Last updated: 09/30/2024 15:10:10

NUCALA Effectiveness Study Argentina

GSK study ID
221418
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) Argentina
Trial description: This study aims to evaluate clinical outcomes, healthcare resource utilization, associated direct medical cost, and patients’ impact in real world clinical practice to provide a more complete understanding of the value of mepolizumab for participants with routine clinical practice with severe asthma.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Overall rate of Clinically Significant Asthma Exacerbations

Timeframe: 12 months pre-dose and 12 months post-dose

Secondary outcomes:

Adherence for Use of Mepolizumab in Terms of Medication Possession Ratio (MPR)

Timeframe: 12 months post-dose

Persistence for Use of Mepolizumab in Terms of Proportion of Days Covered (PDC)

Timeframe: 12 months post-dose

Duration of Mepolizumab Therapy

Timeframe: 12 months post-dose

Number of Participants with Discontinuation and Reasons for Discontinuation of Mepolizumab

Timeframe: 12 months post-dose

Rate of Asthma Exacerbations Requiring Either Emergency Department (ED) Visit or Hospital Admission (With and Without Intensive Care Unit [ICU] Stay)

Timeframe: 12 months per-dose and 12 months post-dose

Proportion of Participants with 1 or More Exacerbations Requiring Either Emergency Department (ED) Visit or Hospital Admission (With and Without ICU Stay)

Timeframe: 12 months per-dose and 12 months post-dose

Rate of Asthma Exacerbations Requiring Hospital Admission (With and Without Intensive Care Unit [ICU] Stay)

Timeframe: 12 months per-dose and 12 months post-dose

Proportion of Participants with 1 or More Exacerbations Requiring Hospital Admission (With and Without ICU Stay)

Timeframe: 12 months per-dose and 12 months post-dose

Change from Baseline in Daily Maintenance Oral Corticosteroids (OCS) Dose

Timeframe: Baseline and at 12 months post-dose

Change from Baseline in Total OCS Dose

Timeframe: Baseline and at 12 months post-dose

Number and Length of Asthma Related Hospitalizations and ICU Events

Timeframe: 12 months per-dose and 12 months post-dose

Number and Length of Asthma Related ED Events

Timeframe: 12 months per-dose and 12 months post-dose

Number and Length of Asthma Related Outpatient Events

Timeframe: 12 months per-dose and 12 months post-dose

Number of Participants with Medication for Asthma

Timeframe: 12 months per-dose and 12 months post-dose

Number of Participants with Asthma Related Hospital Readmission

Timeframe: 12 months per-dose and 12 months post-dose

Number of Participants with Comorbidities using the Charlson Comorbidity Index

Timeframe: 12 months per-dose and 12 months post-dose

Rate of Health Care Professional (HCP) Satisfaction with Mepolizumab Treatment

Timeframe: 12 months post-dose

Change in Forced Expiratory Volume in One Second (FEV1)

Timeframe: 12 months post-dose

Change in Forced Vital Capacity (FVC)

Timeframe: 12 months post-dose

Change in FEV1/FVC

Timeframe: 12 months post-dose

Change in Peripheral Blood Eosinophils

Timeframe: Baseline and 12 months post-dose

Change from Baseline in Asthma Control as Measured by an Asthma Control Test (ACT)

Timeframe: At Baseline, 6 months and 12 months post-dose

Change from Baseline in Improvement in Health-Related Quality of Life (HRQoL)

Timeframe: Baseline and 12 months post-dose

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2023-01-10
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
July 2023 to October 2023
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Prior to commencing any study related activities, participants
  • must be able and willing to provide written informed consent.
  • 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:
  • Prior to commencing any study related activities, participants must be able and willing to provide written informed consent.
  • 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.
  • Paper or EMR available for 12-months prior to index date.
Exclusion criteria:
  • Participation in a clinical trial in which the treatment regimen and/or monitoring is dictated by a protocol during the previous 12 months.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Protocol
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
2023-01-10
Actual study completion date
2023-01-10

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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