Last updated: 09/14/2020 14:10:11

Impact of Nucala on ExacerbationsNucala

GSK study ID
209032
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: 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
Medical condition
Asthma
Product
mepolizumab
Collaborators
Optum
Study date(s)
December 2018 to March 2019
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
  • 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

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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