Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-03-02 @ 4:09 AM
Study NCT ID:
NCT03065920
Status:
COMPLETED
Last Update Posted:
2023-05-31
First Post:
2016-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
African Severe Asthma Program: A Research Network for Characterisation of Severe Asthma in Africans (ASAP)
Sponsor:
Makerere University
Organization:
Study Overview
Official Title:
African Severe Asthma Program
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASAP
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: