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Completed

NCT Number: NCT01868113

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

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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Key information

Age range

2 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Makerere University College of Health Sciences

Kampala, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inhaled corticosteroid

Drug

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

Other names: Inhaled fluticasone propionate

Placebo

Other

Placebo to be administered 12hourly

Other names: Inhaler propellant

Primary outcomes

  1. case fatality

    Time frame: In-hospital mortality

    Proportion of enrolled children who die of severe acute lower respiratory infection in the intervention compared to the placebo

Secondary outcomes

  1. Hospital stay

    Time frame: 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.

Other outcomes

  1. Health workers' attitudes and perceptions towards use of inhaled corticosteroids, Mothers/ caretakers' level of satisfaction with the treatment

    Time frame: study period

    Proportion of health workers who know how to treat ALRI in children, attitudes and perceptions towards use of inhaled corticosteroids Mothers/ caretakers' level of satisfaction with the treatment given during hospitalisation.

Sponsors and collaborators

Lead sponsor

Makerere University

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

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

Acronym: ICS

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 4, 2013
Registry last updated
Oct 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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