NCT01868113

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,010 (actual)
• Sponsor: Makerere University · Academic / Other
• Sex: All
• Age: 2 Months – 59 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Bacterial Pneumonia
• Viral Pneumonia
• Acute Asthma

Interventions

Type	Name	Description
DRUG	Inhaled corticosteroid	Inhaled fluticasone 500mcg 12 hourly up to discharge or a maximum of 5 days
OTHER	Placebo	Placebo to be administered 12hourly

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2013-06-04
• Last updated: 2015-10-27

Locations

1 site across 1 country: Uganda