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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01868113
Recruitment Status : Completed
First Posted : June 4, 2013
Last Update Posted : October 27, 2015
University of Copenhagen
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bacterial Pneumonia Viral Pneumonia Acute Asthma Drug: Inhaled corticosteroid Other: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1010 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Acute Respiratory Infections and Asthma in U-5 Children: Improved Treatment to Reduce Morbidity and Mortality in Uganda, A Randomized Controlled Trial
Study Start Date : December 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids

Arm Intervention/treatment
Active Comparator: Inhaled fluticasone propionate
Inhaled corticosteroid
Drug: Inhaled corticosteroid
Inhaled fluticasone 500mcg 12 hourly up to discharge or a maximum of 5 days
Other Name: Inhaled fluticasone propionate

Placebo Comparator: Inhaler propellant
Other: Placebo
Placebo to be administered 12hourly
Other Name: Inhaler propellant

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.

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Ages Eligible for Study:   2 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01868113

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Makerere University College of Health Sciences
Kampala, Uganda
Sponsors and Collaborators
Makerere University
University of Copenhagen
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Principal Investigator: Grace Ndeezi, PhD Makerere University
Study Chair: Marianne S Østergaard, PhD University of Copenhagen
Study Director: James K Tumwine, PhD Makerere University

Additional Information:
PUBMED  This link exits the site

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Responsible Party: Makerere University Identifier: NCT01868113     History of Changes
Other Study ID Numbers: HS1259
First Posted: June 4, 2013    Key Record Dates
Last Update Posted: October 27, 2015
Last Verified: April 2015

Keywords provided by Makerere University:
Children U-5
Inhaled Corticosteroids

Additional relevant MeSH terms:
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Respiratory Tract Infections
Pneumonia, Bacterial
Pneumonia, Viral
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Bacterial Infections
Virus Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents