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

Makerere University

Status and phase: Completed; Phase 3

Conditions: Bacterial Pneumonia; Acute Asthma; Viral Pneumonia

Treatments: Drug: Inhaled corticosteroid; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01868113

HS1259

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,010 patients

Sex: All

Ages: 2 to 59 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,010 participants in 2 patient groups, including a placebo group

Inhaled fluticasone propionate

Active Comparator group

Description:

Inhaled corticosteroid

Treatment:

Drug: Inhaled corticosteroid

Inhaler propellant

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo