Last updated: 01/08/2025 06:20:10
Evaluating Asthma Control in participants on ‘Fluticasone propionate/Salmeterol Proactive regular dosing (PRD)’ with a history of uncontrolled asthma
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Retrospective, Observational, Multicenter Study Evaluating Asthma Control in patients on ‘Fluticasone propionate/Salmeterol PRD (Proactive Regular Dosing)’ with a history of uncontrolled asthma (MERIT)
Trial description: This is an observational study to evaluate real-life effectiveness in terms of asthma control in participants on proactive regular dosing (PRD) of Fluticasone propionate/Salmeterol (SERETIDE®) with a history of uncontrolled asthma with as needed (PRN) inhaled corticosteroids (ICS)/formoterol or ICS whenever short-acting beta 2 agonist (SABA) is taken.SERETIDE is a registered trademark of GlaxoSmithKline group of companies.
Primary purpose:
Other
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with Asthma control test (ACT) score greater than or equal to (>=)20 or showing improvement in ACT score >=3
Timeframe: Up to 16 months
Secondary outcomes:
Number of participants with adverse drug reactions
Timeframe: Up to 16 months
Number of participants with moderate to severe asthma exacerbation rate
Timeframe: Up to 16 months
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2023-31-05
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Ahmad Izuanuddin Ismail, Irfhan Ali Hyder Ali, Chee Kuan Wong, Andrea Yu-Lin Ban, Fatimah Mz Zahrah, Li Khen Lem, Zamzurina Abu Bakar, Arvindran Alaga, Azza Omar, Azlina Samsudin, Siew Li Lai, Alap Gandhi. A Retrospective Study Evaluating Asthma Control in Patients on Fluticasone Propionate/Salmeterol Proactive Regular Dosing with a History of Uncontrolled Asthma. Pulmonary therapy. 2024-Nov-09;
PMID: 39520649
DOI: 10.1007/s41030-024-00278-8
Medical condition
Asthma
Product
fluticasone propionate
Collaborators
NA
Study date(s)
January 2023 to May 2023
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18 Years - NA
Accepts healthy volunteers
No
- Inclusion Criteria:
- Physician diagnosed asthma participant
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion Criteria:
- Physician diagnosed asthma participant
- Participants on Fluticasone propionate and Salmeterol PRD, with a history of uncontrolled asthma (ACT less than [<]20) on ICS/Formoterol PRN or ICS whenever SABA is used.
- Participant who stepped up to SERETIDE within 01-Jan-2021 to 30-Nov-2021.
- Participant is male or female and aged >=18 years
- Availability of protocol defined retrospective participant records required for the assessment of study endpoints Exclusion criteria:
- Participant on ICS/Long-Acting beta 2- Agonist (LABA) other than Fluticasone propionate and Salmeterol
- Pregnant females
- History of chronic obstructive pulmonary disease (COPD)
- History of life-threatening asthma 12 months prior to enrollment
- Participants with suspected/known allergy to Fluticasone propionate or Salmeterol.
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
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
2023-31-05
Actual study completion date
2023-31-05
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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