Last updated: 11/07/2024 10:30:22
Nucala impact on clinical remission
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Evaluation of clinical remission endpoints in asthma patients treated with asthma biologics in real-world setting
Trial description: The primary purpose of the study is to quantify the proportion of participants for whom the following Clinical remission (CR) endpoint measurements were available for during the first year after initiation of respiratory biologics: Asthma exacerbations. Systemic corticosteroid use for asthma (that is, oral, injectable). Controller medication use for asthma (Inhaled Corticosteroids (ICS), ICS/ long acting beta-2 (β2) agonists (LABA), leukotriene receptor antagonist). Rescue medication use for asthma (Short-Acting β2 Agonist (SABA), ICS-SABA, ICS-LABA). Greater than or equal to (>=) 2 Asthma Control Tests (ACT). >= 2 Pulmonary function tests . Missed work/school due to asthma. The index date will be defined as the date of initiation of any of the respiratory biologics within the identification period. The follow-up period will be defined as the 12-month period after the index date or end of data availability (including end of care at Mayo or death).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Proportion of participants with greater than or equal to (>=) 1 asthma-related exacerbation
Timeframe: 12 months post-dose
Proportion of Participants with Greater than or equal to (>=) 1 SCS order/administration
Timeframe: 12 months post-dose
Proportion of Participants with greater than or equal to (>=)1 Inhaled Corticosteroids (ICS), ICS/ long acting β2 agonists (LABA) and/or leukotriene receptor antagonist
Timeframe: 12 months post-dose
Proportion of Participants with >= 1 SABA, ICS/ Short-Acting β2 Agonist (SABA), and/or ICS/LABA order/administration
Timeframe: 12 months post-dose
Proportion of Participants with Asthma Control Test (ACT), Asthma control questionnaire (ACQ), and Asthma Impairment and Risk Questionnaire (AirQ) values
Timeframe: 12 months post-dose
Proportion of Participants with >= 2 Pulmonary function tests (PFT)
Timeframe: 12 months post-dose
Proportion of Participants who Missed Work or School due to Asthma-related Symptoms
Timeframe: 12 months post-dose
Secondary outcomes:
Number of Participants Underage Group of 18–29, 30–39, 40–49, 50–59, 60–69,70-79, and 80+
Timeframe: 12 months post-dose
Number of Male and Female Participants
Timeframe: 12 months post-dose
Number of Participants From U.S. Census Bureau’s region designations
Timeframe: 12 months post-dose
Year of index date, race and ethnicity, height, weight, body mass index (BMI), and Eosinophil count
Timeframe: 12 months post-dose
Percentage of Participants with PFT, Asthma control assessments (ACT, ACQ, AirQ), Asthma-related exacerbations and Medication utilization
Timeframe: 12 months post-dose
General comorbidities, asthma-related comorbidities, All-cause and asthma-related Healthcare Resource Utilization HRU and Charlson Comorbidity Index score
Timeframe: 12 months post-dose
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2024-28-02
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
November 2023 to February 2024
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Greater than or equal to (>=) 1 respiratory biologic initiated during the participant identification period.
- >= 18 years of age as of the index year (at the time of respiratory biologic administration)
- Evidence of respiratory biologics during baseline from structured medication data tables and using a medication administered Natural language processing (NLP) model that extracts mention of drug administration from clinical notes prior to coming to the Mayo Clinic for care.
- >= 1 diagnosis of Hypereosinophilic Syndrome (HES) or Eosinophilic granulomatosis with polyangiitis (EGPA) in any position during the baseline period
Inclusion and exclusion criteria
Inclusion criteria:
- >= 18 years of age as of the index year (at the time of respiratory biologic administration)
- >= 12 months of clinical activity after the index date (follow-up period). Clinical activity will be defined as a patient having at least one clinical encounter at Mayo relating to asthma care within the time window.
- >= 1 diagnosis of asthma in any position during the baseline period.
Greater than or equal to (>=) 1 respiratory biologic initiated during the participant identification period.
Exclusion criteria:
- >= 1 diagnosis of Hypereosinophilic Syndrome (HES) or Eosinophilic granulomatosis with polyangiitis (EGPA) in any position during the baseline period
Evidence of respiratory biologics during baseline from structured medication data tables and using a medication administered Natural language processing (NLP) model that extracts mention of drug administration from clinical notes prior to coming to the Mayo Clinic for care.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Protocol
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
2024-28-02
Actual study completion date
2024-28-02
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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