Long Term Special Drug Use Investigation of Mepolizumab

Study Overview
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Brief Summary
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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

Official Title
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Nucala® Subcutaneous Injection Special Drug Use Investigation (Long-Term)

Conditions
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Asthma

Intervention / Treatment
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* Drug: NUCALA Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: No exclusion criteria
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with Bronchial asthma<br>Subjects with a refractory asthma whose symptoms are inadequately controlled despite receiving standard asthma medications will be enrolled | Drug: NUCALA Injection<br>* Single dose of NUCALA SC will be administered. Dose unit, daily dose frequency, date of administration will be at the investigator discretion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects whose data enetered on Electronic data capture (EDC) system | This includes the number of enrolled subjects whose data is entered in the EDC system. | Up to 3 years | 
| Incidence of adverse drug reaction | It will be calculated as the number of subjects having adverse drug reaction by total number of subjects on NUCALA treatment | Up to 3 years | 
| Number of subjects showing Response to the treatment | Response rate will be calculated as number of subjects showing response to the NUCALA treatment by total number of subjects on treatment | Up to Week 52 | 
| Number of subjects excluded from analysis due to exacerbation of asthma | Exacerbation of asthma includes, hospitalization, emergency room visit and usage of systemic steroids | Up to Week 52 | 
| Number of subjects having adverse drug reactions (ADR) | ADR is defined as , a response to a drug which is noxious and unintended, and which occurs 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 | 
| Number of subjects require priority investigation matter | Priority investigation matters include, Hypersensitivity reaction including anaphylaxis, infections, malignant tumour | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate assessed by global assessment of effectiveness | The response rate is the proportion of subjects assessed as effective based on the course of subjective symptoms, and course of clinical symptoms | Up to Week 52 | 
| Frequency of exacerbation of asthma | Frequency will be analyzed 52 weeks prior to the initiation of NUCALA treatment. Exacerbation of asthma includes, hospitalization, emergency room visit and usage of systemic steroids | Up to Week 52 | 
| Total score of Asthma Control Test (ACT) | Information on ACT will be recorded by subjects before the initiation of the therapy and at Week 12, Week 24 and Week 52 after administration. | Up to Week 52 | 
| Number of subjects having normal Peak Expiratory Flow (PEF) score | PEF is the Respiratory Function Test. It will be measured (at morning or evening) at the nearest time point of 1 week before and after the initiation of NUCALA treatment | Up to Week 54 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exacerbation, Mepolizumab, NUCALA