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

Information source: Alberta Children's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Azithromycin (Drug); Suspension Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Janielee Williamson

Official(s) and/or principal investigator(s):
David W Johnson, MD, Principal Investigator, Affiliation: Alberta children's Hospital/University of Calgary
Piush Mandhane, MD, Principal Investigator, Affiliation: Stollery Children's Hospital Edmonton

Overall contact:
Janielee Williamson, RN, Phone: 403-955-3186, Email: janie.williamson@albertahealthservices.ca

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 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:

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.

Eligibility

Minimum age: 12 Months. Maximum age: 60 Months. Gender(s): Both.

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

Locations and Contacts

Janielee Williamson, RN, Phone: 403-955-3186, Email: janie.williamson@albertahealthservices.ca

Alberta Children's Hospital, Calgary, Alberta T3B 6A8, Canada; Recruiting
Janielee Williamson, RN, Phone: 403-955-3186, Email: janie.williamson@albertahealthservices.ca
Paula Finnson, Phone: 403-955-7873, Email: paula.finnson@albertahealthservices.ca
David Johnson, MD, Principal 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, Sub-Investigator

Stollery Children's Hospital, Edmonton, Alberta T6G 2V7, Canada; Recruiting
Piush Mandhane, MD, Email: piush.mandhane@albertahealthservices.ca
Piush Mandhane, MD, Principal Investigator
William Craig, MD, Sub-Investigator
Darryl Adamko, MD, Sub-Investigator
Bonita Lee, MD, Sub-Investigator
Carina Majaesic, MD, Sub-Investigator

Additional Information

Starting date: January 2010
Last updated: July 11, 2012

Page last updated: August 23, 2015

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