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Trial · NCT01430403

Outcomes22

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYOccurrence of One or More Asthma Exacerbations (All Treatment Steps [Steps 2-5])90 Day outcome periodIntent-to-treatPercent of adjusted prevalenceNUMBER
PRIMARYOccurrence of One or More Asthma Exacerbations (Treatment Steps 2-4)90 Day outcome periodIntent-to-treatPercent of adjusted prevalenceNUMBER
SECONDARYVirus-induced Exacerbations as Measured by an Exacerbation That is Associated With a Virus Detected Using the Nasal Mucus Samples90 Day outcome periodNasal mucus samplesPercent Samples with virusNUMBER
SECONDARYSeverity of Asthma Symptoms Associated With a Viral Infection:Omalizumab vs. Placebo90 Day outcome periodThe pre-specified intent for Outcome Measure: analysis inclusion limited to the Omalizumab and Placebo Groups.~Analysis: intent-to-treat (with available data).Maximum Symptoms DaysMEAN
SECONDARYNumber of Exacerbations Evaluated Monthly With Viral Respiratory Infections: Omalizumab vs. Placebo90 Day outcome periodThe pre-specified intent for Outcome Measure: analysis inclusion limited to the Omalizumab and Placebo Groups.~Analysis: intent-to-treat (with available data).Total Number of Viral InfectionsMEAN
SECONDARYComposite Asthma Severity Index (CASI), Treatment Steps 2-5: Omalizumab vs. Placebo90 Day outcome periodIntent-to-treatCASI ScoreMEAN
SECONDARYComposite Asthma Severity Index (CASI), Treatment Steps 2-4: Omalizumab vs. ICS90 Day outcome periodIntent-to-treat with available CASI scoresCASI ScoreMEAN
SECONDARYSpirometry Measurements: Forced Expiratory Volume in 1 Second (FEV1) % Predicted, Treatment Steps 2-5:Omalizumab vs. Placebo90 Day outcome periodIntent-to-treatpercent predicted FEV1MEAN
SECONDARYSpirometry Measurements: Forced Expiratory Volume in 1 Second (FEV1) % Predicted , Treatment Steps 2-4: Omalizumab vs. ICS90 Day outcome periodIntent-to-treatpercent predicted FEV1MEAN
SECONDARYSpirometry Measurements: FEV1:FVCx100, Treatment Steps 2-5: Omalizumab vs. Placebo90 Day outcome periodIntent-to-treatpercent FEV1/FVC ratioMEAN
SECONDARYSpirometry Measurements: FEV1:FVCx100, Treatment Steps 2-4: Omalizumab vs. ICS90 Day outcome periodIntent-to-treatpercent FEV1/FVC ratioMEAN
SECONDARYAsthma Control Test Scores: Asthma Control Test (ACT), Treatment Steps 2-5: Omalizumab vs. Placebo90 Day outcome periodIntent-to-treat with available ACT scoresACT ScoreMEAN
SECONDARYAsthma Control Test Scores: Asthma Control Test (ACT), Treatment Steps 2-4: Omalizumab vs. ICS90 Day outcome periodIntent-to-treat with available ACT ScoresACT ScoreMEAN
SECONDARYAsthma Control Test Score: Child Asthma Control Test (C-ACT), Treatment Steps 2-5: Omalizumab vs. Placebo90 Day outcome periodIntent-to-treat with available C-ACT ScoresC-ACT ScoreMEAN
SECONDARYAsthma Control Test Score: Child Asthma Control Test (C-ACT), Treatment Steps 2-4: Omalizumab vs. ICS90 Day outcome periodIntent-to-treat with available C-ACT ScoresC-ACT ScoreMEAN
SECONDARYWork Disruptions Due to Child's Asthma, Treatment Steps 2-5: Omalizumab vs. Placebo90 Day outcome periodIntent-to-treat with available dataRatioMEAN
SECONDARYWork Disruptions Due to Child's Asthma, Treatment Steps 2-4: Omalizumab vs. ICS90 Day outcome periodIntent-to-treat with available dataRatioMEAN
SECONDARYSchool Absences (Percent), Treatment Steps 2-5:Omalizumab vs. Placebo90 Day outcome periodIntent-to-treatRatioMEAN
SECONDARYSchool Absences (Percent), Treatment Steps 2-4: Omalizumab vs. ICS90 Day outcome periodIntent-to-treatRatioMEAN
SECONDARYPercent Adherence to Asthma Medication, Treatment Steps 2-5: Omalizumab vs. Placebo90 Day outcome periodIntent-to-treatpercent adherenceMEAN

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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