Last updated: 01/30/2025 09:40:42

Evaluate usability of self injection with mepolizumab autoinjector or prefilled syringe

GSK study ID
213655
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Long term usability of the self injection with the mepolizumab autoinjector or prefilled Syringe
Trial description: Mepolizumab has been associated with significant reductions in exacerbation rates of asthma and use of oral corticosteroids (OCS), especially in participants with elevated blood eosinophil counts. Mepolizumab was first approved in 2015 under the trade name NUCALA®, which was available as vial with lyophile and injected personally by a healthcare provider. In 2019, two new application forms – autoinjector (AI) and prefilled syringe (PFS) – received European market authorization. They can be administered directly by the participants themselves or by a caregiver, after the participant/caregiver have received training by a healthcare provider and the specific participant caregiver was considered adequate for self-application. This offers a paradigm shift from an office or hospital-based treatment approach to at home care and treatment. The NUCALA AI is a pen and injects the full dose of mepolizumab solved in liquid automatically after having been positioned on the skin and being activated by downwards pressure. The NUCALA PFS is a classical syringe with a fixed needle. The aims of this non-interventional study are to qualify as well as quantify (a) physicians and participants attitudes towards this novel approach in respiratory medicine, (b) to analyze outcomes in participants having been switched successfully or non-successfully to at home therapy with the NUCALA AI or PFS, and (c) to correlate attitudes and outcomes. Approximately 400 participants will be enrolled in this study and the study duration will be around 3 years. NUCALA is a registered trademark of GlaxoSmithKline (GSK) group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

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

Secondary outcomes:

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

Interventions:
Not applicable
Enrollment:
400
Primary completion date:
2024-30-01
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Asthma
Product
mepolizumab
Collaborators
University of Mainz
Study date(s)
November 2020 to January 2024
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • 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.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Study complete
Actual primary completion date
2024-30-01
Actual study completion date
2024-30-01

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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