Trial for the Treatment of Acute Asthma in Wheezy Pre-sch... | NCT01008761 | Trialant

Trial for the Treatment of Acute Asthma in Wheezy Pre-sch... | NCT01008761 | Trialant

Sponsor/Collaborators Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Zithromax, 100 mgmgs; 5mls suspension	Active Comparator	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
Suspension placebo,	Placebo Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Azithromycin	Drug	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)

Outcomes Module

Primary Outcomes

Measure	Description	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		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 Outcomes

Measure	Description	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		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.

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Janielee Williamson, RN	Contact	403-955-3186		janie.williamson@albertahealthservices.ca
David W. Johnson, MD	Contact	403-955-7507		david.johnson@alberthealthservices.ca

Overall Officials

Name	Affiliation	Role
David W Johnson, MD	Alberta children's Hospital/University of Calgary	Principal Investigator
Piush Mandhane, MD	Stollery Children's Hospital Edmonton	Principal Investigator

Condition Browse Module

Intervention Browse Module