Enhanced versus standard outpatient care of asthmatic children in Malawi: study protocol for a pilot randomised controlled trial

BackgroundAsthma is the most common chronic disease in childhood and is a growing global concern. However, there are limited data regarding long-term asthma management in low-income countries (LIC), particularly for children. This study will assess the feasibility of recruitment and retention, the acceptability of an intervention and data collection methods, and baseline levels of asthma control and exacerbation rates in our target population of Malawian asthmatic children. Furthermore, we plan to; evaluate the effect of a package of enhanced asthma care, appropriate for a LIC, over a 3-month period; to describe clinical and airway inflammatory phenotypes; to identify clinical and laboratory features which might predict response to treatment in this population. MethodsWe will recruit 120 children aged 6-15 years, attending outpatient asthma follow-up at a tertiary government hospital in Malawi. Participants will be randomised, stratified by level of asthma control (Childhood Asthma Control Test (C-ACT) [≤]19 or [≥]20), to receive standard care in the hospital clinic, or an enhanced care package comprising; detailed clinical assessment (including pre- and post-bronchodilator spirometry, exercise challenge, exhaled nitric oxide (FeNO) measurement and sputum induction), optimisation of inhaled asthma treatment, and asthma education delivered by non-healthcare workers. Feasibility outcomes will include recruitment and retention rates, data completeness for study procedures, and baseline asthma control and exacerbation rates. The primary clinical outcome is asthma control, measured by C-ACT at 3 months, with adjustment for baseline measurement and intervention as covariates in a regression model. Secondary clinical outcomes at 3 months include; asthma exacerbations (requiring emergency health care use, treatment with oral corticosteroids or hospital admission), school absence, lung function and FeNO levels. Participants will be described by clinical and inflammatory phenotypes, with the latter categorised as eosinophilic or non-eosinophilic based on sputum cytology results and FeNO levels. DiscussionIt is important to assess whether global treatment guidelines for long-term asthma management are appropriate for low-income settings. This study will provide key feasibility data, including baseline clinical characteristics of asthmatic Malawian children, to inform assessment of an asthma care package in a low-income setting, which includes task-shifting to non-healthcare workers. Trial registrationPan African Clinical Trials Registry: PACTR201807211617031. Registered 09/07/18, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3468