WithdrawnPhase 4

Pulmicort Respules on Relapse Rates After Treatment in the ED

Stopped: study halted prematurely before enrollment of first patient

United States0Started 2007-10

Plain-language summary

The purpose of this study is to see if the addition of budesonide to oral corticosteroids will result in a decrease in relapse rates compared to oral corticosteroids alone in children who are discharged from the ED after an asthma exacerbation. Secondly, that there will be an improvement in lung function, a decrease in beta-2 agonist use and an improvement in health-related quality of life compared to placebo.

Who can participate

Age range2 Years – 8 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Patient is between the ages of 2 and 8 * Has previously been diagnosed with asthma by any physician * Has presented to the ED with an asthma exacerbation judged by a physician that is believed would not required admission to the hospital Exclusion Criteria: * Children less than 2 years (wheezing may be due to bronchiolitis) * Children who have been on oral or inhaled corticosteroid in the last week, are pregnant, or unavailable for follow-up * Pregnant * Has chronic lung diseases (i.e. cystic fibrosis)

What they're measuring

Number of unplanned ED or PCP visits for asthma in the 1 month following an ED visit for an asthma exacerbation.

Timeframe: 28 days

Trial details

NCT IDNCT00584636

SponsorPhoenix Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-03

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