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

July 11, 2012 updated by: Janielee Williamson

A Double Blind Randomized Control Trail of Azithromycin for the Acute Management of Wheezy Pre-school Children

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

440

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Recruiting
        • Alberta Children's Hospital
        • Principal Investigator:
          • David Johnson, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Sheldon Spier, MD
        • Sub-Investigator:
          • James D Kellner, MD
        • Sub-Investigator:
          • Candice Bjornson, MD
        • Sub-Investigator:
          • Michael Surrette, PhD
        • Sub-Investigator:
          • Alberto Nettle-Aguire, PhD
      • Edmonton, Alberta, Canada, T6G 2V7
        • Recruiting
        • Stollery Children's Hospital
        • Contact:
        • Principal Investigator:
          • Piush Mandhane, MD
        • Sub-Investigator:
          • William Craig, MD
        • Sub-Investigator:
          • Darryl Adamko, MD
        • Sub-Investigator:
          • Bonita Lee, MD
        • Sub-Investigator:
          • Carina Majaesic, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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)
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)
Other Names:
  • Azithromycin, zithromax, macrolide
Placebo Comparator: Suspension placebo,
placebo (suspension produced by CDC Edmonton.) given at 10 mg/kg/day for day 1, then 5 mg/kg for 4 days.
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
Other Names:
  • Azithromycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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 Measures

Outcome Measure
Time Frame
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janielee Williamson

Collaborators

University of Alberta

Investigators

  • Principal Investigator: David W Johnson, MD, Alberta Children's Hospital/University of Calgary
  • Principal Investigator: Piush Mandhane, MD, Stollery Children's Hospital Edmonton

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

November 4, 2009

First Submitted That Met QC Criteria

November 5, 2009

First Posted (Estimate)

November 6, 2009

Study Record Updates

Last Update Posted (Estimate)

July 12, 2012

Last Update Submitted That Met QC Criteria

July 11, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALAWhZy2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma

Clinical Trials on Azithromycin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe