Trial · NCT01238861
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants | Week 1 up to Week 52 | The modified intent-to-treat (mITT) population included all randomized participants who received any dose of investigational product. | AER events/person-year | NUMBER |
| SECONDARY | Dose Response in EOS+ Participants | Baseline up to Week 66 | Due to change in planned analysis after unblinding of study data, dose response was not performed. | ||
| SECONDARY | Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ss) | Pre-dose (0 hour), Post-dose on Day 1, 6, Week 4, 16, 24, 32, 40, and 52 | The Pharmacokinetic (PK) Population included all participants who received at least one dose of benralizumab and had at least one quantifiable PK observation. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for PK in the 100 mg benralizumab group. | microgram per milliliter | MEAN |
| SECONDARY | Dose-Normalized Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ssD) | Pre-dose (0 hour), Post-dose on Day 1, 6, Week 4, 16, 24, 32, 40, and 52 | The PK Population included all participants who received at least one dose of benralizumab and had at least one quantifiable PK observation. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for PK in the 100 mg benralizumab group. | microgram per milliliter | MEAN |
| SECONDARY | Percentage of Participants With Anti-Drug Antibodies (ADA) to Benralizumab in Eosinophilic Phenotype (EOS+) Participants | Baseline up to Week 92 | The mITT population included all randomized participants who received any dose of investigational product. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 52 | Baseline up to Week 52 | The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Mean Total Nasal Symptoms Score (TNSS) at Week 52 | Baseline up to Week 52 | The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Mean Asthma Symptom Diary Score at Week 51-52 | Baseline up to Week 51-52 | The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Rescue Medication Use at Week 51-52 | Baseline up to Week 51-52 | The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. Data was summarized together for EOS+ and EOS- Placebo arms and EOS+ and EOS- benralizumab 100 mg arms. | rescue medication per 2 weeks | MEAN |
| SECONDARY | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 52 | Baseline and Week 52 | The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. | liters | MEAN |
| SECONDARY | Change From Baseline in Mean Forced Vital Capacity (FVC) at Week 52 | Baseline and Week 52 | The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. | liters | MEAN |
| SECONDARY | Change From Baseline in Peak Expiratory Flow (PEF) at Week 52 | Baseline and Week 52 | The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. | liters per minute | MEAN |
| SECONDARY | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Score at Week 52 | Baseline and Week 52 | The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. Data was summarized together for EOS+ and EOS- Placebo arms and EOS+ and EOS- benralizumab 100 mg arms. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in European Quality of Life - 5 Dimensions (EQ-5D) Health State Evaluation at Week 52 | Baseline and Week 52 | The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in EQ-5D Visual Analog Scale (VAS) at Week 52 | Baseline and Week 52 | The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Percentage of Nocturnal Awakening-Free Nights at Week 51-52 | Baseline up to Week 51-52 | The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. | percent nocturnal awakening-free nights | MEAN |
| SECONDARY | Change From Baseline in Mean Fraction Exhaled Nitric Oxide (FeNO) at Week 52 | Baseline up to Week 52 | The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. | parts per billion | 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
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GET https://conductscience.org/api/trials/v1/NCT01238861/outcomes