Last updated:  09/14/2020 14:10:11
Impact of Nucala on ExacerbationsNucala
Clinicaltrials.gov ID 
Not applicable
EudraCT ID 
Not applicable
EU CT Number 
Not applicable
Trial status 
                  Study complete
                
Study complete
Trial overview
Official title: Impact of Nucala on Exacerbations in a Managed Care Claims Database
Trial description: While biologic medications for severe asthma may be costly, they have a unique place in therapy for severe uncontrolled subjects and may reduce the burden of disease for those subjects that remain refractory despite current therapy. It is important for payers, providers, subjects and other healthcare stakeholders to understand the effectiveness of these biologic medications in the real world setting. This is a retrospective observational analysis of administrative claims using the Optum Research Database (ORD). Using the claims data, subjects within commercial and Medicare Advantage health plans treated with mepolizumab will be identified during the identification period (ID period) from 01-January-2015 through 31-March-2017. The index date will be set as the date of first new prescription fill for mepolizumab in which there were no previous fill in the 12 months period prior to the new fill. Asthma-related exacerbations and exacerbation-related health care costs will be measured in the 12 month Baseline and the 12 month period following index date (follow-up period). Subject demographics and Baseline clinical characteristics will be measured in the 12 month period prior to index date, including index date (Baseline period). The primary objective of the study is to compare the changes in the total number of asthma exacerbations among subjects receiving mepolizumab in the year before initiating Nucala to the year after.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of asthma-related exacerbations
Timeframe: Up to 24 months
Change from Baseline to Follow up in the number of exacerbations
Timeframe: Baseline to 24 months
Secondary outcomes: 
Asthma exacerbation-related health care costs
Timeframe: Up to 24 months
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2019-26-03
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Ortega H, Hahn B, Bogart M, Bell C, Bancroft T, Chastek B, Llanos JP. Impact of mepolizumab on exacerbations in severe asthma: results from a US insurance claims data base. Allergy Asthma Proc. 2020;41(4):341-347
DOI: 10.2500/aap.2020.41.200043
PMID: 32867888
- Treatment with mepolizumab between 01 January 2015 and 31 March 2017 (identification period).
 - A diagnosis of asthma defined as having at least 1 non-diagnostic medical claim with an International Classification of Diseases (ICD), Ninth or Tenth Revision, Clinical Modification (CM) (ICD-9-CM/ICD-10-CM) diagnosis code for asthma in the primary position (ICD-9-CM: 493.x; ICD-10-CM: J45.x) during the baseline period.
 
- Subjects with mepolizumab during the Baseline (excluding the index date).
 - Subjects with an asthma-related biologic (e.g. omalizumab, reslizumab, benralizumab) during the 12 month Baseline period
 
Inclusion and exclusion criteria
Inclusion criteria:
- Treatment with mepolizumab between 01 January 2015 and 31 March 2017 (identification period).
 - A diagnosis of asthma defined as having at least 1 non-diagnostic medical claim with an International Classification of Diseases (ICD), Ninth or Tenth Revision, Clinical Modification (CM) (ICD-9-CM/ICD-10-CM) diagnosis code for asthma in the primary position (ICD-9-CM: 493.x; ICD-10-CM: J45.x) during the baseline period.
 - Commercial or Medicare Advantage enrollee.
 - At least 12 years of age as of index.
 - Continuously enrolled with medical and pharmacy benefits during the 12-month Baseline and 12-month Follow-up periods.
 - A minimum of 2 doses of the index drug in the first 180 days of the 12 month follow-up period.
 
Exclusion criteria:
- Subjects with mepolizumab during the Baseline (excluding the index date).
 - Subjects with an asthma-related biologic (e.g. omalizumab, reslizumab, benralizumab) during the 12 month Baseline period
 - Subjects with another asthma-related biologic (e.g. omalizumab, reslizumab, benralizumab)) during the 12 month Follow-up period)
 - Subjects with a diagnosis for chronic idiopathic urticaria (CIU), defined as a diagnosis code for urticaria (ICD-9-CM: 708 or ICD-10-CM: L50) in any position on a non-laboratory claim during the 12-month Baseline period.
 - Subjects with missing demographic information will be removed from the study.
 
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
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
2019-26-03
Actual study completion date
2019-26-03
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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