Trial · NCT03186209
Outcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Annual Asthma Exacerbation Rate in Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma for Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Full analysis set, Baseline eosinophils \>=300/uL | events/patient-year | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Week 48 in Pre-bronchodilator FEV1 (L) Value for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Full analysis set, Baseline eosinophils \>=300/uL; number analyzed refers to records with value available at Week 48 for this outcome measure | Liter | MEAN |
| SECONDARY | Change From Baseline at Week 48 in Total Asthma Symptom Score for for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Full analysis set, Baseline eosinophils \>=300/uL; number analyzed refers to records with value available at Week 48 for this outcome measure | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline at Week 48 in Total Asthma Rescue Medication Use for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Full analysis set, Baseline eosinophils \>=300/uL; number analyzed refers to records with value available at Week 48 for this outcome measure | Puffs/day | MEAN |
| SECONDARY | Change From Baseline at Week 48 in Morning Peak Expiratory Flow (PEF) for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Full analysis set, Baseline eosinophils \>=300/uL; number analyzed refers to records with value available at Week 48 for this outcome measure | L/min | MEAN |
| SECONDARY | Change From Baseline at Week 48 in Evening Peak Expiratory Flow (PEF) for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Full analysis set, Baseline eosinophils \>=300/uL; number analyzed refers to records with value available at Week 48 for this outcome measure | L/min | MEAN |
| SECONDARY | Change From Baseline at Week 48 in the Proportion of Night Awakening Due to Asthma and Requiring Rescue Medication for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Full analysis set, Baseline eosinophils \>=300/uL; number analyzed refers to records with value available at Week 48 for this outcome measure | Proportion of nights | MEAN |
| SECONDARY | Change From Baseline at Week 48 in Asthma Control Questionnaire 6 (ACQ-6) for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Full analysis set, Baseline eosinophils \>=300/uL; number analyzed refers to records with value available at Week 48 for this outcome measure | Scores on a scale | MEAN |
| SECONDARY | Time to First Asthma Exacerbation for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Full analysis set, Baseline eosinophils \>=300/uL | Days | MEDIAN |
| SECONDARY | Number and Percentage of Patients With >=1 Asthma Exacerbations Among Patients Who Were on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Full analysis set, Baseline eosinophils \>=300/uL | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline at Week 48 in Total Score of St. George's Respiratory Questionnaire (SGRQ) for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Full analysis set, Baseline eosinophils \>=300/uL; number analyzed refers to records with value available at Week 48 for this outcome measure | Scores on a scale | MEAN |
| SECONDARY | Annual Asthma Exacerbation Rate Associated With an Emergency Room/Urgent Care Visit or a Hospitalization for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Full analysis set, Baseline eosinophils \>=300/uL | events/patient-year | LEAST_SQUARES_MEAN |
| SECONDARY | Number and Percentages of Asthma Specific Health Care Resource Utilization for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Full analysis set, Baseline eosinophils \>=300/uL | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Pharmacokinetics (PK) of Benralizumab as Assessed by Trough Concentration | week 0, week 24, week 48 | PK analysis set; number analyzed includes participants with available value at each specified time point. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | The Immunogenicity of Benralizumab as Assessed by the Presence of Anti-drug Antibodies (ADAs) | Pre-treatment until end of 48-week end of treatment | Safety analysis set; number analyzed includes participants with available value at each specified time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change From Baseline at Week 48 in Blood Eosinophil Levels for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL | From randomization through Study Week 48 | Full analysis set, Baseline eosinophils \>=300/uL; number analyzed refers to records with value available at Week 48 for this outcome measure | Percent change | MEAN |
| OTHER_PRE_SPECIFIED | Annual Asthma Exacerbation Rate in Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils <300/uL | From randomization through Study Week 48. | Full analysis set, Baseline eosinophils \<300/uL | events/patient-year | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline at Week 48 in Pre-bronchodilator FEV1 (L) Value for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils <300/uL | From randomization through Study Week 48 | Full analysis set, Baseline eosinophils \<300/uL; number analyzed refers to records with value available at Week 48 for this outcome measure | Liter | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline at Week 48 in Total Asthma Symptom Score for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils <300/uL | From randomization through Study Week 48 | Full analysis set, Baseline eosinophils \<300/uL; number analyzed refers to records with value available at Week 48 for this outcome measure | Scores on a scale | MEAN |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03186209/outcomes