Trial · NCT02155660
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 COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL | Immediately following the first IP dose through week 56 | Full analysis set, baseline EOS\>=220/uL | Exacerbations per year | LEAST_SQUARES_MEAN |
| SECONDARY | Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS<220/uL | Immediately following the first IP dose through week 56 | Full analysis set, baseline EOS\<220/uL | Exacerbations per year | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline EOS>=220/uL | First IP up to end of treatment Week 56 | Full analysis set, baseline EOS\>=220/uL | Liter | MEAN |
| SECONDARY | Mean Change From Baseline in SGRQ Total Score for Patients With Baseline EOS>=220/uL | First IP up to Week 56 | Full analysis set, baseline EOS\>=220/uL | Percentage | MEAN |
| SECONDARY | Mean Change From Baseline in CAT Total Score for Patients With Baseline EOS>=220/uL | First IP up to Week 56 | Full analysis set, baseline EOS\>=220/uL | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in E-RS: COPD Total Score for Patients With Baseline EOS>=220/uL | First IP up to Week 56 | Full analysis set, baseline EOS\>=220/uL | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Total Rescue Medication Use (Number of Puffs Per Day) for Patients With Baseline EOS>=220/uL | First IP up to Week 56 | Full analysis set, baseline EOS\>=220/uL | Puffs/day | MEAN |
| SECONDARY | Mean Change From Baseline in Proportion of Nights With Awakenings Due to Respiratory Symptoms for Patients With Baseline EOS>=220/uL | First IP up to Week 56 | Full analysis set, baseline EOS\>=220/uL | Proportion of nights | MEAN |
| SECONDARY | Number of Participants by Number of COPD Exacerbations Based on EXACT-PRO for Patients With Baseline EOS>=220/uL | Immediately following first IP up to week 56 | Full analysis set, EOS\>=220/uL | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Severity of EXACT-PRO for Patients With Baseline EOS>=220/uL | Immediately following first IP up to week 56 | Full analysis set, baseline EOS\>=220/uL | Score on a scale | MEAN |
| SECONDARY | Duration of COPD Exacerbation Based on EXACT-PRO Score for Patients With Baseline EOS>=220/uL | Immediately following first IP up to week 56 | Full analysis set, baseline EOS\>=220/uL | Days | MEAN |
| SECONDARY | Annual EXACT-PRO Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL | Immediately following the first IP dose through week 56 | Full analysis set, baseline EOS\>=220/uL | Exacerbations per year | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Having at Least 1 COPD Exacerbation for Patients With Baseline EOS>=220/uL | Immediately following first IP dose up to week 56 | Full analysis set, baseline EOS\>=220/uL | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to First COPD Exacerbation | Immediately following IP dose to Week 56 | Full analysis set, baseline EOS\>=220/uL | Days | MEDIAN |
| SECONDARY | Annual COPD Exacerbation Rate Associated With ER or Hospitalization Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL | Immediately following the first IP dose through week 56 | Full analysis set, baseline EOS\>=220/uL | Exacerbations per year | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Had COPD-related Healthcare Encounter for Patient With Baseline EOS>=220/uL | Immediately following first IP dose up to Week 56 | Full analysis set, baseline EOS\>=220/uL | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Study Treatment Administration | From first dose date to last dose date, 48 weeks per protocol. | Safety analysis set | Days | MEAN |
| SECONDARY | Serum Concentration of Benralizumab | Pre-first dose and pre-dose at end of treatment (week 56). | PK analysis set | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Immunogenicity of Benralizumab | Pre-treatment until end of follow-up, week 60 per protocol. | Safety analysis set. For each parameter, the number of subjects at risk is to be analyzed. | Participants | COUNT_OF_PARTICIPANTS |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02155660/outcomes