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

NCT01868113 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1010

Last updated 2015-10-27

No results posted yet for this study

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.

Conditions

  • Bacterial Pneumonia
  • Viral Pneumonia
  • Acute Asthma

Interventions

DRUG

Inhaled corticosteroid

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

OTHER

Placebo

Placebo to be administered 12hourly

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER

  • Makerere University

    lead OTHER

Principal Investigators

  • Grace Ndeezi, PhD · Makerere University

  • Marianne S Østergaard, PhD · University of Copenhagen

  • James K Tumwine, PhD · Makerere University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01868113 on ClinicalTrials.gov