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

NCT03065920 | Completed DMC

• 1 other identifier: ASAP 001
• Study Type: observational
• Target: 1,676
• Locations: 4 countries
• Sites: 4

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.

Conditions

Severe Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Treatment Severe Asthma

  3 years

• Health Care Utilisation rates

  3 years

• Exacerbations

  3 years

• Mortality rates

  3 years

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All Asthma Patients presenting at study clinics who are between 12 and 70 years and older resident within 30km of the enrolling sites.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Makerere University: lead

Study Sites (4)

Black Lion Hospital

Addis Ababa, Central, Ethiopia

Location

Kenyatta National Hospital

Nairobi, Central, Kenya

Location

Groningen Research Institute for Asthma and COPD (GRIAC)

Amsterdam, Central, Netherlands

Location

Mulago Hospital

Kampala, Central Region, 7072, Uganda

Location

Related Publications (2)

• 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.

  PMID: 34048497 DERIVED

• 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.

  PMID: 32612738 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Bruce J Kirenga

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: February 28, 2017
• Study Start: April 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share

Locations

NL (1); KE (1); UG (1); ET (1)