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This study is a special drug use investigation program of NUCALA (a brand name for Mepolizumab) administered subcutaneously (SC). In this study the information regarding the safety and effectiveness of long term use of NUCALA after subcutaneous injection will be collected from Asthma subjects in daily clinical practice. The observation period per subject will be 52 weeks from the initiation of NUCALA treatment with follow-up investigation for 2 years after the observation period. NUCALA is a registered trademark of the GlaxoSmithKline [GSK] group of companies
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with Bronchial asthma | Subjects with a refractory asthma whose symptoms are inadequately controlled despite receiving standard asthma medications will be enrolled |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NUCALA Injection | Drug | Single dose of NUCALA SC will be administered. Dose unit, daily dose frequency, date of administration will be at the investigator discretion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Whose Data Entered on Electronic Data Capture (EDC) System | The number of participants whose data was entered in the EDC system up to 14 days from the initiation of NUCALA treatment (Day 1) has been presented. | Up to 14 days from the initiation of NUCALA treatment (Day 1) |
| Percentage of Participants With Adverse Drug Reaction (ADR) | ADR is defined as a response to a drug which is noxious and unintended, and which occurred at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function. Percentage of participants with ADR were calculated as the number of participants having a particular ADR divided by total number of participants on NUCALA treatment*100. Percentage values are rounded-off. | Up to 3 years |
| Number of Participants Showing Response to the Treatment | The number of participants who showed response to the bronchial asthma treatment has been presented. | Up to 1 year |
| Number of Participants Excluded From Analysis Due to Exacerbation of Asthma | The number of participants excluded from analysis due to exacerbation of asthma has been presented. | Up to 1 year |
| Number of Participants With Adverse Drug Reactions (ADR) | ADR is defined as a response to a drug which is noxious and unintended, and which occurred at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function. | Up to 3 years |
| Percentage of Participants With Occurrences of Safety Specifications and Priority Investigation Matters |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate Assessed by Global Assessment of Effectiveness | Response rate is the percentage of participants assessed as "effective" based on the course of subjective symptoms and clinical symptoms. Response rate was calculated as number of participants showing response to the NUCALA treatment divided by total number of participants on treatment*100. Percentage values are rounded-off. Response rate and corresponding 95% confidence interval were reported. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms are inadequately controlled despite receiving standard asthma medications)
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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A total of 1061 participants were enrolled in the study (Enrolled Set included participants registered within the enrollment period specified in the protocol).
This non-interventional study aims to collect and assess information regarding the safety and effectiveness of long-term use of NUCALA in asthma participants in daily clinical practice.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Bronchial Asthma | Participants receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms were inadequately controlled despite receiving standard asthma medications) in clinical practice were enrolled in this study. No study treatment was administered during conduct of this study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline Characteristic data are reported for the Safety Analysis Set which consisted of the participants fixed in the case report form. It includes participants that do not fall under the safety analysis exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Bronchial Asthma | Participants receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms were inadequately controlled despite receiving standard asthma medications) in clinical practice were enrolled in this study. No study treatment was administered during conduct of this study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Whose Data Entered on Electronic Data Capture (EDC) System | The number of participants whose data was entered in the EDC system up to 14 days from the initiation of NUCALA treatment (Day 1) has been presented. | Enrolled Set included participants registered within the enrollment period specified in the protocol. | Posted | Count of Participants | Participants | Up to 14 days from the initiation of NUCALA treatment (Day 1) |
|
All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to 3 years
All-cause mortality, serious and non-serious ADRs were reported for Safety Analysis Set (1027) since 34 participants from Enrolled Set (1061) were not included in safety analysis as their CRF were not collected/fall under safety analysis exclusion criteria. Safety Analysis Set consisted of participants fixed in CRF. It includes participants that do not fall under safety analysis exclusion criteria. Only serious and non-serious ADR were collected but not all adverse events as planned per Protocol
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants With Bronchial Asthma | Participants receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms were inadequately controlled despite receiving standard asthma medications) in clinical practice were enrolled in this study. No study treatment was administered during conduct of this study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 8, 2022 | May 22, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 21, 2023 | May 22, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C434107 | mepolizumab |
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Safety specifications and priority investigation matters included hypersensitivity reaction including anaphylaxis, infections, and malignant tumor. The percentage of participants with occurrences of safety specifications and priority investigation matters have been reported. Percentage values are rounded-off. |
| Up to 3 years |
| Up to 1 year |
| Rate of Exacerbation of Asthma | Asthma exacerbation was defined as new or increased asthma symptoms (wheezing, coughing, dyspnea, chest tightness, and/or nighttime awakenings due to these symptoms) that resulted in hospitalization, emergency room visit and usage of systemic steroids. Exacerbation rate was defined as number of asthma exacerbations divided by total person-year (52 weeks were converted to 1 year). Data for exacerbations requiring hospitalization, emergency room visit, and use of systemic corticosteroid have been presented. | 52 weeks before the initiation of NUCALA treatment (Day 1) and at Week 52 post-treatment |
| Total Score of Asthma Control Test (ACT) at Indicated Time Points | The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled) with higher scores indicating better control. Total ACT score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant's asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant's asthma is likely to be well controlled. Baseline was defined as within 8 weeks prior to initiation of NUCALA treatment (Day 1). | Baseline, Weeks 12, 24 and 52 after the initiation of NUCALA treatment (Day 1) |
| Mean Peak Expiratory Flow (PEF) at Indicated Time Points | Peak Expiratory Flow is a person's maximum speed of expiration. PEF was measured using an electronic peak expiratory flow device (ePEF) at Baseline (Day 1), and at Weeks 12, 24, and 54 after the initiation of NUCALA treatment. Baseline was defined as within 8 weeks prior to initiation of NUCALA treatment (Day 1). | Baseline, Weeks 12, 24 and 52 after the initiation of NUCALA treatment (Day 1) |
| Case report forms were not collected |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Percentage of Participants With Adverse Drug Reaction (ADR) | ADR is defined as a response to a drug which is noxious and unintended, and which occurred at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function. Percentage of participants with ADR were calculated as the number of participants having a particular ADR divided by total number of participants on NUCALA treatment*100. Percentage values are rounded-off. | Safety Analysis Set consisted of the participants fixed in the case report form (CRF). It included participants that do not fall under the safety analysis exclusion criteria. | Posted | Number | Percentage of participants | Up to 3 years |
|
|
|
| Primary | Number of Participants Showing Response to the Treatment | The number of participants who showed response to the bronchial asthma treatment has been presented. | Effectiveness Analysis Set consisted of the participants included in safety analysis, participants that do not fall under the participants excluded from efficacy analysis. | Posted | Count of Participants | Participants | Up to 1 year |
|
|
|
| Primary | Number of Participants Excluded From Analysis Due to Exacerbation of Asthma | The number of participants excluded from analysis due to exacerbation of asthma has been presented. | Enrolled Set included participants registered within the enrollment period. | Posted | Count of Participants | Participants | Up to 1 year |
|
|
|
| Primary | Number of Participants With Adverse Drug Reactions (ADR) | ADR is defined as a response to a drug which is noxious and unintended, and which occurred at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function. | Safety Analysis Set consisted of the participants fixed in the case report form. It included participants that do not fall under the safety analysis exclusion criteria. | Posted | Count of Participants | Participants | Up to 3 years |
|
|
|
| Primary | Percentage of Participants With Occurrences of Safety Specifications and Priority Investigation Matters | Safety specifications and priority investigation matters included hypersensitivity reaction including anaphylaxis, infections, and malignant tumor. The percentage of participants with occurrences of safety specifications and priority investigation matters have been reported. Percentage values are rounded-off. | Safety Analysis Set consisted of the participants fixed in the case report form. It included participants that do not fall under the safety analysis exclusion criteria. | Posted | Number | Percentage of participants | Up to 3 years |
|
|
|
| Secondary | Response Rate Assessed by Global Assessment of Effectiveness | Response rate is the percentage of participants assessed as "effective" based on the course of subjective symptoms and clinical symptoms. Response rate was calculated as number of participants showing response to the NUCALA treatment divided by total number of participants on treatment*100. Percentage values are rounded-off. Response rate and corresponding 95% confidence interval were reported. | Effectiveness Analysis Set consisted of the participants included in safety analysis, participants that do not fall under the participants excluded from efficacy analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 1 year |
|
|
|
| Secondary | Rate of Exacerbation of Asthma | Asthma exacerbation was defined as new or increased asthma symptoms (wheezing, coughing, dyspnea, chest tightness, and/or nighttime awakenings due to these symptoms) that resulted in hospitalization, emergency room visit and usage of systemic steroids. Exacerbation rate was defined as number of asthma exacerbations divided by total person-year (52 weeks were converted to 1 year). Data for exacerbations requiring hospitalization, emergency room visit, and use of systemic corticosteroid have been presented. | Effectiveness Analysis Set consisted of the participants included in safety analysis, participants that do not fall under the participants excluded from efficacy analysis. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Number | Asthma exacerbations per person-year | 52 weeks before the initiation of NUCALA treatment (Day 1) and at Week 52 post-treatment |
|
|
|
| Secondary | Total Score of Asthma Control Test (ACT) at Indicated Time Points | The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled) with higher scores indicating better control. Total ACT score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant's asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant's asthma is likely to be well controlled. Baseline was defined as within 8 weeks prior to initiation of NUCALA treatment (Day 1). | Effectiveness Analysis Set consisted of the participants included in safety analysis, participants that do not fall under the participants excluded from efficacy analysis. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Weeks 12, 24 and 52 after the initiation of NUCALA treatment (Day 1) |
|
|
|
| Secondary | Mean Peak Expiratory Flow (PEF) at Indicated Time Points | Peak Expiratory Flow is a person's maximum speed of expiration. PEF was measured using an electronic peak expiratory flow device (ePEF) at Baseline (Day 1), and at Weeks 12, 24, and 54 after the initiation of NUCALA treatment. Baseline was defined as within 8 weeks prior to initiation of NUCALA treatment (Day 1). | Effectiveness Analysis Set consisted of the participants included in safety analysis, participants that do not fall under the participants excluded from efficacy analysis. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Liters/minute | Baseline, Weeks 12, 24 and 52 after the initiation of NUCALA treatment (Day 1) |
|
|
|
| 3 |
| 1,027 |
| 9 |
| 1,027 |
| 33 |
| 1,027 |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
|
| Intraductal papillary-mucinous carcinoma of pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
|
| Myasthenia gravis | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Optic neuropathy | Eye disorders | MedDRA 26.0 | Systematic Assessment |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Chronic eosinophilic rhinosinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Chronic eosinophilic rhinosinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDRA 26.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
|
| Exacerbations requiring emergency room visits: 52 weeks before the initiation of NUCALA treatment |
|
|
| Exacerbations requiring emergency room visits: at Week 52 post-treatment |
|
|
| Exacerbations requiring use of systemic corticosteroid:52weeks before initiation of NUCALA treatment |
|
|
| Exacerbations requiring the use of systemic corticosteroid: at Week 52 post-treatment |
|
|
|
| 24 weeks after the initiation of NUCALA treatment |
|
|
| 52 weeks after the initiation of NUCALA treatment |
|
|
|
| 24 weeks after the initiation of NUCALA treatment |
|
|
| 52 weeks after the initiation of NUCALA treatment |
|
|