Last updated: 07/14/2020 19:00:05
Administration and Usage Patterns for Albuterol and Asthma Controllers in Patients Using Inhaler Monitoring Technology
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Administration and Usage Patterns for Albuterol and Asthma Controllers in Patients Using Inhaler Monitoring Technology
Trial description: Subject adherence to prescribed therapies is of key importance in asthma treatment. Remote electronic monitoring devices (EMDs) provides an insight of actual-use of prescribed therapies in real-time. This longitudinal, observational study aims to assess inhaled medication usage patterns and symptom control with the use of EMDs in adult subjects with asthma as part of a novel data collection methodology combining prospective and retrospective research strategies. Subjects with asthma will be included using claims data records from the Optum Research Database (ORD) for the period of 01-Dec-2015 to 30-Nov-2016. The study will be conducted in 2 phases; in the first phase, approximately 530 subjects with asthma reporting concomitant use of a rescue metered dose inhaler (MDI) and Advair DISKUS® will be recruited and in the second phase, approximately 265 subjects with asthma reporting concomitant use of a rescue MDI and Breo ELLIPTA® will be recruited. Phase 2 of the study will be initiated after an EMD has received clearance for over the counter (OTC) use with ELLIPTA inhalers. Subjects in either group will be asked to complete a Baseline mail survey and a follow up web-based survey at 3 and 6 months. Subjects in each group will also be invited to use EMDs, which attach to inhaler rescue and controller medications, on a daily basis for a concurrent six month period. This is an exploratory study to examine symptoms of asthma and medication-taking behavior. DISKUS and ELLIPTA are registered trademarks of GlaxoSmithKline group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Evaluation of patterns of inhaled controller use
Timeframe: Up to 6 months
Secondary outcomes:
Evaluation of patterns of concurrent rescue MDI use
Timeframe: Up to 6 months
Evaluation of the relationship between inhaled controller and concurrent rescue MDI use
Timeframe: Up to 6 months
Interventions:
Device: Electronic Monitoring Device
Other: Baseline survey
Device: Breo ELLIPTA
Device: Metered dose inhaler
Device: Advair DISKUS
Other: Web based survey
Enrollment:
0
Observational study model:
Cohort
Primary completion date:
2018-10-04
Time perspective:
Prospective
Clinical publications:
Richard H. Stanford, Carlyne M. Averell, Phaedra T. Johnson, Erin K. Buysman, Maureen H. Carlyle. Adherence and Usage Patterns of Inhaled Corticosteroids-Long-Acting Beta-Agonists by Using Inhaler-Monitoring Technology. Allergy Asthma Proc. 2020;41(4):256-264
DOI: 10.2500/aap.2020.41.200037
PubMed Id: 32605696
Medical condition
Asthma
Product
fluticasone furoate, fluticasone furoate/vilanterol, fluticasone propionate, fluticasone propionate/salmeterol, salmeterol, vilanterol
Collaborators
Not applicable
Study date(s)
January 2017 to April 2018
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Not applicable
- Identification criteria for Phase 1:
- Age 18 or older at the time of identification.
- Not applicable.
Inclusion and exclusion criteria
Inclusion criteria:
- Identification criteria for Phase 1:
- Age 18 or older at the time of identification.
- Continuous and current enrollment in the health plans affiliated with Optum during the 12 month identification period.
- Have more than or equal to 1 prescription (Rx) claims for a rescue MDI that can be utilized with a Propeller Health EMD [generic albuterol Hydrofluoroalkanes (HFA), ProAir HFA, Proventil HFA, Ventolin HFA, Xopenex HFA] during the most recent 6 months of the claims identification period.
- Have more than or equal to 1 Rx claims for Advair DISKUS during the most recent 6 months of the claims identification period.
- No evidence of chronic obstructive pulmonary disease (COPD) during the 12 month claims identification period evidence will be defined as more than or equal to 1 diagnosis claims for COPD. Diagnosis codes can be in any position on the medical claim. Both International Classification of diseases-9- clinical modification (ICD-9-CM) (491.xx, 492.xx, 493.2x, 496.xx) and ICD-10-CM codes will be used; Codes J40-J44 will be used to identify COPD which is commensurate with current Center for disease control and prevention (CDC) measurement of COPDxx. Inclusion criteria for Phase 1:
- Self-report a diagnosis of asthma on the Baseline survey.
- Confirmed use of Advair DISKUS on the Baseline survey.
- Confirmed use of a rescue MDI [albuterol (HFA), ProAir HFA, Proventil HFA, Ventolin HFA, Xopenex HFA] on the Baseline survey.
- Have ability to read, write, and comprehend information in English
- Be willing and able to provide informed consent.
- Continuous enrollment in the health plans affiliated with Optum during the 12 month pre-index and 6 month post index period. Identification criteria for Phase 2:
- Age 18 or older at the time of identification.
- Continuous and current enrollment in the health plans affiliated with Optum during the 12 month identification period.
- Have more than or equal to 1 Rx claims for a rescue MDI that can be utilized with a Propeller Health EMD (generic albuterol HFA, ProAir HFA, Proventil HFA, Ventolin HFA, Xopenex HFA) during the most recent 6 months of the claims identification period.
- Have more than or equal to 1 Rx claims for Breo ELLIPTA during the most recent 6 months of the claims identification period.
- No evidence of COPD during the 12 month claims identification period; evidence will be defined as more than or equal to 1 diagnosis claims for COPD. Diagnosis codes can be in any position on the medical claim. Both International ICD-9-CM (491.xx, 492.xx, 493.2x, 496.xx) and ICD-10-CM codes will be used. Inclusion criteria for Phase 2:
- Self-report a diagnosis of asthma on the Baseline survey.
- Confirmed use of Breo Ellipta on the Baseline survey.
- Confirmed use of a rescue MDI (albuterol HFA, ProAir HFA, Proventil HFA, Ventolin HFA, Xopenex HFA) on the Baseline survey.
- Have ability to read, write, and comprehend information in English.
- Be willing and able to provide informed consent.
- Continuous enrollment in the health plans affiliated with Optum during the 12 month pre-index and 6 month post index period.
Exclusion criteria:
- Not applicable.
Trial location(s)
No location data available.
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
Finalized
Actual primary completion date
2018-10-04
Actual study completion date
2018-10-04
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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