Trial · NCT01227278
A Study to Evaluate the Effectiveness of MEDI-563 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT01227278, Phase 2, Completed, MedImmune LLC; results first posted 2016-10-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Effectiveness of MEDI-563 in Subjects With Chronic Obstructive Pulmonary Disease (COPD). Trials, record NCT01227278. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01227278
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Effectiveness of MEDI-563 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
- NCT number
- NCT01227278
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 421 participants, actual
- Lead sponsor
- MedImmune LLC
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Placebo, Benralizumab 100 mg
- First posted
- 2010-10-25
- Last updated
- 2016-10-05
- Other registries' IDs
- eudract:2010-020127-52
- Results first posted
- 2016-10-05
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annualized Incidence Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) | Day 1 up to 393 | An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. Annualized Incidence Rate of Moderate or Severe AECOPD was assessed based on AECOPD data up to Day 393 (Rate = total number of moderate or severe AECOPD in each group/total person-year follow-up in each group). The severity of an exacerbation of COPD is defined as: a) Mild exacerbations, which require treatment with an increase in usual therapy, example (eg), increase use of short acting bronchodilators, b) Moderate exacerbations which require treatment with systemic corticosteroids, and or antibiotics and c) Severe exacerbations which require hospitalization. |
| Secondary | Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Day 1 up to 561 | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Day 561 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs reported below included both SAEs and non-serious AEs. |
| Secondary | Number of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) | Day 1 up to 393 | An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. |
| Secondary | Percentage of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) | Day 1 up to 393 | An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. |
| Secondary | Annual Incidence Rate of Hospitalization Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) | Day 1 up to 393 | An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. Annualized Incidence Rate of hospitalization due to AECOPD was calculated as Rate = total number of hospitalizations/ total person years. |
| Secondary | Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Domain Scores at Day 393 | Baseline, Day 393 | The SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question's response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score are derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status. |
| Secondary | Percentage of Participants With Improvement in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total Score | Day 393 | SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question's response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score were derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status. Percentage of participants with 4-point, 8-point and 12-point change from baseline in SGRQ-C total score were observed. |
| Secondary | Change From Baseline in Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) Domain Scores at Day 393 | Baseline, Day 393 | The CRQ-SAS is a self-administered questionnaire which consist of 20 items across four domains: dyspnea (5 items), fatigue (4 items), emotional function (7 items), and mastery (4 items). Participants rated their experience on a 7-point scale in response to each item ranging from 1 (maximum impairment) to 7 (no impairment). Individual items were equally weighted, and domain scores were calculated as the mean of all items within each domain; domain score range: 1 (maximum impairment) to 7 (no impairment). |
| Secondary | Percentage of Participants With a 0.5-Point Improvement in Chronic Respiratory Questionnaire Self-administered Standardized Format (CRQ-SAS) Domain Scores at Day 393 | Day 393 | The CRQ-SAS is a self-administered questionnaire which consist of 20 items across four domains: dyspnea (5 items), fatigue (4 items), emotional function (7 items), and mastery (4 items). Participants rated their experience on a 7-point scale in response to each item ranging from 1 (maximum impairment) to 7 (no impairment). Individual items were equally weighted, and domain scores were calculated as the mean of all items within each domain; domain score range: 1 (maximum impairment) to 7 (no impairment). Participants with 0.5 point improvement from baseline in the domain scores were observed. |
| Secondary | Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Scores at Day 393 | Baseline, Day 393 | The BODE index is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the modified medical research council (MMRC) dyspnea scale and the 6-minute walk test. The MMRC dyspnea scale is a 5-point scale that measures the level of dyspnea (trouble breathing) experienced by participants where score range is 0 (none) to 4 (very severe ). BODE score is derived into a score range of 0 (healthy) to 10 (severe COPD). |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Annualized Incidence Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) | Day 1 up to 393 | The per protocol (PP) population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. | AECOPD events/person-year | NUMBER |
| SECONDARY | Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Day 1 up to 561 | The safety population included all participants who received at least one dose of investigational drug. | participants | NUMBER |
| SECONDARY | Number of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) | Day 1 up to 393 | The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. | participants | NUMBER |
| SECONDARY | Percentage of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) | Day 1 up to 393 | The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. | percentage of participants | NUMBER |
| SECONDARY | Annual Incidence Rate of Hospitalization Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) | Day 1 up to 393 | The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. | hospitalizations/person-year | NUMBER |
| SECONDARY | Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Domain Scores at Day 393 | Baseline, Day 393 | The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively. | units on scale | MEAN |
| SECONDARY | Percentage of Participants With Improvement in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total Score | Day 393 | The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) Domain Scores at Day 393 | Baseline, Day 393 | The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively. | units on scale | MEAN |
| SECONDARY | Percentage of Participants With a 0.5-Point Improvement in Chronic Respiratory Questionnaire Self-administered Standardized Format (CRQ-SAS) Domain Scores at Day 393 | Day 393 | The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Scores at Day 393 | Baseline, Day 393 | The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively. | units on scale | MEAN |
Source ClinicalTrials.gov
Results by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Annualized Incidence Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) | Placebo | 0.92 | 95% Confidence Interval 0.67 to 1.25 | AECOPD events/person-year | |
| Annualized Incidence Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) | Benralizumab 100 mg | 0.95 | 95% Confidence Interval 0.68 to 1.29 | AECOPD events/person-year | |
| Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Placebo | TEAEs | 41 | participants | |
| Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Benralizumab 100 mg | TEAEs | 45 | participants | |
| Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Placebo | TESAEs | 9 | participants | |
| Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Benralizumab 100 mg | TESAEs | 14 | participants | |
| Number of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) | Placebo | 5 | participants | ||
| Number of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) | Benralizumab 100 mg | 2 | participants | ||
| Percentage of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) | Placebo | 11.9 | percentage of participants | ||
| Percentage of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) | Benralizumab 100 mg | 5.0 | percentage of participants |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 50 | |
| Overall Study | STARTED | Benralizumab 100 mg | 51 | |
| Overall Study | COMPLETED | Placebo | 45 | |
| Overall Study | COMPLETED | Benralizumab 100 mg | 43 | |
| Overall Study | NOT COMPLETED | Placebo | 5 | |
| Overall Study | NOT COMPLETED | Benralizumab 100 mg | 8 |
Source ClinicalTrials.gov
Adverse events164
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 50 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Benralizumab 100 mg | 1 | 51 | 1 |
| other | Angina pectoris | Cardiac disorders | Placebo | 0 | 50 | 0 |
| other | Angina pectoris | Cardiac disorders | Benralizumab 100 mg | 2 | 51 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 1 | 50 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Benralizumab 100 mg | 1 | 51 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 4 | 50 | 4 |
| other | Abdominal pain upper | Gastrointestinal disorders | Benralizumab 100 mg | 0 | 51 | 0 |
| other | Constipation | Gastrointestinal disorders | Placebo | 0 | 50 | 0 |
| other | Constipation | Gastrointestinal disorders | Benralizumab 100 mg | 2 | 51 | 2 |
1 to 10 of 164Source ClinicalTrials.gov
See all 164 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Benralizumab 100 mg | ||
| Total, other adverse events | Placebo | 41 | 50 |
| Total, other adverse events | Benralizumab 100 mg | 44 | 51 |
| Total, serious adverse events | Placebo | 9 | 50 |
| Total, serious adverse events | Benralizumab 100 mg | 14 | 51 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Benralizumab 100 mg vs Placebo: Number of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) | Trial comparisons |
| Benralizumab 100 mg vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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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Read this trial from software.
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