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

Primary Purpose

Asthma

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Azithromycin
Suspension Placebo
Sponsored by
Janielee Williamson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Pre-school child, Wheezy episode

Eligibility Criteria

12 Months - 60 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alberta Children's HospitalRecruiting
  • Stollery Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Zithromax, 100 mgmgs; 5mls suspension

Suspension placebo,

Arm Description

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)

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

Outcomes

Primary Outcome Measures

To determine if treatment of pre-school children with a history of wheeze who present to an Emergency department (ED) with an acute wheezing episode with Azithromycin for 5 days will resolve their symptoms more quickly

Secondary Outcome Measures

Treatment of pre-school children with acute wheezing symptoms with 5 days of azithromycin will cause these children to use less rescue beta2 agonists than those treated with placebo
Treatment of pre-school children with acute wheezing symptoms with 5 days of azithromycin will allow these children to remain free of subsequent wheezy episodes longer than those treated with placebo.

Full Information

First Posted
November 4, 2009
Last Updated
July 11, 2012
Sponsor
Janielee Williamson
Collaborators
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT01008761
Brief Title
Trial for the Treatment of Acute Asthma in Wheezy Pre-school Aged Children
Official Title
A Double Blind Randomized Control Trail of Azithromycin for the Acute Management of Wheezy Pre-school Children
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Janielee Williamson
Collaborators
University of Alberta

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Pre-school child, Wheezy episode

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Zithromax, 100 mgmgs; 5mls suspension
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Suspension placebo,
Arm Type
Placebo Comparator
Arm Description
placebo (suspension produced by CDC Edmonton.) given at 10 mg/kg/day for day 1, then 5 mg/kg for 4 days.
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Other Intervention Name(s)
Azithromycin, zithromax, macrolide
Intervention Description
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
Intervention Name(s)
Suspension Placebo
Other Intervention Name(s)
Azithromycin
Intervention Description
Placebo suspension will be administered on day 1 at 10mg/kg and then for the next 4 days at 5 mg/kg
Primary Outcome Measure Information:
Title
To determine if treatment of pre-school children with a history of wheeze who present to an Emergency department (ED) with an acute wheezing episode with Azithromycin for 5 days will resolve their symptoms more quickly
Time Frame
Patient is followed by phone day 1,3,5,7,14, with an in person return visit on day 21 and then by phone again every 2 weeks for 6 months
Secondary Outcome Measure Information:
Title
Treatment of pre-school children with acute wheezing symptoms with 5 days of azithromycin will cause these children to use less rescue beta2 agonists than those treated with placebo
Time Frame
Patient is followed by phone day 1,3,5,7,14, with an in person return visit on day 21 and then by phone again every 2 weeks for 6 months
Title
Treatment of pre-school children with acute wheezing symptoms with 5 days of azithromycin will allow these children to remain free of subsequent wheezy episodes longer than those treated with placebo.
Time Frame
Patient is followed by phone day 1,3,5,7,14, with an in person return visit on day 21 and then by phone again every 2 weeks for 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janielee Williamson, RN
Phone
403-955-3186
Email
janie.williamson@albertahealthservices.ca
First Name & Middle Initial & Last Name or Official Title & Degree
David W. Johnson, MD
Phone
403-955-7507
Email
david.johnson@alberthealthservices.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David W Johnson, MD
Organizational Affiliation
Alberta children's Hospital/University of Calgary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Piush Mandhane, MD
Organizational Affiliation
Stollery Children's Hospital Edmonton
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janielee Williamson, RN
Phone
403-955-3186
Email
janie.williamson@albertahealthservices.ca
First Name & Middle Initial & Last Name & Degree
Paula Finnson
Phone
403-955-7873
Email
paula.finnson@albertahealthservices.ca
First Name & Middle Initial & Last Name & Degree
David Johnson, MD
First Name & Middle Initial & Last Name & Degree
Sheldon Spier, MD
First Name & Middle Initial & Last Name & Degree
James D Kellner, MD
First Name & Middle Initial & Last Name & Degree
Candice Bjornson, MD
First Name & Middle Initial & Last Name & Degree
Michael Surrette, PhD
First Name & Middle Initial & Last Name & Degree
Alberto Nettle-Aguire, PhD
Facility Name
Stollery Children's Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2V7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piush Mandhane, MD
Email
piush.mandhane@albertahealthservices.ca
First Name & Middle Initial & Last Name & Degree
Piush Mandhane, MD
First Name & Middle Initial & Last Name & Degree
William Craig, MD
First Name & Middle Initial & Last Name & Degree
Darryl Adamko, MD
First Name & Middle Initial & Last Name & Degree
Bonita Lee, MD
First Name & Middle Initial & Last Name & Degree
Carina Majaesic, MD

12. IPD Sharing Statement

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

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