Trial · NCT01238861
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants | Week 1 up to Week 52 | The annual asthma exacerbation rate (AER) was calculated as the total number of observed exacerbations in each group up to week 52, divided by total duration of person-year follow-up in each group. An asthma exacerbation is defined as a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 days as prescribed or administered by the investigator or healthcare provider; or 2) participant initiation of systemic corticosteroids (tablets, suspension or injection) for a duration of at least 3 days as outlined in the Asthma Action Plan provided to the participant by the investigator on Day 1. |
| Secondary | Dose Response in EOS+ Participants | Baseline up to Week 66 | |
| 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 | |
| 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 | |
| Secondary | Percentage of Participants With Anti-Drug Antibodies (ADA) to Benralizumab in Eosinophilic Phenotype (EOS+) Participants | Baseline up to Week 92 | Immunogenicity assessment included determination of anti-drug (benralizumab) antibodies in serum samples. ADA positive was defined as a titer \>=50 at any point in the study. It was observed at baseline and any visit during the study. |
| Secondary | Change From Baseline in Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 52 | Baseline up to Week 52 | Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score was the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score. ACQ-6 score was summarized together for all participants. |
| Secondary | Change From Baseline in Mean Total Nasal Symptoms Score (TNSS) at Week 52 | Baseline up to Week 52 | Total Nasal Symptoms Score (TNSS) is a 3-item questionnaire, the sum of nasal symptoms, namely, nasal obstruction (rhinorrhea), nasal congestion, and nasal itching/sneezing. Each symptom was rated on a scale from 0-3, with 0 representing no symptoms, 1 mild, 2 moderate, and 3 severe symptoms. TNSS score was a summation of the 3 individual nasal symptom. TNSS score could range from 0 to 9 where higher score indicates worsening. Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms. |
| Secondary | Change From Baseline in Mean Asthma Symptom Diary Score at Week 51-52 | Baseline up to Week 51-52 | Asthma Symptom Diary included 7 questions about the participant symptom and the overall impact of treatment on the disease during the study period. Mean scores of the 7 questions were calculated to identify asthma symptom-free days. Asthma Symptom Diary Scores were analyzed on a bi-weekly basis and compared to baseline scores. Overall symptom score=(daytime frequency score + daytime severity score + nighttime severity score)/3, where total score ranges from 0 to 9. Higher score represents worsening. Mean asthma symptom diary score were summarized together for all participants. Mean asthma symptom diary score were summarized together for all participants. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms. |
| Secondary | Change From Baseline in Rescue Medication Use at Week 51-52 | Baseline up to Week 51-52 | Participants were provided inhalers of the same dose (medium- or high-dose) inhaled corticosteroid (ICS) plus long-acting beta antagonist (LABA) combination product as baseline prophylactic medication and continued with same dose throughout the study. Rescue medications such as short-term beta2 agonists were used as first-line treatment for worsening asthma symptoms. Investigator prescribed additional short term asthma controller medications included additional ICS, theophylline, inhaled cromones or antimuscarinics; if asthma symptoms remained mild but not resolved. If asthma symptoms worsened, participants received an oral corticosteroid burst. All rescue medications use with prophylactic medication (+ prophylactic) and without prophylactic medication (- prophylactic) was recorded in asthma symptom dairy by participant. Rescue medication use was analyzed on a bi-weekly basis and compared to baseline scores. |
| Secondary | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 52 | Baseline and Week 52 | FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms. |
| Secondary | Change From Baseline in Mean Forced Vital Capacity (FVC) at Week 52 | Baseline and Week 52 | Forced Vital Capacity (FVC) was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. |
| Secondary | Change From Baseline in Peak Expiratory Flow (PEF) at Week 52 | Baseline and Week 52 | The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed while sitting or standing prior to using any medication (if needed) for asthma. Home PEF was determined separately for morning and evening, and were averaged for each participant. Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms. |
| Secondary | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Score at Week 52 | Baseline and Week 52 | AQLQ: a 32-item questionnaire evaluating quality of life of participants with asthma including 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). The AQLQ(S) responses were categorized as improvement (defined as change from baseline \>=0.5), no change (defined as change from baseline \>= -0.5 to less than \[\<\] 0.5), and worse (defined as change from baseline \< -0.5). Data was summarized by each treatment group. |
| Secondary | Change From Baseline in European Quality of Life - 5 Dimensions (EQ-5D) Health State Evaluation at Week 52 | Baseline and Week 52 | The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The health state valuation was the summary score of mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a 3 category scale (no problem, moderate problem, severe problems). Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms. |
| Secondary | Change From Baseline in EQ-5D Visual Analog Scale (VAS) at Week 52 | Baseline and Week 52 | The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The EQ-5D VAS was measured from 0 (worst imaginable health state) to 100 (best imaginable health state). Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms. |
| Secondary | Change From Baseline in Percentage of Nocturnal Awakening-Free Nights at Week 51-52 | Baseline up to Week 51-52 | Percentage of nocturnal awakening-free nights were analyzed on a bi-weekly basis and compared to baseline scores. Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms. |
| Secondary | Change From Baseline in Mean Fraction Exhaled Nitric Oxide (FeNO) at Week 52 | Baseline up to Week 52 | Data was summarized by each treatment group. In addition, data was summarized together for "EOS+ and EOS- Placebo" arms and "EOS+ and EOS- benralizumab 100 mg" arms. |
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.
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