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Trial for the Treatment of Acute Asthma in Wheezy Pre-school Aged Children

NCT01008761 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2012-07-12

No results posted yet for this study

Summary

To determine if treatment of pre-school children with a history of wheeze who present to an Emergency Department with an acute wheezing episode with azithromycin for 5 days will resolve their symptoms more quickly, will require less short acting beta agonist (SABA), and allow these children to remain symptom free for a longer period of time.

Conditions

Interventions

DRUG

Azithromycin

Azithromycin given at 10 mg/kg/day for day 1, then 5 mg/kg for 4 days Each syringe will contain 12.5 mls (250 mgs) sufficient drug to adequately dose children who with up to 25 kgs (95%tile for weight for 60 month old child)

DRUG

Suspension Placebo

Placebo suspension will be administered on day 1 at 10mg/kg and then for the next 4 days at 5 mg/kg

Sponsors & Collaborators

  • University of Alberta

    collaborator OTHER

  • Janielee Williamson

    lead OTHER

Principal Investigators

  • David W Johnson, MD · Alberta children's Hospital/University of Calgary

  • Piush Mandhane, MD · Stollery Children's Hospital Edmonton

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
60 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-12-31
Completion
2013-12-31

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases

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 NCT01008761 on ClinicalTrials.gov