Last updated: 11/08/2024 17:50:46

NUCALA Effectiveness Study

GSK study ID
213475
See study documents
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: 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
    Primary completion date:
    2023-01-03
    Observational study model:
    Cohort
    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)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Kuwait City, Kuwait, 70031
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    BogotA, Colombia, 100121
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    BogotA, Colombia, 110111
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Bogota, Colombia, 110131
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Bucaramanga, Colombia, 680003
    Status
    Study Complete
    Contact us

    Study documents

    Study report synopsis
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    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
    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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