Clinical trial NCT01868113: Inhaled Corticosteroids in U-5 Children With Acute Respiratory Infection in Uganda: A Randomised Trial
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Pneumonia
Viral Pneumonia
Acute Asthma
Keywords: Children U-5
ALRI
Inhaled Corticosteroids
Lead sponsor: Makerere University
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2013-06-04
Enrollment: 1010
Sex: ALL
Minimum age (years): 2
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: case fatality
timeFrame: In-hospital mortality
Secondary outcomes:
measure: Hospital stay
timeFrame: From admission to discharge
Other outcomes:
measure: Health workers' attitudes and perceptions towards use of inhaled corticosteroids, Mothers/ caretakers' level of satisfaction with the treatment
timeFrame: study period
Locations:
city: Kampala
country: Uganda
facility: Makerere University College of Health Sciences
Study officials:
affiliation: Makerere University
name: Grace Ndeezi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Copenhagen
name: Marianne S Østergaard, PhD
role: STUDY_CHAIR
affiliation: Makerere University
name: James K Tumwine, PhD
role: STUDY_DIRECTOR
References:
citation: Ostergaard MS, Nantanda R, Tumwine JK, Aabenhus R. Childhood asthma in low income countries: an invisible killer? Prim Care Respir J. 2012 Jun;21(2):214-9. doi: 10.4104/pcrj.2012.00038.
citation: Ostergaard MS, Prahl P. Diagnosis of preschool asthma: parents' comments and typical phrases may ease history-taking. Prim Care Respir J. 2007 Jun;16(3):194-5. doi: 10.3132/pcrj.2007.00035. No abstract available.
citation: Sachdev HP, Mahajan SC, Garg A. Improving antibiotic and bronchodilator prescription in children presenting with difficult breathing: experience from an urban hospital in India. Indian Pediatr. 2001 Aug;38(8):827-38.
citation: Okoromah CN, Oviawe O. Is childhood asthma underdiagnosed and undertreated? Niger Postgrad Med J. 2002 Dec;9(4):221-5.
citation: Nantanda R, Hildenwall H, Peterson S, Kaddu-Mulindwa D, Kalyesubula I, Tumwine JK. Bacterial aetiology and outcome in children with severe pneumonia in Uganda. Ann Trop Paediatr. 2008 Dec;28(4):253-60. doi: 10.1179/146532808X375404.