Last updated: 06/11/2025 13:00:53

Assessment of symptom control in asthma participants

GSK study ID
209689
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: Symptom control in asthma patients using ICS/LABAs (FF/VI, B/F)
Trial description: Asthma is chronic respiratory disease characterized by inflammation and narrowing of airways, resulting in episodic symptoms of coughing, wheezing, chest tightness, and shortness of breath. Currently there are several fixed-dose Inhaled corticosteroids (ICS)/Long-acting beta2 agonist (LABA) combinations with different dosing regimens available to treat asthma. Previous studies have shown improved adherence and lower rates of treatment discontinuation with Fluticasone furoate/vilanterol (FF/VI) (100/25 micrograms [mcg]) compared to budesonide/formoterol (B/F). This study will be conducted to compare once-daily FF/VI 100/25 mcg versus twice daily B/F 160/4.5 mcg on asthma symptom control outcomes, including rescue medication (short-acting beta2 agonists [SABA]) use and asthma-related exacerbations, in adult asthma participants using a large, multi-payer United States (US) claims database. Data will be collected using the IQVIA database which contains participant's fully adjudicated claims data with average length of health plan enrollment approximately 3 or more years. The participant count will be based on data from 01-Jan-2013 to 30-Jun-2018.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Mean number of SABA canisters

Timeframe: Up to 7 years

Secondary outcomes:

Time-to-first overall asthma related exacerbations

Timeframe: Up to 7 years

Time-to-first severe asthma related exacerbations

Timeframe: Up to 7 years

Rate of overall asthma-related exacerbations

Timeframe: Up to 7 years

Rate of severe asthma-related exacerbations

Timeframe: Up to 7 years

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2020-17-06
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Carlyne M. Averell, Francois Laliberte, Guillaume Germain, Mei Sheng Duh, Robson Lima, Malena Mahendran, David J. Slade. Symptom control in patients with asthma using inhaled corticosteroids/long-acting ß2-agonists (fluticasone furoate/vilanterol or budesonide/formoterol) in the US: a retrospective matched cohort study. J Asthma. 2021;:1-14 DOI : 10.1080/02770903.2021.1963767 PMID : 34375568
Medical condition
Asthma
Product
Not applicable
Collaborators
Analysis Group
Study date(s)
November 2019 to June 2020
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Participants with greater than or equal to 1 pharmacy claim for FF/VI 100/25 mcg or B/F 160/4.5 mcg during the participant identification period (January 1, 2014-March 31, 2018). The date of the first claim will be defined as the index date.
  • Participants with greater than or equal to 12 months of continuous enrollment with medical and pharmacy coverage prior to the index date (i.e., Baseline period).
  • Participants with greater than or equal to 1 pharmacy claim for any fixed-dose ICS/LABA during the 12-month Baseline period; participants using the index ICS/LABA during Baseline will also be excluded.
  • Participants with greater than or equal to 1 pharmacy claim for multiple fixed-dose ICS/LABA on the index date.
Inclusion and exclusion criteria
Inclusion criteria:
  • Participants with greater than or equal to 1 pharmacy claim for FF/VI 100/25 mcg or B/F 160/4.5 mcg during the participant identification period (January 1, 2014-March 31, 2018). The date of the first claim will be defined as the index date.
  • Participants with greater than or equal to 12 months of continuous enrollment with medical and pharmacy coverage prior to the index date (i.e., Baseline period).
  • Participants with greater than or equal to 3 months of continuous enrollment with medical and pharmacy coverage post-index date (i.e., follow-up period).
  • Participants with greater than or equal to 1 medical claim with a primary or secondary diagnosis for asthma during the Baseline period or on the index date.
  • Participants with greater than or equal to 18 years of age at index date.
Exclusion criteria:
  • Participants with greater than or equal to 1 pharmacy claim for any fixed-dose ICS/LABA during the 12-month Baseline period; participants using the index ICS/LABA during Baseline will also be excluded.
  • Participants with greater than or equal to 1 pharmacy claim for multiple fixed-dose ICS/LABA on the index date.
  • Participants with greater than or equal to 1 medical claim with a diagnosis for chronic obstructive pulmonary disease during the Baseline or follow-up period.
  • Participants with greater than or equal to 1 medical claim with a diagnosis (primary or secondary) for the following lung diseases: Acute respiratory failure diagnosis in the baseline or on the index date; cystic fibrosis diagnosis in the Baseline or follow-up period.

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
2020-17-06
Actual study completion date
2020-17-06

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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