N/A
Completed N=1,061
Long Term Special Drug Use Investigation of Mepolizumab
Source: ClinicalTrials.gov NCT03028480 ↗Enrolled (actual)
1,061
Serious AEs
0.9%
Results posted
Sep 2024
Primary outcomePrimary: Number of Participants Whose Data Entered on Electronic Data Capture (EDC) System — 1040 Participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Whose Data Entered on Electronic Data Capture (EDC) System |
1040 | — |
| PRIMARY Percentage of Participants With Adverse Drug Reaction (ADR) |
4.1 | — |
| PRIMARY Number of Participants Showing Response to the Treatment |
866 | — |
| PRIMARY Number of Participants Excluded From Analysis Due to Exacerbation of Asthma |
16 | — |
| PRIMARY Number of Participants With Adverse Drug Reactions (ADR) |
42 | — |
| PRIMARY Percentage of Participants With Occurrences of Safety Specifications and Priority Investigation Matters |
1.2; 0.3; 0.2 | — |
| SECONDARY Response Rate Assessed by Global Assessment of Effectiveness |
90.3 | — |
| SECONDARY Rate of Exacerbation of Asthma |
0.4; 0.1; 0.9; 0.2; 3.2; 0.7 | — |
| SECONDARY Total Score of Asthma Control Test (ACT) at Indicated Time Points |
16.2; 20.5; 20.9; 21.4 | — |
| SECONDARY Mean Peak Expiratory Flow (PEF) at Indicated Time Points |
304.4; 333.7; 334.2; 358.9 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03028480). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.