Calling time on avoidable morbidity from asthma in African children

Research question In a poor rural population in KwaZulu-Natal using a pragmatic adaptive randomised controlled trial in 2028 children and adolescents to answer the questions: a) Is a combination inhaled steroid/ fast onset long acting β2 agonist (ICS/LABA) clinically effective? b) Is the ICS/LABA cost-effective compared to standard of care as per South African Asthma Guidelines?

I will establish an observatory for asthma in adolescents in Africa by answering the following questions: a) What is the prevalence and what are the risk factors for asthma in children and adolescents in Africa? Background In Africa, over 50 million children suffer from asthma.

Mortality is unacceptably high and far exceeds that seen in high income regions of the world - for example the rate of asthma deaths is as high as 100 times that in the UK.

A major contributor to the high and largely preventable morbidity and mortality from asthma in Africa is lack of access to effective and affordable inhaled therapies.

Even the very first step of asthma treatment as recommended by the Global Initiative for Asthma -h; inhaled corticosteroid/fast onset β2 agonist (ICS/LABA) as required -h; is out of reach for the great majority in Africa.

This global inequality has been ignored for too long due to a lack of high-quality burden of disease data and robust clinical and health economic data to guide policy.

Aims and objectives To determine the clinical and cost effectiveness of ICS/LABA compared to standard asthma care The determine the prevalence and risk factors for asthma in adolescents in Africa To create an observatory for asthma for Africa To establish opportunities for early career researcher in Africa to strengthen research capacity To advocate for access and effective medications for asthma for African children and adolescents.Design and methods a) Individually randomised controlled adaptive trial of a single inhaler-based approach to asthma management.

Population: Children and adolescents 6 -18-years, with ≥1 asthma exacerbation in the preceding 12 months.Intervention: A pragmatic strategy using an (ICS/LABA) inhaler for asthma exacerbations as well as for maintenance treatment.

Control: Standard care for asthma.Primary outcome: Severe asthma exacerbations defined as events requiring treatment with systemic corticosteroids (oral or intravenous).Time: 12 months' follow-up. b) Multi-country cross-sectional study of three African countries to determine the prevalence and risk factors for asthma using standardised methodology from the Global Asthma Network (GAN) using self-administered written and video questionnaires.

Additional questions on risk factors adapted to the African context will be included.

Timelines: I propose to have relevant approvals/engagements (12 months), data collection (42 months), data analysis (48 months) and reporting/dissemination (60 months).

Outputs and dissemination Effective and accessible asthma treatment Creation of an asthma observatory to improve the care of children and adolescents with asthma Masters and PhD opportunities for early career researchers Community engagement, publications and policy briefs Dissemination through Pan African Thoracic Society, Global Asthma Network and the International Union of Tuberculosis and Lung Disease through WHO engagement for access to affordable asthma therapy for all