Budesonide Inhalation Suspension for Acute Asthma in Children

PHASE4CompletedINTERVENTIONAL
Enrollment

179

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

November 30, 2007

Study Completion Date

November 30, 2007

Conditions
AsthmaAcute AsthmaReactive Airway Exacerbation
Interventions
DRUG

Budesonide inhalation suspension (0.5 mg/2mL) 2mg, albuterol (5mg/mL) 7.5 or 10mg

Patients randomized to budesonide inhalation suspension (BIS) receive 2 nebulized albuterol sulfate (5mg/mL) doses (2mL =10mg for patients over 20kg, 1.5mL =7.5mg for patients 10-20kg) mixed with 8mL (2mg) of BIS(0.5mg/2mL). The albuterol sulfate and BIS mixture is delivered by a medium volume, high flow nebulizer (AirLife Mister FinityTM)with an oxygen flow rate of 8L/min via a tight-fitting face mask.

DRUG

Prednisolone, prednisone, or methylprednisolone

All patients are given 2mg/kg of systemic corticosteroids (max 60mg). Patients who can tolerate pills are given oral prednisone, those who cannot are given oral prednisolone, and those who cannot tolerate oral medications are given IV methylprednisolone.

DRUG

Albuterol, ipratropium bromide

While guardians are approached for possible participation, patients are given a single nebulized dose of albuterol sulfate (5mg/mL) mixed with ipratropium bromide (500mcg/2.5mL). Patients who weigh 10-20kg receive 3.75mg of albuterol. Patients over 20kg receive 5mg of albuterol. All patients receive 500mcg of ipratropium bromide. Albuterol sulfate and ipratropium bromide are delivered by a medium volume, high flow nebulizer (AirLife Mister FinityTM)with an oxygen flow rate of 8L/min via a tight-fitting face mask.

DRUG

Ipratropium bromide

500 mcg/2.5mL. All patients receive a final dose of ipratropium bromide after the intervention or placebo. The ipratropium bromide is delivered by a medium volume, high flow nebulizer (AirLife Mister FinityTM) with an oxygen flow rate of 8L/minute via a tight-fitting face mask.

Trial Locations (1)

19104

Children's Hospital of Philadelphia Emergency Department, Philadelphia

All Listed Sponsors
lead

Children's Hospital of Philadelphia

OTHER

NCT00393367 - Budesonide Inhalation Suspension for Acute Asthma in Children | Biotech Hunter | Biotech Hunter