Respiratory
Conditions
Interventions
standard of care
Sponsors
Dr Pinkie Mekgwe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age for inclusion children and adolescents 6-18 years at the time of consent • Known asthmatic on treatment. • Newly diagnosed asthma based on investigator review and/or medical report. • All patients will have their asthma diagnosis confirmed (both new or known asthmatic patients) by either spirometry with reversibility or excessive diurnal variability by PEFR twice daily over 2 weeks. • Ability to perform Peak Expiratory Flow rate and/or bronchodilator reversibility testing. • Only participants with mild, or moderate asthma , based on medical history • At least one exacerbation of asthma in the past year as defined by an event requiring treatment with systemic corticosteroids for =3 days and/or a hospitalisation/emergency room visit for asthma requiring treatment with systemic corticosteroids. • Written consent from the participant or parent/guardian and assent from study participants where applicable. • Participant and/or parent/guardian agrees to comply with the study procedures, including the completion of the visits and be available for contact for telephonically for the non-contact visits.
Exclusion criteria
Exclusion criteria: • Tuberculosis (TB): active TB disease and contact with people with active TB disease in the last 6 months. • Chronic sputum expectoration, chest pain, shortness of breath, dizziness, or light-headedness in the last 2 months. • Cardiac arrythmia. • Chronic conditions: thyrotoxicosis, phaeochromocytoma, cardiovascular disease, severe hypertension. • Uncontrolled diabetes mellitus • Patients with Peak Expiratory Flow Rate < 50% of predicted , as these would be classified as severe asthmatics. • Patients with any history of life-threatening asthma, defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s). • Any use of biological therapy or immunomodulatory therapy such as methotrexate or regular oral prednisolone for the asthma management (STEP 5 GINA therapy). • Any surgical or medical condition that would significantly alter the absorption, distribution, metabolism or excretion of the IMP which may jeopardise the safety of the participants. The investigator should make this determination in consideration of the volunteer’s medical history. • Any physical, mental or social condition, laboratory abnormality of history of illness that in the investigator’s judgement might jeopardise the safety of the participant in the context of the study or might interfere with study procedures or the ability of the participant to adhere to and complete the study. The investigator should make this determination consideration of the volunteer’s medical history. • Inability to present for follow-up or leaving the study area within 12 months of enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of severe asthma exacerbations in the treatment year, defined as “events requiring systemic corticosteroids for three or more days and/or a hospitalisation/emergency room visit for asthma requiring systemic corticosteroids.” | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Endpoints • Asthma Control Test (ACT) for = 12 years or Childhood ACT (cACT) for children 6-11 years. • Paediatric Asthma Quality of Life Questionnaire (PAQLQ) • Peak Expiratory Flow Rate • School or work absence for carers/guardians • Adverse events (AE) • Serious Adverse Events (SAEs). Health economics Endpoints (N=200 participants) • Quality of survival estimates: time to first exacerbation, health- related quality of life using validated generic preference-based measures of health (EQ-5D-Y), adverse effects, school, work, household labour absences. • Household-level economic impact by socio-economic stratum (World Bank approach): out-of-pocket expenditures, loss of household productivity time and income (productivity losses), borrowing, and education losses. • Health system: health care costs related to in/out patient treatment of both the usual care and the intervention, including overhead costs, as well as cost savings from reduced exacerbations due to intervention and cost per quality-adjusted | — |
Countries
South Africa
Contacts
Public ContactSbekezelo Hlophe
PhD Student
Outcome results
None listed