Last updated: 06/01/2020 15:10:12

Treatment Adherence in Asthma Patients Using Inhaled Corticosteroids (ICS)/Long-Acting Beta Agonists (LABAs)

GSK study ID
208604
See study documents
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: Treatment Adherence in Asthma Patients Using Inhaled Corticosteroids (ICS)/Long-Acting Beta Agonists (LABAs)
Trial description: The study will examine and compare treatment adherence, persistence, and the asthma medication ratio (AMR) in adult subjects with asthma initiating treatment with fluticasone furoate/vilanterol (FF/VI, Breo Ellipta®) and budesonide/formoterol (B/F, Symbicort®) (or fluticasone propionate/salmeterol [FP/SAL, Advair Diskus®]). This is a retrospective cohort study, which will use medical and pharmacy claims data and enrollment information from the QuintilesIMS Real World Data (RWD) Adjudicated Claims database for the study period January 1, 2013 to September 30, 2016. The study will include asthma subjects age 18 years and older who initiated treatment with FF/VI or B/F (or FP/SAL) between January 1, 2014 and September 30, 2016. The date of the first prescription filled will be termed the index date. All subjects selected will be required to be continuously enrolled for at least 12 months prior to the index date and for a minimum of 3 months following the index date. Breo Ellipta and Advair Diskus are registered trademarks of GlaxoSmithKline group of companies. Symbicort is a registered trademark of AstraZeneca group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Mean Proportion of Days Covered (PDC)

Timeframe: Up to 12 months

Secondary outcomes:

Proportion of subjects with PDC >= 0.5 and PDC >= 0.8

Timeframe: Up to 12 months

Time to index medication discontinuation

Timeframe: Up to 12 months

Mean Asthma Medication Ratio (AMR)

Timeframe: Up to 12 months

Proportion of subjects with AMR >= 0.5

Timeframe: Up to 12 months

Mean Medication Possession Ratio (MPR)

Timeframe: Up to 12 months

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2018-20-07
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Carlyne M. Averell, Richard H. Stanford, François Laliberté, Jennifer W. Wu, Guillaume Germain, Mei Sheng Duh.Medication adherence in patients with asthma using once-daily versus twice-daily ICS/LABAs.J Asthma. 2019;:1-10 DOI: 10.1080/02770903.2019.1663429 PMID: 31607180
Medical condition
Asthma
Product
budesonide, budesonide/formoterol, fluticasone furoate, fluticasone furoate/vilanterol, fluticasone propionate, fluticasone propionate/salmeterol, formoterol, salmeterol, vilanterol
Collaborators
Not applicable
Study date(s)
December 2017 to July 2018
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Not applicable
  • At least one prescription fill for FF/VI (100/25 micrograms), B/F (160/4.5 micrograms) or FP/SAL (250/50 micrograms) during the subject identification period (1 January 2014 - 30 June 2016). The date of the first prescription fill will be termed as the index date.
  • At least 12 months of continuous eligibility before the index date (period termed as Baseline).
  • At least one diagnosis of chronic obstructive pulmonary disease (ICD-9-CM: 491.x, 492.x, 496.x; ICD-10-CM: J41-J44) during the Baseline or follow-up period.
  • At least one diagnosis of cystic fibrosis (ICD-9-CM: 277.0, ICD-10-CM: E84.0-E84.9) during the Baseline or follow-up period.
Inclusion and exclusion criteria
Inclusion criteria:
  • At least one prescription fill for FF/VI (100/25 micrograms), B/F (160/4.5 micrograms) or FP/SAL (250/50 micrograms) during the subject identification period (1 January 2014
  • 30 June 2016). The date of the first prescription fill will be termed as the index date.
  • At least 12 months of continuous eligibility before the index date (period termed as Baseline).
  • At least 3 months of continuous eligibility after the index date (period termed as follow-up).
  • At least one diagnosis of asthma (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM]: 493.xx; ICD-10-CM: J45.3, J45.4, J45.5, J45.9) during the Baseline period or on the index date.
  • At least 18 years of age as of the index date.
Exclusion criteria:
  • At least one diagnosis of chronic obstructive pulmonary disease (ICD-9-CM: 491.x, 492.x, 496.x; ICD-10-CM: J41-J44) during the Baseline or follow-up period.
  • At least one diagnosis of cystic fibrosis (ICD-9-CM: 277.0, ICD-10-CM: E84.0-E84.9) during the Baseline or follow-up period.
  • At least one diagnosis of acute respiratory failure (ICD-9-CM: 518.81, ICD-1 0 CM:J96.0, J96.2) during the Baseline period.
  • At least one prescription fill for an ICS/LABA medication (fixed dose) in the 12-month Baseline period. Subjects using the index ICS/LABA during Baseline will also be excluded.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Clinical study report
Available language(s): English
Download document(s)
Protocol
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

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
2018-20-07
Actual study completion date
2018-20-07

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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