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Trial · NCT02075255

Outcomes34

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPercentage Reduction in Final OCS Dose Compared With Baseline While Maintaining Asthma ControlWeek 28Full analysis setPercentMEDIAN
SECONDARYNumber and Percentage of Patients in Different Categories of Percent Reduction From Baseline in Final OCS Dose While Maintaining Asthma ControlWeek 28Full analysis setParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPercentage Reduction in Final OCS Dose Compared With Baseline While Maintaining Asthma Control for Patients With Baseline Eosinophils >=300/uLWeek 28Full analysis set, baseline blood eosinophil \>=300/uLPercentMEDIAN
SECONDARYThe Percentage of Patients With ≥50% Reduction in Average Daily OCS Dose at Visit 14 Compared With Baseline Dose at Visit 6, While Maintaining Asthma ControlWeek 28Full analysis setParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYThe Proportion of Eligible Patients With ≥100% Reduction in Average Daily OCS Dose at Visit 14 Compared With Baseline Dose at Visit 6, While Maintaining Asthma ControlWeek 28Full analysis set, eligible for 100% reduction (ie, patients with baseline OCS dose \<= 12.5 mg)ParticipantsNUMBER
SECONDARYThe Proportion of Patients With ≤5.0 mg Reduction on Daily OCS Dose at Visit 14 Compared With Baseline Dose at Visit 6, While Maintaining Asthma Control.Week 28Full analysis setParticipantsNUMBER
SECONDARYThe Proportion of Patients With Average Final OCS Dose ≤5.0 mg Daily at Visit 14, While Maintaining Asthma ControlWeek 28Full analysis setParticipantsNUMBER
SECONDARYNumber and Percentage of Patients With ≥1 Asthma ExacerbationImmediately following the randomisation through Study Week 28Full analysis setParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYTime to the First Asthma ExacerbationThe time from randomisation to the date of first asthma exacerbation over 28 weeksFull analysis setDaysMEDIAN
SECONDARYTime to the First Asthma Exacerbation Requiring Hospitalization or ER VisitThe time from randomisation to the date of first asthma exacerbation associated with hospitalization or ER over 28 weeks.Full analysis setDaysMEDIAN
SECONDARYThe Annualized Rate of Asthma ExacerbationThe time from randomisation to the date of week 28 visit (end of treatment) or last contact if the patient is lost to follow upFull analysis setevents/yearLEAST_SQUARES_MEAN
SECONDARYThe Annualized Rate of Asthma Exacerbations That Are Associated With an Emergency Room Visit or a HospitalizationThe time from randomisation to the date of week 28 visit (end of treatment) or last contact if the patient is lost to follow upFull analysis setevents/yearLEAST_SQUARES_MEAN
SECONDARYNumber of Days in Hospital Due to AsthmaThe time from randomisation to the date of week 28 visit (end of treatment) or last contact if the patient is lost to follow upFull analysis setDaysMEAN
SECONDARYChange From Baseline to Week 28 in Pre-bronchodilator FEV1Change from baseline at week 28Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.LiterMEAN
SECONDARYChange From Baseline to Week 28 in Asthma Symptom Scores (Total)Change from baseline at week 28Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.Scores on a scaleMEAN
SECONDARYChange From Baseline to Week 28 in Asthma Symptom Scores (Daytime)Change from baseline at week 28Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.Scores on a scaleMEAN
SECONDARYChange From Baseline to Week 28 in Asthma Symptom Scores (Nighttime)Change from baseline at week 28Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.Scores on a scaleMEAN
SECONDARYChange From Baseline to Week 28 in Rescue Medication UseChange from baseline at week 28Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.number of puffs per dayMEAN
SECONDARYChange From Baseline to Week 28 in Home Lung Function (Morning Peak Expiratory Flow)Change from baseline at week 28Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.Liter/minMEAN
SECONDARYChange From Baseline to Week 28 in Home Lung Function (Evening Peak Expiratory Flow)Change from baseline at week 28Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.Liter/minMEAN

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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