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

Bacterial Pneumonia Clinical Trial

— ICS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01868113
• Other study ID #: HS1259
• Status: Completed
• Phase: Phase 3
• First received: May 30, 2013
• Last updated: October 25, 2015
• Start date: December 2012
• Est. completion date: January 2014

Study information

• Verified date: April 2015
• Source: Makerere University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: National Council for Science and TechnologyUganda: National Drug Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1010
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 59 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acute Asthma
• Bacterial Pneumonia
• Pneumonia
• Pneumonia, Bacterial
• Pneumonia, Viral
• Respiratory Tract Infections
• Viral Pneumonia

Intervention

Drug:
• Inhaled corticosteroid
Inhaled fluticasone 500mcg 12 hourly up to discharge or a maximum of 5 days

Other:
• Placebo
Placebo to be administered 12hourly

Locations

Country	Name	City	State
Uganda	Makerere University College of Health Sciences	Kampala

Sponsors (2)

Lead Sponsor	Collaborator
Makerere University	University of Copenhagen

Country where clinical trial is conducted

Uganda, 

References & Publications (5)

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. — View Citation

Okoromah CN, Oviawe O. Is childhood asthma underdiagnosed and undertreated? Niger Postgrad Med J. 2002 Dec;9(4):221-5. — View Citation

Østergaard 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. — View Citation

Østergaard 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health workers' attitudes and perceptions towards use of inhaled corticosteroids, Mothers/ caretakers' level of satisfaction with the treatment	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.	study period	No
Primary	case fatality	Proportion of enrolled children who die of severe acute lower respiratory infection in the intervention compared to the placebo	In-hospital mortality	Yes
Secondary	Hospital stay	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.	From admission to discharge	Yes

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