Last updated: 04/20/2023 14:20:20
SABA safety meta-analysis
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Systematic literature review (SLR) and meta-analysis (MA) on the safety of short-acting beta agonist (SABA), with a focus on salbutamol, in adults and adolescents with asthma
Trial description: This study will aim to understand the evidence around the safety and tolerability of SABA alone and in combination with inhaled corticosteroids (ICS) for management of adults and adolescents (aged 12 years and older) with asthma.
Primary purpose:
Other
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Percentage of participants with all-cause mortality
Timeframe: Up to 54 weeks
Percentage of participants with treatment-related mortality
Timeframe: Up to 54 weeks
Secondary outcomes:
Percentage of participants with treatment-related adverse events and serious adverse events (SAEs)
Timeframe: Up to 54 weeks
Percentage of participants with treatment-discontinuations or withdrawals due to adverse events
Timeframe: Up to 54 weeks
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2022-22-04
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Thitiwat Sriprasart, Grant Waterer, Gabriel Garcia, Adalberto Rubin, Marco Antonio Loustaunau Andrade, Agnieszka Roguska, Abhay Phansalkar, Sourabh Fulmali, Amber Martin, Lalith Mittal, Bhumika Aggarwal, Gur Levy. Safety of SABA monotherapy in asthma management: a systematic review and meta-analysis. Adv Ther. 2022;
DOI: 10.1007/s12325-022-02356-2
PMID: 36348141
Medical condition
Asthma
Product
salbutamol/norflurane
Collaborators
Not applicable
Study date(s)
April 2022 to April 2022
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- Adolescent and adult participants (12 years and older) diagnosed with asthma.
- Monotherapy with inhaled SABA with a minimum treatment duration of greater than or equal to (>=)4 weeks: Salbutamol; Levosalbutamol; Albuterol; Levalbuterol; Pirbuterol will be included.
- Participants with asthma aged below 12 years; Studies of participants without asthma.
- Intervention not listed under the inclusion criteria; Studies with a treatment duration of less than (<)4 weeks; Studies that evaluated fenoterol; Studies on nebulized or oral treatments; Dose-finding studies.
Inclusion and exclusion criteria
Inclusion criteria:
- Adolescent and adult participants (12 years and older) diagnosed with asthma.
- Monotherapy with inhaled SABA with a minimum treatment duration of greater than or equal to (>=)4 weeks: Salbutamol; Levosalbutamol; Albuterol; Levalbuterol; Pirbuterol will be included.
- None required for single-arm studies; Combination of SABA with other inhaled asthma medications will be included.
- Studies published from 1-Jan-1996 to 9-Dec-2021.
- Studies published in English language will be included.
Exclusion criteria:
- Participants with asthma aged below 12 years; Studies of participants without asthma.
- Intervention not listed under the inclusion criteria; Studies with a treatment duration of less than (<)4 weeks; Studies that evaluated fenoterol; Studies on nebulized or oral treatments; Dose-finding studies.
- Comparator not listed under the inclusion criteria.
- Studies published before 1996 or after 2021 will be excluded.
- Studies published in languages other than English.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
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
2022-22-04
Actual study completion date
2022-22-04
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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