Last updated: 11/08/2024 17:50:46
NUCALA Effectiveness Study
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: NUCALA Effectiveness Study (NEST) in Emerging Markets
Trial description: Mepolizumab (NUCALA®) is a first-in-class therapy for the treatment of Severe Eosinophilic Asthma. This is a bi-directional, self-controlled cohort study with a clinical diagnosis of severe eosinophilic asthma participants. The purpose of this study is to compare the overall rates of clinically significant asthma exacerbations in the pre-exposure and the 12-month post-exposure period with mepolizumab treatment. This study aims to evaluate clinical outcomes, healthcare resource utilization, associated direct medical cost, and participants impact in real world clinical practice to provide a more complete understanding of the value of mepolizumab for participants in routine clinical practice with severe asthma. Participants who have 12 months historical data prior to the study index date will be enrolled, where index is defined as mepolizumab initiation in normal clinical practice. NUCALA is a registered trademark of the GlaxoSmithKline Group of Companies.
Primary purpose:
Other
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Rate of clinically significant asthma exacerbations
Timeframe: Up to 12 months
Secondary outcomes:
Medication possession ratio
Timeframe: Up to 12 months
Proportion of days covered
Timeframe: Up to 12 months
Number of participants with treatment discontinuation by reasons
Timeframe: Up to 12 months
Number of participants with asthma exacerbations requiring emergency department visit
Timeframe: Up to 12 months
Number of participants with asthma exacerbations requiring hospitalization
Timeframe: Up to 12 months
Proportion of participants experiencing one or more asthma exacerbations requiring emergency department visit
Timeframe: Up to 12 months
Proportion of participants experiencing one or more asthma exacerbations requiring hospitalization
Timeframe: Up to 12 months
Change from Baseline in daily maintenance oral corticosteroid dose
Timeframe: Baseline (pre-exposure) and up to 12 months post-exposure
Change from Baseline in total oral corticosteroid dose
Timeframe: Baseline (pre-exposure) and up to 12 months post-exposure
Number of participants with Adverse Events (AEs) and Serious AEs (SAEs)
Timeframe: Up to 12 months
Number of participants with asthma hospitalizations
Timeframe: Up to 12 months
Duration of asthma related hospitalization
Timeframe: Up to 12 months
Number of participants with intensive care unit events
Timeframe: Up to 12 months
Duration of intensive care unit stay
Timeframe: Up to 12 months
Number of participants with asthma emergency department events
Timeframe: Up to 12 months
Number of participants with outpatient events
Timeframe: Up to 12 months
Number of participants with asthma medications
Timeframe: Up to 12 months
Number of participants with hospital readmission
Timeframe: Up to 12 months
Interventions:
Drug: Mepolizumab
Enrollment:
0
Observational study model:
Cohort
Primary completion date:
2023-01-03
Time perspective:
Prospective
Clinical publications:
Riyad Omar Al-Lehebi, Mona Al Ahmad, Venkata Nagarjuna Maturu, Alejandra Galeano Mesa, Bassam Mahboub, Elizabeth Garcia, Patricia Fernandez, Claudia Soares, Gabriela Abreu, Debora Dos Santos, Juliana Queiroz, Alejandro Raimondi, Maria Laucho-Contreras, Saeed Noibi, Gur Levy, Sevim Bavbek. Real-World Effectiveness of Mepolizumab in Severe Asthma: Results from the Multi-country, Self-controlled Nucala Effectiveness Study (NEST). Advances in therapy. 2024-Aug-31
PMID: 39215767
DOI: 10.1007/s12325-024-02967-x
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
November 2021 to April 2024
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Informed Consent: Prior to commencing any study related activities, participants must be able and willing to provide written informed consent. This criterion will depend of ethical requirements in each country.
- Participants must already have a physician indication to start treatment with mepolizumab or have already started mepolizumab treatment as an indication to treat severe asthma. Any country that similarly to Turkey has any ethic restriction aspects regarding the participants enrollment on the initiation date of mepolizumab, will only enroll participants already using mepolizumab as an inclusion criterion.
- Mepolizumab injection during the 12 months prior to enrollment for the prospective approach.
- Participation in a clinical trial in which the treatment regimen and/or monitoring is dictated by a protocol during the previous 12 months.
Inclusion and exclusion criteria
Inclusion criteria:
- Informed Consent: Prior to commencing any study related activities, participants must be able and willing to provide written informed consent. This criterion will depend of ethical requirements in each country.
- Participants must already have a physician indication to start treatment with mepolizumab or have already started mepolizumab treatment as an indication to treat severe asthma. Any country that similarly to Turkey has any ethic restriction aspects regarding the participants enrollment on the initiation date of mepolizumab, will only enroll participants already using mepolizumab as an inclusion criterion.
- Paper or Electronic Medical Record available for 12 months prior to index date.
- Adults aged 18 years or over.
Exclusion criteria:
- Mepolizumab injection during the 12 months prior to enrollment for the prospective approach.
- Participation in a clinical trial in which the treatment regimen and/or monitoring is dictated by a protocol during the previous 12 months.
- Incomplete medical records or evidence of inconsistent adherence to Mepolizumab treatment.
Trial location(s)
Study documents
Study report synopsis
Available language(s): English
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
Finalized
Actual primary completion date
2023-01-03
Actual study completion date
2024-26-04
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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