Evaluate usability of self injection with mepolizumab autoinjector or prefilled syringe
Trial overview
Number of participants with overall treatment satisfaction with NUCALA autoinjector/prefilled syringe with a verbal rating (Likert) scale at 6 months
Timeframe: Up to 6 months
Number of participants with overall treatment satisfaction with NUCALA autoinjector/prefilled syringe with a verbal rating (Likert) scale at 12 months
Timeframe: Up to 12 months
Number of participants with overall treatment satisfaction with NUCALA autoinjector/prefilled syringe with the Injection Treatment Acceptance Questionnaire (ITAQ) at Baseline
Timeframe: Baseline (Day 0)
Number of participants with overall treatment satisfaction with NUCALA autoinjector/prefilled syringe with the ITAQ at 6 months
Timeframe: Up to 6 months
Number of participants with overall treatment satisfaction with NUCALA autoinjector/prefilled syringe with the ITAQ at 12 months
Timeframe: Up to 12 months
Number of participants with adherence to treatment at regular visits
Timeframe: Up to 12 months
Number of participants with reasons for non-adherence to treatment at regular visits
Timeframe: Up to 12 months
Number of participants with persistence to treatment at regular visits
Timeframe: Up to 12 months
Number of participants with reasons for non-persistence to treatment at regular visits
Timeframe: Up to 12 months
Change from Baseline in participant-related success factors for at home administration at 6 months
Timeframe: Baseline (Day 0) and up to 6 months
Change from Baseline in participant-related success factors for at home administration at 12 months
Timeframe: Baseline (Day 0) and up to 12 months
Change from Baseline in participant-related barriers to transition to at home administration at 6 months
Timeframe: Baseline (Day 0) and up to 6 months
Change from Baseline in participant-related barriers to transition to at home administration at 12 months
Timeframe: Baseline (Day 0) and up to 12 months
Quality of life assessed at Baseline
Timeframe: Baseline (Day 0)
Quality of life assessed at regular visits
Timeframe: Up to 12 months
Site characteristics at the start of the study
Timeframe: Baseline (Day 0)
Number of participants assessed by treatment patterns at the start of the study
Timeframe: Baseline (Day 0)
Change from Baseline in factors potentially influencing outcomes of at home treatment
Timeframe: Baseline (Day 0) and up to 12 months
Change from Baseline in physician-related factors influencing transition at home over the overall study period
Timeframe: Baseline (Day 0) and up to 36 months
Change from Baseline in physician-related factors between start and end of an individual participant’s observation period
Timeframe: Baseline (Day 0) and up to 12 months
- Written informed consent to documentation and processing of data in this study.
 - Adult participants (>=18 years of age).
 
- Participants with any contraindication according to the current Summary of Product Characteristics (SmPC) for NUCALA (example: hypersensitivity).
 - Participants with untreated parasitic infections.
 
- Written informed consent to documentation and processing of data in this study.
 - Adult participants (>=18 years of age).
 - On-treatment with NUCALA autoinjector/prefilled syringe at the investigator's office for 8 to 24 weeks, that is, having received at least three injections in the office (last injection at the time the participant is enrolled and released to at home treatment).
 - Starting treatment at home with self-injection/injection by the caregiver initiated.
 - Treatment with NUCALA lyophile for reconstitution for up to one year before study inclusion or naïve regarding biologic anti-asthma therapy.
 - In-label treatment according to the current European label.
 
- Participants with any contraindication according to the current Summary of Product Characteristics (SmPC) for NUCALA (example: hypersensitivity).
 - Participants with untreated parasitic infections.
 - Participants ever pre-treated with biologic anti-asthma therapy other than NUCALA.
 - Parallel participation in interventional studies or participation within the 8–24 weeks period on NUCALA autoinjector/prefilled syringe before the study.
 - Participants on-treatment with NUCALA>12 months.
 
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.