Official Title
African Severe Asthma Program
Brief Title
African Severe Asthma Program: A Research Network for Characterisation of Severe Asthma in Africans (ASAP)
Protocol ID
NCT03065920
Lead Sponsor
Makerere University
Brief 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.
Enrollment Count
1,676 participants
Eligibility Criteria
Inclusion Criteria:
- All Asthma Patients presenting at study clinics who are between 12 and 70 years and
older resident within 30km of the enrolling sites.
Exclusion Criteria:
- Asthma patients with contra-indications to any of the study procedures and tests.
In addition the following patients will be excluded:
- Patients with a primary diagnosis of an alternative lung disease (e.g.: COPD, or
bronchiectasis, pulmonary fibrosis.),
- Patients with another significant disease likely to confound assessment of asthma
(e.g: active tuberculosis),
- Patients unable to perform study tests and procedures,
- Patients over 70 years of age, patients who have been exposed to experimental
treatments within the past three months
- Pregnant women.
Filters
Severe Asthma
COMPLETED
CHILD
ADULT
OLDER_ADULT