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

NCT ID: NCT01008761

Last Updated: 2012-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Keywords

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Pre-school child Wheezy episode

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Zithromax, 100 mgmgs; 5mls suspension

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)

Group Type ACTIVE_COMPARATOR

Azithromycin

Intervention Type DRUG

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)

Suspension placebo,

placebo (suspension produced by CDC Edmonton.) given at 10 mg/kg/day for day 1, then 5 mg/kg for 4 days.

Group Type PLACEBO_COMPARATOR

Suspension Placebo

Intervention Type DRUG

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

Interventions

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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)

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Azithromycin, zithromax, macrolide Azithromycin

Eligibility Criteria

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Inclusion Criteria

* 12-60 months
* wheeze on auscultation

Exclusion Criteria

* antibiotic use in the past 30 days
* macrolide allergy
* underlying medical condition
* significant co-morbidities
* current enrollment
* language barrier or no access to phone for follow up
Minimum Eligible Age

12 Months

Maximum Eligible Age

60 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role collaborator

Janielee Williamson

OTHER

Sponsor Role lead

Responsible Party

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Janielee Williamson

CCCRP Research Coordinator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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David W Johnson, MD

Role: PRINCIPAL_INVESTIGATOR

Alberta children's Hospital/University of Calgary

Piush Mandhane, MD

Role: PRINCIPAL_INVESTIGATOR

Stollery Children's Hospital Edmonton

Locations

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Alberta Children's Hospital

Calgary, Alberta, Canada

Site Status RECRUITING

Stollery Children's Hospital

Edmonton, Alberta, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Janielee Williamson, RN

Role: CONTACT

Phone: 403-955-3186

Email: [email protected]

David W. Johnson, MD

Role: CONTACT

Phone: 403-955-7507

Email: [email protected]

Facility Contacts

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Janielee Williamson, RN

Role: primary

Paula Finnson

Role: backup

Piush Mandhane, MD

Role: primary

Other Identifiers

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ALAWhZy2010

Identifier Type: -

Identifier Source: org_study_id