Trial · NCT02869438
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline (Visit 4) to Day 28 (Visit 8), Day 56 (Visit 9), and Day 84 (Visit 10) in Pre-BD FEV1 | From first IP dose to Day 84 | The average over the mean differences between benralizumab and placebo for change from baseline in pre-BD FEV1 is used to determine if the study is positive and to determine maintenance of effect. The first post baseline time point where the p-value for the mean difference between benralizumab and placebo is less than or equal to 0.05 is used to determine time to onset of effect. |
| Primary | Change From Baseline (Visit 4) to End of Treatment Day 84 (Visit 10) in Residual Volume (RV) | From first IP dose to Day 84 | Body plethysmography was performed for sub-study patients. Lung volume subdivisions measures were performed by the investigator or qualified designee according to ATS/ERS guidelines. |
| Secondary | Percent Change From Baseline to End of Treatment in Eosinophils Counts | From first IP dose to Day 84 | Percent change from baseline to Day 84 |
| Secondary | Change From Baseline (Visit 4) to Post Baseline Visits in Pre-BD FEV1 | From first IP dose to Day 84 | Post baseline visits include Day 3, Day 7, Day 14, Day 28, Day 56, Day 84. \[Note: Day 28, 56, 84 are presented in the Primary measure.\] |
| Secondary | Change From Baseline to Post Baseline for Pre-BD FVC | From first IP dose to Day 84 | Post baseline visits include Day 3, Day 7, Day 14, Day 28, Day 56, and Day 84. |
| Secondary | Percentage of Pre-BD FEV1 Responder | From first IP dose to Day 84 | Pre-BD FEV1 responder is defined as change from baseline in FEV1 \>=100 ml |
| Secondary | Change From Baseline in ACQ-6 | From first IP dose to Day 84 | ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of \<=0.75 indicates well-controlled asthma, scores between 0.75 to \<=1.5 indicate partly controlled asthma, and \>1.5 indicates not well controlled asthma. |
| Secondary | Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) | From first IP dose to Day 84 | The SGRQ is designed to measure health impairment in patients with asthma and COPD. It contains two parts: Part 1 (Questions 1 to 8) covers the patients' recollection of their symptoms over a preceding 4 weeks; Part 2, 42 items, relates to the daily activity and psychosocial impacts of the individual's respiratory condition. Total score is presented as a percentage of overall impairment, in which 100 represents the worst possible health status, while 0 indicates the best. |
| Secondary | Change From Baseline to End of Treatment in FeNO | From first IP dose to Day 84 | Airway inflammation was evaluated via fractional exhaled nitric oxide (FeNO) measurement. |
| Secondary | Change From Baseline to End of Treatment in Total Lung Capacity (TLC) for Sub-study Patients | From first IP dose to Day 84 | Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements. |
| Secondary | Change From Baseline to End of Treatment in Ratio of Residual Volume (RV) and Total Lung Capacity (TLC) for Sub-study Patients | From first IP dose to Day 84 | Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements. |
| Secondary | Change From Baseline to End of Treatment in Inspiratory Capacity (IC) for Sub-study Patients | From first IP dose to Day 84 | Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements. |
| Secondary | Change From Baseline to End of Treatment in Functional Residual Capacity (FRC) for Sub-study Patients | From first IP dose to Day 84 | Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements. |
| Secondary | Change From Baseline to End of Treatment in Vital Capacity (VC) for Sub-study Patients | From first IP dose to Day 84 | Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements. |
| Secondary | Duration of IP Administration | From first IP to last IP | Duration of IP administration is last IP dose date - first IP dose +1. |
| Other | Serum Concentration of Benralizumab | From first dose to end of treatment period (Day 84) | PK sample was collected pre-dose at each visit |
| Other | PK Parameter of Benralizumab (Cmax) | First IP dose cycle (ie, data collected on Days 3, 7, 14 and 28) | PK parameters are derived in patients with at least three qualifiable serum PK concentrations post first dose (collected on Day 3, 7, and either 14, or 28) |
| Other | Anti-drug Antibody Responses | From first IP dose to end of treatment period (Day 84) | Anti-drug antibody responses at baseline and post baseline, including nAb responses |
| Other | Change From Baseline to End of Treatment in PGI-S | From first IP dose to Day 84 | The patient global impression of severity (PGI-S) is a single item designed to capture the patient's perception of overall symptom severity at the time of the completion using a 6-point categorical response scale (no symptom \[0\] to very severe symptom \[5\]) |
| Other | Change From Baseline to End of Treatment in CGI-C | From first IP dose to Day 84 | Clinician global impression of change (CGI-C) is used for an overall evaluation of response to treatment. The investigator is asked to rate the degree of change in overall asthma status compare to the start of treatment. A 7-point rating scale is used from 1=very much improved to 7=very much worse. |
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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