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

Janielee Williamson

Status: Unknown

Conditions: Asthma

Treatments: Drug: Suspension Placebo; Drug: Azithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT01008761

ALAWhZy2010

Details and patient eligibility

About

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.

Enrollment: 440 estimated patients

Sex: All

Ages: 12 to 60 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

440 participants in 2 patient groups, including a placebo group

Zithromax, 100 mgmgs; 5mls suspension

Active Comparator group

Description:

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)

Treatment:

Drug: Azithromycin

Suspension placebo,

Placebo Comparator group

Description:

placebo (suspension produced by CDC Edmonton.) given at 10 mg/kg/day for day 1, then 5 mg/kg for 4 days.

Treatment:

Drug: Suspension Placebo