Last updated: 08/24/2023 17:30:56
Impact of NUCALA® on participants with asthma and comorbid sinus surgery
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Real-World Clinical and Economic Impact of Nucala® Initiation among Adult Patients with Severe Asthma and Comorbid Chronic Rhinosinusitis, in the Presence of Nasal Polyps and Prior Sinus Surgery, in the US
Trial description: This study will investigate the clinical effectiveness and economic outcomes of NUCALA (mepolizumab) treatment among participants with severe asthma, in the presence of comorbid chronic rhinosinusitis (CRS), nasal polyps (NP) and sinus surgery. NUCALA is a registered trademark of GlaxoSmithKline group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants experiencing asthma exacerbations before and after initiation of NUCALA treatment
Timeframe: 12 months pre and post-index date
Asthma-related healthcare resource utilization before and after initiation of NUCALA treatment
Timeframe: 12 months pre and post-index date
Asthma-related healthcare costs before and after initiation of NUCALA treatment
Timeframe: 12 months pre and post-index date
Asthma exacerbation-related healthcare resource utilization before and after initiation of NUCALA treatment
Timeframe: 12 months pre and post-index date
Asthma exacerbation-related healthcare costs before and after initiation of NUCALA treatment
Timeframe: 12 months pre and post-index date
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2021-17-12
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Jared Silver, Arijita Deb, François Laliberté, Chi Gao, Neil Bhattacharyya. Real-world effectiveness of mepolizumab in severe asthma and chronic rhinosinusitis in the United States: impact of comorbidity and sinus surgery.. International forum of allergy & rhinology. 2023-Jun-26;
DOI :10.1002/alr.23220
PMID: 37365852
Medical condition
Nasal Polyps
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
September 2021 to December 2021
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Greater than or equal to 1 medical claim with primary or secondary diagnosis of asthma at any time during the study period
- Greater than or equal to 2 pharmacy or medical claims for NUCALA after first medical claim for asthma, between 04-Nov-2016 and 01-Mar-2019 (the first prescription or medical claim for NUCALA defines the index date)
- Greater than or equal to 1 medical claim with primary or secondary diagnosis of the following conditions at any time during the study period: Active tuberculosis; Cystic fibrosis
- Exposure to any biologics indicated for asthma during pre-treatment period.
Inclusion and exclusion criteria
Inclusion criteria:
- Greater than or equal to 1 medical claim with primary or secondary diagnosis of asthma at any time during the study period
- Greater than or equal to 2 pharmacy or medical claims for NUCALA after first medical claim for asthma, between 04-Nov-2016 and 01-Mar-2019 (the first prescription or medical claim for NUCALA defines the index date)
- Greater than or equal to 18 years of age at the index date
- Greater than or equal to 12 months of continuous eligibility prior to the index date
- Greater than or equal to 12 months of continuous eligibility after the index date.
Exclusion criteria:
- Greater than or equal to 1 medical claim with primary or secondary diagnosis of the following conditions at any time during the study period: Active tuberculosis; Cystic fibrosis
- Exposure to any biologics indicated for asthma during pre-treatment period.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Study report synopsis
Available language(s): English
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
2021-17-12
Actual study completion date
2021-17-12
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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