Last updated: 11/28/2023 13:43:04

Real world data on asthma control levels in participants taking fluticasone propionate/salmeterol (FP/Sal) Diskus treatment

GSK study ID
217676
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: Real World Data on Asthma Control Levels of uncontrolled or partly controlled Asthma Patients Who were Prescribed regular FP/Sal Diskus treatment in Turkey
Trial description: This is a medical record review study aimed to provide up-to-date, country specific data on asthma management by assessing asthma control, number of exacerbations, and hospitalizations in adult participants who have a physician decision to initiate FP/Sal Diskus as the regular asthma treatment due to uncontrolled or partly controlled asthma.
Primary purpose:
Other
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Asthma control levels according to asthma control test (ACT) scores

Timeframe: Up to 3 months

Secondary outcomes:

Median number of exacerbations per participant

Timeframe: Up to 3 months

Number of participants experiencing at least one exacerbation

Timeframe: Up to 3 months

Number of participants with at least three exacerbations

Timeframe: Up to 3 months

Number of asthma related hospitalizations

Timeframe: Up to 3 months

Asthma control levels according to Global Initiative for Asthma's (GINA) level of asthma control definition

Timeframe: Up to 3 months

Number of particpants with demographics, clinical characteristics

Timeframe: Up to 3 months

Number of participants with comorbidities

Timeframe: Upto 3 months

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2023-12-06
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone propionate
Collaborators
Not applicable
Study date(s)
October 2022 to June 2023
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Participant must be greater than or equal to (>=) 18 years of age on index date.
  • Participants must have a documented physician diagnosed asthma.
  • Participation in a clinical/interventional study at any point during the study period.
  • Greater than or equal to (>=) 1 occurrence of a diagnosis code for the following diagnoses recorded at index date or at any follow up visit after index date: Chronic Obstructive Pulmonary Disease (COPD), asthma-COPD overlap syndrome (ACOS), an interstitial lung disease, cystic fibrosis, lung cancer, Eosinophilic granulomatosis with polyangiitis (EGPA), Allergic Bronchopulmonary Aspergillosis (ABPA).
Inclusion and exclusion criteria
Inclusion criteria:
  • Participant must be greater than or equal to (>=) 18 years of age on index date.
  • Participants must have a documented physician diagnosed asthma.
  • Participants, who are under any maintenance treatment for asthma, should be prescribed and commenced FP/Sal Diskus with a physician decision at index date.
  • Participants should be uncontrolled or partly controlled at index date.
  • Participants should have at least one more documented follow up visit at 6 months plus or minus (+-) 4 weeks after index date.
  • Eligible participant's records should include ACT scores and GINA asthma control criteria assessments.
Exclusion criteria:
  • Participation in a clinical/interventional study at any point during the study period.
  • Greater than or equal to (>=) 1 occurrence of a diagnosis code for the following diagnoses recorded at index date or at any follow up visit after index date: Chronic Obstructive Pulmonary Disease (COPD), asthma-COPD overlap syndrome (ACOS), an interstitial lung disease, cystic fibrosis, lung cancer, Eosinophilic granulomatosis with polyangiitis (EGPA), Allergic Bronchopulmonary Aspergillosis (ABPA).
  • Severe psychiatric illness or other disease that impairs cognitive ability and/or impacts the participant's routine treatment for asthma, and thus could compromise their participation in the study.
  • No current use of phenotypic therapies (biologics, aspirin desensitization, immunotherapy) and biologics for severe asthma at index date / and during the study period.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Study complete
Actual primary completion date
2023-12-06
Actual study completion date
2023-12-06

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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