NCT01868113

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,010

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 4, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

October 27, 2015

Status Verified

April 1, 2015

Enrollment Period

1.1 years

First QC Date

May 30, 2013

Last Update Submit

October 25, 2015

Conditions

Bacterial PneumoniaViral PneumoniaAcute Asthma

Keywords

Children U-5ALRIInhaled Corticosteroids

Outcome Measures

Primary Outcomes (1)

  • case fatality

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

    In-hospital mortality

Secondary Outcomes (1)

  • Hospital stay

    From admission to discharge

Other Outcomes (1)

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

    study period

Study Arms (2)

Inhaled fluticasone propionate

ACTIVE COMPARATOR

Inhaled corticosteroid

Drug: Inhaled corticosteroid

Inhaler propellant

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Inhaled corticosteroidDRUG

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

Also known as: Inhaled fluticasone propionate
Inhaled fluticasone propionate
PlaceboOTHER

Placebo to be administered 12hourly

Also known as: Inhaler propellant
Inhaler propellant

Eligibility Criteria

Age2 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children aged 2 to 59 months with cough and or difficult breathing

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Makerere University College of Health Sciences

Kampala, Uganda

Location

Related Publications (5)

  • 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.

    PMID: 22623048BACKGROUND

  • 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.

    PMID: 17530145BACKGROUND

  • 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.

    PMID: 11520993BACKGROUND

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

    PMID: 12690683BACKGROUND

  • 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.

    PMID: 19021940BACKGROUND

Related Links

MeSH Terms

Conditions

Pneumonia, BacterialPneumonia, Viral

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesVirus Diseases

Study Officials

  • Grace Ndeezi, PhD

    Makerere University

    PRINCIPAL INVESTIGATOR

  • Marianne S Østergaard, PhD

    University of Copenhagen

    STUDY CHAIR

  • James K Tumwine, PhD

    Makerere University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2013

First Posted

June 4, 2013

Study Start

December 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

October 27, 2015

Record last verified: 2015-04

Locations

UG(1)