Last updated: 07/25/2024 07:00:07
NUCALA® for subcutaneous injection in pediatric participants with bronchial asthma
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Trial overview
Official title: NUCALA for Subcutaneous Injection Special Drug Use Investigation (Paediatric Bronchial Asthma)
Trial description: The objective of this study is to collect and assess information regarding the safety and effectiveness of NUCALA for subcutaneous injection in daily clinical practice in children aged 6 to <12 years with bronchial asthma (BA). This study will include pediatric participants, who receive NUCALA for the first time after the indication in children has been obtained, in order to treat BA (refractory asthma whose symptoms remain uncontrolled under the existing treatment), which is the indication of NUCALA. The observation period per participant will be one year (52 weeks) from the start date of NUCALA administration. Approximately 60 participants will be enrolled in this study and the study duration will be around 3 years and 9 months. NUCALA is a registered trademark of the GlaxoSmithKline (GSK) group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Type of adverse drug reactions (ADRs)
Timeframe: Up to 52 weeks
Number of participants with ADRs based on severity
Timeframe: Up to 52 weeks
Percentage of participants with ADRs
Timeframe: Up to 52 weeks
Percentage of responders based on global assessment of effectiveness
Timeframe: Up to 52 weeks
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
60
Primary completion date:
2025-01-04
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
July 2020 to October 2025
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
6 - 12 Years
Accepts healthy volunteers
No
- Inclusion criteria:
- Participants aged 6 to <12 years.
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion criteria:
- Participants aged 6 to <12 years.
- Participants receiving NUCALA for the first time for treatment of BA.
- An informed consent should be obtained from the participants or participant’s guardian. Exclusion criteria:
- Not applicable.
Trial location(s)
Study documents
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
Recruitment complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
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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