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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Makerere University
University of Copenhagen
Information provided by (Responsible Party):
Makerere University Identifier:
First received: May 30, 2013
Last updated: NA
Last verified: April 2013
History: No changes posted

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 Intervention Phase
Bacterial Pneumonia
Viral Pneumonia
Acute Asthma
Drug: Inhaled corticosteroid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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

Resource links provided by NLM:

Further study details as provided by Makerere University:

Primary Outcome Measures:
  • case fatality [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Proportion of children with severe acute lower respiratory infection who die during the study period

Secondary Outcome Measures:
  • Hospital stay [ Time Frame: From admission to discharge ] [ Designated as safety issue: No ]
    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:
  • Health workers' attitudes and perceptions towards use of inhaled corticosteroids, Mothers/ caretakers' level of satisfaction with the treatment [ Time Frame: study period ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 1400
Study Start Date: December 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   2 Months to 59 Months
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01868113

Contact: Grace Ndeezi, PhD +256772453191
Contact: James K Tumwine, PhD +256772494120

Makerere University College of Health Sciences Recruiting
Kampala, Uganda
Contact: Grace Ndeezi, PhD    +256772453191   
Contact: James K Tumwine, PhD    +256772494120   
Principal Investigator: Grace Ndeezi, PhD         
Sub-Investigator: James K Tumwine, PhD         
Sub-Investigator: Marianne S Østergaard, PhD         
Sponsors and Collaborators
Makerere University
University of Copenhagen
Principal Investigator: Grace Ndeezi, PhD Makerere University
Study Chair: Marianne S Østergaard, PhD University of Copenhagen
Study Director: James K Tumwine, PhD Makerere University
  More Information

Additional Information:
PUBMED  This link exits the site

Responsible Party: Makerere University Identifier: NCT01868113     History of Changes
Other Study ID Numbers: HS1259
Study First Received: May 30, 2013
Last Updated: May 30, 2013
Health Authority: Uganda: National Council for Science and Technology
Uganda: National Drug Authority

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

Additional relevant MeSH terms:
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses processed this record on February 27, 2015