Last updated: 06/11/2025 14:00:42

Impact of ICS/LABA adherence on asthma outcomes

GSK study ID
209691
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: Evaluation of the Association between Adherence to ICS/LABAs and Asthma Outcomes in the U.S
Trial description: Asthma is managed with two types of treatment: long-term controller medications that help to reduce inflammation and prevent asthma symptoms, and rescue medications such as short-acting beta 2-agonists (SABAs) and oral corticosteroids (OCSs) that quickly relieve symptoms. For participants who are unable to control their asthma symptoms with inhaler inhaled corticosteroids (ICS) alone, guidelines recommend the addition of long-acting beta-2 agonists (LABAs) to a participant's treatment regimen. This study will evaluate the relationship between medication adherence to single ICS/LABAs (measured via proportion of days covered proportion of days covered [PDC] which represents the proportion of time over the course of a participant's treatment that he/she theoretically was in possession of the medication) and asthma outcomes, including asthma-related exacerbations, SABA use, OCS use, asthma-related healthcare resource utilization (HRU) and healthcare costs, among adult patients with asthma. This is retrospective longitudinal design which will be implemented using medical and pharmacy claims data and enrollment information from 01-January-2014 to 30-June-2019.
Primary purpose:
Treatment
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Percentage of participants with greater than or equal to 1 asthma-related overall exacerbation

Timeframe: Up to 12 months

Rate of asthma-related overall exacerbations PPPQ

Timeframe: Up to 12 months

Secondary outcomes:

Percentage of participants with greater than or equal to 1 asthma-related severe exacerbation

Timeframe: Up to 12 months

Rate of asthma-related severe exacerbations PPPQ

Timeframe: Up to 12 months

Mean number of SABA canisters

Timeframe: Up to 12 months

Percentage of participants with greater than or equal to 1 dispensing of SABA

Timeframe: Up to 12 months

Mean number of oral corticosteroids (OCS) dispensings PPPQ

Timeframe: Up to 12 months

Percentage of participants with greater than or equal to 1 OCS dispensing

Timeframe: Up to 12 months

Asthma-related healthcare resource utilization (HRU) PPPQ

Timeframe: Up to 12 months

Asthma-related Healthcare Costs

Timeframe: Up to 12 months

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2020-15-09
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Carlyne M. Averell, Francois Laliberte, Guillaume German, Mei Sheng Duh, Matthew D. Rousculp, Sean MacKnight, David J. Slade. Impact of adherence to treatment with inhaled corticosteroids/long-acting β-agonists on asthma outcomes in the US.Ther Adv Respir Dis.2022;16:1-17 DOI: https://doi.org/10.1177/17534666221116997
Medical condition
Asthma
Product
Not applicable
Collaborators
Not applicable
Study date(s)
February 2020 to September 2020
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Participants with at least one pharmacy claim for fixed-dose ICS/LABA during the study period (01-January-2014 to 30-June-2019; the first ICS/LABA dispensing will be referred to as the index date.
  • Participants with at least 12 months of continuous eligibility prior to the index date (Baseline period).
  • Participants with at least one diagnosis of chronic obstructive pulmonary disorder during the Baseline or follow-up period.
  • Participants with at least one pharmacy claim for a Long-Acting Muscarinic Antagonists (LAMAs) controller medication during the Baseline period or on the index date (which in combination with an ICS/LABA constitute a triple therapy).
Inclusion and exclusion criteria
Inclusion criteria:
  • Participants with at least one pharmacy claim for fixed-dose ICS/LABA during the study period (01-January-2014 to 30-June-2019; the first ICS/LABA dispensing will be referred to as the index date.
  • Participants with at least 12 months of continuous eligibility prior to the index date (Baseline period).
  • Participants with at least 6 months of follow-up post index date.
  • Participants with at least one independent medical claims with a primary or secondary diagnosis for asthma (International Classification of Diseases, 9th Revision, Clinical Modification [ICD-9-CM], ICD-10-CM during the Baseline period.
  • Participants with at least 18 years of age as of the index date.
Exclusion criteria:
  • Participants with at least one diagnosis of chronic obstructive pulmonary disorder during the Baseline or follow-up period.
  • Participants with at least one pharmacy claim for a Long-Acting Muscarinic Antagonists (LAMAs) controller medication during the Baseline period or on the index date (which in combination with an ICS/LABA constitute a triple therapy).
  • Participants with at least one medical claim for the following lung diseases during the Baseline period or on the index date: Acute respiratory failure, Cystic fibrosis.
  • Participants with at least one diagnosis of lung cancer at any time during the study period.
  • Participants with at least one diagnosis of bronchiectasis at any time during the study period.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Study report synopsis
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
2020-15-09
Actual study completion date
2020-15-09

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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