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

NCT ID: NCT03065920

Last Updated: 2023-05-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1676 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-12-31

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.

Conditions

Severe Asthma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Makerere University

OTHER

Sponsor Role: lead

Responsible Party

Bruce J Kirenga

Dr Bruce J Kirenga

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Black Lion Hospital

Addis Ababa, Central, Ethiopia

Kenyatta National Hospital

Nairobi, Central, Kenya

Groningen Research Institute for Asthma and COPD (GRIAC)

Amsterdam, Central, Netherlands

Mulago Hospital

Kampala, Central Region, Uganda

Countries

Ethiopia; Kenya; Netherlands; Uganda

References

Kwizera R, Bongomin F, Olum R, Worodria W, Bwanga F, Meya DB, Kirenga BJ, Gore R, Denning DW, Fowler SJ. Evaluation of an Aspergillus IgG/IgM lateral flow assay for serodiagnosis of fungal asthma in Uganda. PLoS One. 2021 May 28;16(5):e0252553. doi: 10.1371/journal.pone.0252553. eCollection 2021.

Reference Type: DERIVED

PMID: 34048497 (View on PubMed)

Kwizera R, Wadda V, Mugenyi L, Aanyu-Tukamuhebwa H, Nyale G, Yimer G, Chakaya J, De Jong C, Van der Molen T, Denning DW, Gore R, Kirenga BJ. Skin prick reactivity among asthmatics in East Africa. World Allergy Organ J. 2020 Jun 23;13(6):100130. doi: 10.1016/j.waojou.2020.100130. eCollection 2020 Jun.

Reference Type: DERIVED

PMID: 32612738 (View on PubMed)

Other Identifiers

ASAP 001

Identifier Type: -

Identifier Source: org_study_id