A Study to Evaluate the Onset of Effect and Time Course of Change in Lung Function With Benralizumab in Severe, Uncontrolled Asthma Patients With Eosinophilic Inflammation
- Registration Number
- NCT02869438
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to investigate the onset and maintenance of effect of benralizumab on lung function, blood eosinophils, asthma control metrics and quality of life during 12-week treatment in patients with uncontrolled, severe asthma with eosinophilic inflammation. A subset of patients will take part in body plethysmography substudy to further investigate the effect on lung function.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 233
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo arm Placebo Placebo administered subcutaneously Benralizumab arm Benralizumab Benralizumab administered subcutaneously
- Primary Outcome Measures
Name Time Method 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.
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 Outcome Measures
Name Time Method 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.
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.
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.
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.
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.
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.
Duration of IP Administration From first IP to last IP Duration of IP administration is last IP dose date - first IP dose +1.
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
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
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. \[Note: Day 28, 56, 84 are presented in the Primary measure.\]
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.
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.
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.
Trial Locations
- Locations (1)
Research Site
🇵🇭Quezon City, Philippines