Last updated: 04/07/2025 09:30:38
Treatable Traits in Asthma participants
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Meta-Analysis of Proactive Regular Dosing versus Maintenance and Reliever Therapy by Treatable Traits in Adult Patients with Asthma
Trial description: The purpose of this analysis is to identify and measure the extent to which Treatable traits (TTs) may modify the treatment effects of asthma therapies on efficacy outcomes in mild and moderate-severe asthma.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Mean change from Baseline in pre or unspecified Forced expiratory volume in 1 second (FEV1)
Timeframe: Baseline and Up to 6 months
Rate of severe exacerbations
Timeframe: Up to 6 months
Time to first severe exacerbation
Timeframe: Up to 6 months
Mean change from Baseline in inhalations of reliever medication per day
Timeframe: Baseline and Up to 6 months
Mean proportion of expected doses actually used during the study.
Timeframe: Up to 6 months
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2023-04-04
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Arzu Yorgancıoğlu, Alvaro A Cruz, Gabriel Garcia, Kim L Lavoie, Nicolas Roche, Manish Verma, Anurita Majumdar, Swarnendu Chatterjee. A network meta-analysis of the association between patient traits and response to regular dosing with ICS plus short-acting β2-agonist reliever or ICS/formoterol reliever only in mild asthma. Respiratory medicine. 2024-May; 226:107610
DOI: 10.1016/j.rmed.2024.107610
PMID: 38561078
Medical condition
Asthma
Product
fluticasone propionate/salmeterol
Collaborators
Not applicable
Study date(s)
March 2023 to April 2023
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Population:
- Participants with a diagnosis of asthma only
- Population:
- Studies with no asthmatic participants (overall population or subgroup)
Inclusion and exclusion criteria
Inclusion criteria:
- Population:
- Participants with a diagnosis of asthma only
- Studies including adult participants (greater than or equal to ([>=] 18 years old)
- Interventions and Comparators:
- Studies including at least one arm of Proactive regular dosing (PRD) and/or Single maintenance and reliever therapy ([S]MART) regimen
- Outcomes:
- Studies aiming to assess the efficacy of PRD or (S)MART dosing regimens through >= 1 clinical outcome of interest
- Study design:
- Comparative Randomized control trials (RCTs) of at least 12 weeks
- Study type:
- Original research only
- Language:
- English
- Time restriction:
- 01 January 1998 to 03 August 2022
- Geographical scope:
- No restriction
Exclusion criteria:
- Population:
- Studies with no asthmatic participants (overall population or subgroup)
- Studies including only participants with allergic asthma, seasonal asthma, exercise induced asthma, aspirin induced asthma
- Pediatric population only
- Intervention and comparators:
- Studies with no PRD or (S)MART therapies
- Anti-inflammatory reliever (AIR) therapy alone (example [e.g.,] as needed low dose Inhaled corticosteroid (ICS)-formoterol or as needed Short acting beta agonist [SABA]) without a controller medication
- Outcomes:
- Studies with no outcomes of interest (outcome not measured)
- Study design:
- RCTs of less than 12 weeks
- Non-randomized trials
- Clinical trials without published results
- Study protocols
- Observational studies
- Reviews
- Descriptive studies (case report, case series)
- Expert opinions, editorials, letters to editors
- Non-human studies
- Study type:
- Results only available in abstract/poster format
- Language:
- Non-English publications
- Time restriction:
- Articles published before 1998
- Geographical scope:
- Not applicable (N/A)
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Study report synopsis
Available language(s): English
Protocol
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
2023-04-04
Actual study completion date
2023-04-04
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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