Inhaled Corticosteroids in U-5 Children With Acute Respiratory Infection in Uganda: A Randomised Trial

Study Overview
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Brief Summary
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The purpose of this study is to find out whether adjunct treatment with inhaled corticosteroids lead to faster improvement and reduce mortality of children under 5 years of age admitted to hospital with ALRI.

Detailed Description
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Pneumonia is one of the common causes of serious illness in children under 5 years of age. It is one of the common causes of admission to hospital and the commonest cause of death in Ugandan children under 5 years of age. The signs of pneumonia also occur in children with asthma making it difficult to differentiate the two. Other researchers have found that one of two children under five years of age with pneumonia have asthma. Wheeze which is regarded as a sign of asthma is heard in only one of three children with asthma, implying that many children with asthma especially in the first few years of life are less likely to be diagnosed. They are also less likely to receive inhaled steroids, the recommended treatment for asthma. Failure to administer asthma medicines may contribute to delayed improvement and increase the risk of death. The study hypothesizes that use of inhaled corticosteroids in addition to standard treatment in children hospitalized with ALRI will be associated with reduced morbidity and mortality and that the improvement will be more marked in children diagnosed with asthma posthoc. Outcomes: Reduction in case fatality, Time to normalization of respiratory rate, Time to normalization of oxygen saturation, Duration of hospitalisation.

Official Title
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Acute Respiratory Infections and Asthma in U-5 Children: Improved Treatment to Reduce Morbidity and Mortality in Uganda, A Randomized Controlled Trial

Conditions
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Bacterial Pneumonia, Viral Pneumonia, Acute Asthma

Intervention / Treatment
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* Drug: Inhaled corticosteroid
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children aged 2 to 59 months with cough and or difficult breathing Exclusion Criteria: Presence of a serious concurrent illness such as meningitis, Children with congenital or acquired heart disease Severe anaemia Measles pneumonia Foreign body inhalation A confirmed diagnosis of pulmonary tuberculosis

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Inhaled fluticasone propionate<br>Inhaled corticosteroid | Drug: Inhaled corticosteroid<br>* Inhaled fluticasone 500mcg 12 hourly up to discharge or a maximum of 5 days<br>* Other names: Inhaled fluticasone propionate;|
| Placebo Comparator: Inhaler propellant<br>Placebo | Other: Placebo<br>* Placebo to be administered 12hourly<br>* Other names: Inhaler propellant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| case fatality | Proportion of enrolled children who die of severe acute lower respiratory infection in the intervention compared to the placebo | In-hospital mortality | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay | The average duration of hospitalisation in the intervention compared to the placebo group. The average duration of hospitalisation in the pneumonia compared to the children with asthma per treatment arm. | From admission to discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children U-5, ALRI, Inhaled Corticosteroids