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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

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

NCT ID

NCT01008761

First Posted

November 4, 2009

Last Updated

July 11, 2012

Sponsor

Janielee Williamson

Collaborators

University of Alberta

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

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

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

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

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

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

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

janie.williamson@albertahealthservices.ca

First Name & Middle Initial & Last Name or Official Title & Degree

David W. Johnson, MD

Phone

403-955-7507

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

janie.williamson@albertahealthservices.ca

First Name & Middle Initial & Last Name & Degree

Paula Finnson

Phone

403-955-7873

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

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

Learn more about this trial

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

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