Last updated: 05/20/2020 08:30:09
Asthma Exacerbations and Costs- Xolair 12 Months Pre- & Post- Administration
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Asthma Exacerbations and Costs- Xolair 12 Months Pre- & Post- Administration
Trial description: Omalizumab is a recombinant deoxyribonucleic acid (DNA)-derived humanized immunoglobulin G1 kappa (IgG1 κ) monoclonal antibody administered by subcutaneous injection by a health care professional. Asthma is a common chronic respiratory disorder that effects millions of children and adults in the United States (U.S.). Omalizumab (XOLAIR®) has been shown to reduce the frequency of asthma exacerbations in subjects with severe asthma. This is a retrospective cohort study comparing rates of acute asthma exacerbations and costs associated with those exacerbations among subjects receiving omalizumab. Subjects with medical or pharmacy claim between November 1, 2015 and September 30, 2016 Healthcare Common Procedure Coding System (HCPCS) or National Drug Code (NDC) code indicating administration of omalizumab were a part of MarketScan Commercial database. This study will try to analyze performance of omalizumab in the market which will include effect on rate of asthma exacerbation and the associated costs. The data for this study will be derived from Truven Health’s MarketScan Research Databases. XOLAIR is the registered trademark of Novartis Europharm Limited.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Total number of acute asthma exacerbations per subject
Timeframe: Approximately 3 years
Percentage of subjects with asthma exacerbations
Timeframe: Approximately 3 years
Percentage of subjects with asthma exacerbation resulting in hospitalization
Timeframe: Approximately 3 years
Total number of any exacerbation
Timeframe: Approximately 3 years
Total number of asthma exacerbations requiring hospitalization
Timeframe: Approximately 3 years
Rate of exacerbation
Timeframe: Approximately up to 3 years
Secondary outcomes:
Total cost related to asthma exacerbation
Timeframe: Approximately up to 3 years
Number of claims with asthma exacerbation related costs
Timeframe: Approximately up to 3 years
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2018-07-12
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Asthma
Product
mepolizumab, omalizumab
Collaborators
Truven Health Analytics
Study date(s)
July 2018 to December 2018
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
None
- Subjects with medical or pharmacy claim between November 1, 2015 and September 30, 2016 with a HCPCS or NDC code indicating administration of omalizumab. The date of first omalizumab administration will be the index date.
- Subjects with 12-months of continuous enrollment with medical and pharmacy benefits in the year prior to the index date (Baseline period).
- Subjects with evidence of omalizumab use during the 12-month Baseline period.
- Subjects with evidence of mepolizumab use during the 12-month Baseline or 12-month follow-up periods.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects with medical or pharmacy claim between November 1, 2015 and September 30, 2016 with a HCPCS or NDC code indicating administration of omalizumab. The date of first omalizumab administration will be the index date.
- Subjects with 12-months of continuous enrollment with medical and pharmacy benefits in the year prior to the index date (Baseline period).
- Subjects with 12-months of continuous enrollment with medical and pharmacy in the year including and following the index date (follow-up period).
- Subjects with a diagnosis of asthma during the 12-month Baseline period.
- Subjects at least 12 years of age as of index.
- Subjects with a minimum of 2 doses of omalizumab in the first 180 days of the 12-month follow-up period.
Exclusion criteria:
- Subjects with evidence of omalizumab use during the 12-month Baseline period.
- Subjects with evidence of mepolizumab use during the 12-month Baseline or 12-month follow-up periods.
- Subjects with evidence of reslizumab use during the 12-month Baseline or 12-month follow-up periods.
- Subjects with evidence of benralizumab use during the 12-month Baseline or 12-month follow-up periods.
- Subjects with evidence of dupilumab use during the 12-month Baseline or 12-month follow-up periods.
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
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
2018-07-12
Actual study completion date
2018-07-12
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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