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Trial · NCT00675584

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryRate of Exacerbations Requiring Systemic CorticosteroidsMeasured during the 12-month follow-up periodThe rate of exacerbations was calculated as the number of exacerbations requiring prednisone per years of follow-up
SecondaryProportion of Episode-free DaysMeasured during the 12-month follow-up periodAn episode-free day consisted of no asthma symptoms and no asthma rescue medications
SecondaryNumber of Urgent Care Visits, Emergency Department Visits, or Hospitalizations for Wheezing or Asthma Per 12 MonthsMeasured during the 12-month follow-up period
SecondaryNumber of Participants With Treatment FailureMeasured during the 12-month follow-up period
Treatment failure was defined as the occurrence of at least one of the following events: 1. four courses of systemic corticosteroids 2. one hospitalization for acute exacerbation of wheezing 3. hypoxic seizure during an acute exacerbation of asthma/wheezing 4. intubation for acute asthma/wheezing 5. serious adverse event related to a study medication 6. physician discretion with specific rationale
SecondaryChange Between 12 Months and Baseline in Exhaled Nitric Oxide (eNO)baseline and 12 monthsExhaled nitric oxide (eNO) is measured in parts per billion, and the change constructed between 12 months and baseline
SecondaryChange Between 12 Months and Baseline in Pulmonary Reactance and Resistance Measured Via Oscillometrybaseline and 12 months
SecondaryAdverse Events Associated With Corticosteroid UseMeasured during the 12-month follow-up period
SecondaryNumber of Days of Absence From Daycare and Preschool for the Child and From Work for the Caregiver Per 12 MonthsMeasured during the 12-month follow-up period
SecondaryProportion of Days With Rescue Albuterol UseMeasured during the 12-month follow-up period
SecondaryChange in Wheeze Severity During a Respiratory Tract IllnessMeasured during the first seven days for each respiratory tract illnessWheeze severity is scored as 0 (none) to 5 (very severe) during a respiratory tract illness
SecondaryChange Between 12 Months and Baseline in the Caregiver Quality-of-lifebaseline and 12 monthsThe caregiver quality-of-life questionnaire consists of seven questions, each scored from 0 (worse) to 3 (best), and all seven questions are summed to yield a total score ranging from 0 to 21

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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