Trial · NCT02322775
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (L) at Week 12 | Baseline, Week 4, Week 8 and Week 12 | The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study. | Litre | MEAN |
| SECONDARY | Change From Baseline in Morning Peak Expiratory Flow (PEF) (L/Min) at Home at Week 12 | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12 | The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study. | L/min | MEAN |
| SECONDARY | Change From Baseline in Evening Peak Expiratory Flow (PEF) (L/Min) at Home at Week 12 | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12 | The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study. | L/min | MEAN |
| SECONDARY | Change From Baseline in Total Asthma Symptom Score at Week 12 | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12 | The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study. | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Total Asthma Rescue Medication Use (Puffs) at Week 12 | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12 | The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study. | Puffs per day | MEAN |
| SECONDARY | Change From Baseline in Proportion of Nights With Nocturnal Awakenings at Week 12 | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12 | The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study. | Proportion of nights | MEAN |
| SECONDARY | Change From Baseline in Mean ACQ-6 Score at Week 12 | Baseline, Week 4, Week 8 and Week 12 | The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study. | Scores on a scale | MEAN |
| SECONDARY | Asthma Exacerbations | Up to Week 12 | The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study. | Patients per number of exacerbations | NUMBER |
| SECONDARY | Change From Baseline in AQLQ(S)+12 Total and Domain Scores at Week 12 | Baseline and Week 12 | The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study. | Scores on a scale | MEAN |
| SECONDARY | Serum Concentrations (ng/mL) | Baseline, Week 12 and Week 20 | The pharmacokinetic (PK) analysis set comprised all patients who received benralizumab and from whom PK blood samples were obtained are assumed not to be affected by factors such as protocol violations. Those patients who had at least 1 quantifiable serum PK observation post first dose were included in the PK analysis dataset. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Peripheral Blood Eosinophil Levels | Baseline, Week 12 and Week 20 | The safety analysis set comprised all patients who received at least one dose of IP. Patients were classified according to the treatment they actually received. A patient who has on one or several occasions received active treatment was classified as active. | Cells/µL | MEDIAN |
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/NCT02322775/outcomes