Last updated: 05/05/2023 12:30:16
A study to assess changes in dose or frequency of asthma maintenance therapy
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Patient-initiated changes in the dose and frequency of their asthma maintenance therapy
Trial description: This study aims to assess the frequency of participant-initiated changes in dose or frequency in asthma maintenance therapy among participants who participated in the Extended Salford Lung Study (Ex-SLS). The index date will be defined as the date on which each participant consented to inclusion in the Ex-SLS study.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of self-reported changes to dose or frequency of asthma maintenance therapy in overall participants
Timeframe: Up to 6 months prior to index date
Number of self-reported changes to dose or frequency of asthma maintenance therapy in participants using Inhaled corticosteroids-Long-acting beta-agonist (ICS-LABA)
Timeframe: Up to 6 months prior to index date
Secondary outcomes:
Summary of socio-demographic, clinical and asthma-related characteristics by frequency/dose of self-reported moderate asthma exacerbations in overall participants
Timeframe: Up to 6 months prior to index date
Summary of socio-demographic, clinical and asthma-related characteristics by frequency/dose changes of self-reported moderate asthma exacerbations in participants using ICS-LABA
Timeframe: Up to 6 months prior to index date
Number of participants with asthma control
Timeframe: Up to 6 months prior to index date
Asthma Control Questionnaire- 6-item (ACQ-6) score at indicated time point
Timeframe: Up to 6 months prior to index date
Asthma Control Test (ACT) score at indicated time point
Timeframe: Up to 6 months prior to index date
All-cause and asthma-related healthcare resource utilization (HCRU) (primary and secondary care) in participants using ICS-LABA
Timeframe: Up to 6 months prior to index date
Number of moderate and severe asthma exacerbations in participants using ICS-LABA
Timeframe: Up to 6 months prior to index date
Number of prescriptions of short-acting beta agonist (SABA) in participants using ICS-LABA
Timeframe: Up to 6 months prior to index date
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2022-05-05
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Asthma
Product
fluticasone furoate/vilanterol/umeclidinium bromide
Collaborators
Not applicable
Study date(s)
May 2021 to May 2022
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Participants must have questionnaire data and valid primary care Electronic medical record (EMR) data.
- Participants endorsed either response option “Yes” or “No” to item M1 (question pertaining to whether the participant had implemented a self-initiated change in dose or frequency of their maintenance therapy in the prior six months) in the Ex-SLS questionnaire (that is [i.e.] not Don’t know/No answer”)
- None
Inclusion and exclusion criteria
Inclusion criteria:
- Participants must have questionnaire data and valid primary care Electronic medical record (EMR) data.
- Participants endorsed either response option “Yes” or “No” to item M1 (question pertaining to whether the participant had implemented a self-initiated change in dose or frequency of their maintenance therapy in the prior six months) in the Ex-SLS questionnaire (that is [i.e.] not Don’t know/No answer”)
Exclusion criteria:
- None
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Protocol
Available language(s): English
Statistical analysis plan
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
Study complete
Actual primary completion date
2022-05-05
Actual study completion date
2022-05-05
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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