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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01008761
• Other study ID #: ALAWhZy2010
• Status: Recruiting
• Phase: N/A
• First received: November 4, 2009
• Last updated: July 11, 2012
• Start date: January 2010
• Est. completion date: December 2013

Study information

• Verified date: July 2012
• Source: Alberta Children's Hospital
• Contact: Janielee Williamson, RN
• Phone: 403-955-3186
• Email: janie.williamson[@]albertahealthservices.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 440
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months to 60 Months

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	Stollery Children's Hospital	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
Janielee Williamson	University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		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	Yes
Secondary	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		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	No
Secondary	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.		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	No