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

Phase 3

Completed

• Conditions: Acute Asthma; Bacterial Pneumonia; Viral Pneumonia
• Interventions: Other: Placebo; Drug: Inhaled corticosteroid

• Registration Number: NCT01868113
• Lead Sponsor: Makerere University

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-05-30
• Study First Submitted QC: 2013-05-30
• Study First Posted: 2013-06-04
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-04
• Last Update Submitted: 2015-10-25
• Last Update Posted: 2015-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1010

Inclusion Criteria

• children aged 2 to 59 months with cough and or difficult breathing

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inhaler propellant	Placebo	Placebo
Inhaled fluticasone propionate	Inhaled corticosteroid	Inhaled corticosteroid

Primary Outcome Measures

Name	Time	Method
case fatality	In-hospital mortality	Proportion of enrolled children who die of severe acute lower respiratory infection in the intervention compared to the placebo

Secondary Outcome Measures

Name	Time	Method
Hospital stay	From admission to discharge	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.

Trial Locations

Locations (1)

Makerere University College of Health Sciences; 🇺🇬 Kampala, Uganda