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 placeboTreatment 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
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