RCT 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”

To determine if treatment of pre-school children with a history of wheeze who present to an ED with an acute wheezing episode with azithromycin for 5 days will resolve their symptoms more quickly, will require less SABA, and allow these children to remain symptom free for a longer period of time.

Intervention(s) in this Clinical Trial

• 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)
• Drug: Placebo
  • Placebo suspension will be administered on day 1 at 10mg/kg and then for the next 4 days at 5 mg/kg

Arms, Groups and Cohorts in this Clinical Trial

• 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)
• Placebo Comparator: Placebo suspension produced by Pfizer Pharmaceutical Corp.
  • Placebo suspension provided by Company to be administered in the same way as the treatment arm. Amount for day 1 then reduced amount for 4 additional days - given in a syringe squirted into the child's mouth

Primary Measures

• To determine if treatment of pre-school children with a history of wheeze who present to an ED with an acute wheezing episode with Azithromycin for 5 days will resolve their symptoms more quickly
  • Time Frame: Duration of study
    Safety Issue?: Yes

Secondary Measures

• To determine if treatment of pre-school children, who experience an acute wheezing episode, with Azithromycin for 5 days will require less SABA, and allow these children to remain symptom free for a longer period of time.
  • Time Frame: Study duration
    Safety Issue?: No

Inclusion Criteria:

• 12-60 months
• wheeze on auscultation
• plan is to discharge

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Months

Maximum Age for this Clinical Trial: 60 Months

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Alberta Children's Hospital Other

Overall Clinical Trial Officials and Contacts

David W Johnson, MD Principal Investigator Alberta children's Hospital/University of Calgary  

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

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01008761

Study ID Number: ALAWhZy2010

ClinicalTrials.gov Identifier: NCT01008761

Health Authority: Canada: Health Canada