676 patients aged between
      12 and 70 years and follow up each patient for up to one year.
    

Detailed description: 
      This study is a prospective observational multicentre cohort study of asthma patients in
      Eastern Africa. whose objectives will be; The primary objective of this project is to
      identify and characterize severe asthma in Eastern Africa in order to understand its
      demographic, clinical, physiologic, pathologic, genomic and immunologic determinants.

      Secondary objective(s) are; Compare the annual healthcare utilisation (HCU) (emergency room
      visits, hospitalization including admission to critical care units and unscheduled outpatient
      clinic or office visits), exacerbation, quality of life and mortality rates of severe and
      not- severe asthma patients Determine the factors associated with the asthma HCU events,
      quality of life, exacerbations and mortality.

      The study will enroll 1676 patients aged between 12 and 70 years and follow up each patient
      for up to one year.

      Measurements; The following will be done

        -  Asthma Diagnosis. This will be done and will be an entry point to the study. It will be
           done to ensure patients enrolled onto the study fulfill a clinical diagnosis of Asthma.

        -  Cohort Characterisation. Through use of a predeveloped clinical review form, data on
           demographics, symptoms, exposures to pollutants, known asthma triggers, tobacco smoking,
           psychosocial issues, comorbidities, asthma control, adherence to medication and inhaler
           technique will be collected. Asthma quality of life will also be ascertained through use
           of a questionnaire.

      Further measurements to characterise asthma will be performed and include;

        -  Spirometry

        -  Bronchial hyperresponsiveness testing using methacholine challenge tests

        -  Skin prick test (SPT), total IgE assays and complete blood count (for eosinophils)

        -  FeNO for airway inflammation according to published guidelines.

        -  Stool microscopy for helminths infestation

        -  Replicative single nucleotide polymorphisms (SNP) genotying

        -  HIV testing Each patient will be followed up at intervals (initially monthly for 6
           months and then at month 9 and 12). At each clinic visit, treatment will be optimised.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All Asthma Patients presenting at study clinics during the study period. These will have to
        be 12 years and older resident within 30km radius 'of the enrolling sites.

        Asthma will be defined as either doctor diagnosed, clinical/treated asthma and
        wheezing/whistling breath in the last 12 months as used in the World Health Survey and
        other surveys.
      
Biospecimen description: 
      Replicative single nucleotide polymorphisms (SNP) genotying: Subjects enrolled into the study
      will be invited to participate in genetic research by providing a blood sample.

      DNA will be extracted from the blood samples.Part of the DNA will be used for replicative
      severe asthma associated SNPs genotying of SNPs previously reported to be associated with
      severe asthma. The remaining samples will be biobanked for future genetic and pharmacogenetic
      studies.