African Severe Asthma Program: A Research Network for Characterisation of Severe Asthma in Africans (ASAP)

Severe Asthma Clinical Trial

— ASAP  

Official title:

African Severe Asthma Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03065920
• Other study ID #: ASAP 001
• Status: Completed
• Start date: April 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2023
• Source: Makerere University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1676
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Severe Asthma

Locations

Country	Name	City	State
Ethiopia	Black Lion Hospital	Addis Ababa	Central
Kenya	Kenyatta National Hospital	Nairobi	Central
Netherlands	Groningen Research Institute for Asthma and COPD (GRIAC)	Amsterdam	Central
Uganda	Mulago Hospital	Kampala	Central

Sponsors (1)

Lead Sponsor	Collaborator
Makerere University

Countries where clinical trial is conducted

Ethiopia,  Kenya,  Netherlands,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with Severe Asthma.	The primary end point in this study is severe asthma. We shall document the proportion of the enrolled patients that have severe asthma and perform a factor analysis to identify factors independently associated with severe asthma.	3 years
Secondary	Treatment Severe Asthma	Incidences rates of this outcome between groups (severe and not severe asthma) will be compared and predictors of this outcome analysed.	3 years
Secondary	Health Care Utilisation rates	Incidences rates of this outcome between groups (severe and not severe asthma) will be compared and predictors of this outcome analysed.	3 years
Secondary	Exacerbations	Incidences rates of this outcome between groups (severe and not severe asthma) will be compared and predictors of this outcome analysed.	3 years
Secondary	Mortality rates	Incidences rates of this outcome between groups (severe and not severe asthma) will be compared and predictors of this outcome analysed.	3 years