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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1010 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-01-31

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.

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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.

Conditions

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Bacterial Pneumonia Viral Pneumonia Acute Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Inhaled fluticasone propionate

Inhaled corticosteroid

Group Type ACTIVE_COMPARATOR

Inhaled corticosteroid

Intervention Type DRUG

Inhaled fluticasone 500mcg 12 hourly up to discharge or a maximum of 5 days

Inhaler propellant

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo to be administered 12hourly

Interventions

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