Nucala® Subcutaneous Injection Special Drug Use Investigation (Long-Term)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- GlaxoSmithKline
- Enrollment
- 1,000
- Primary Endpoint
- Number of Participants Whose Data Entered on Electronic Data Capture (EDC) System
Study Overview
Brief Summary
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
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Subjects with Bronchial asthma
Subjects with a refractory asthma whose symptoms are inadequately controlled despite receiving standard asthma medications will be enrolled
Intervention: NUCALA Injection (Drug)
Outcomes
Primary Outcomes
Number of Participants Whose Data Entered on Electronic Data Capture (EDC) System
Time Frame: Up to 14 days from the initiation of NUCALA treatment (Day 1)
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.
Percentage of Participants With Adverse Drug Reaction (ADR)
Time Frame: Up to 3 years
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.
Number of Participants Showing Response to the Treatment
Time Frame: Up to 1 year
The number of participants who showed response to the bronchial asthma treatment has been presented.
Number of Participants Excluded From Analysis Due to Exacerbation of Asthma
Time Frame: Up to 1 year
The number of participants excluded from analysis due to exacerbation of asthma has been presented.
Number of Participants With Adverse Drug Reactions (ADR)
Time Frame: Up to 3 years
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 Occurrences of Safety Specifications and Priority Investigation Matters
Time Frame: Up to 3 years
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.
Secondary Outcomes
- Response Rate Assessed by Global Assessment of Effectiveness(Up to 1 year)
- Rate of Exacerbation of Asthma(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(Baseline, Weeks 12, 24 and 52 after the initiation of NUCALA treatment (Day 1))
- Mean Peak Expiratory Flow (PEF) at Indicated Time Points(Baseline, Weeks 12, 24 and 52 after the initiation of NUCALA treatment (Day 1))