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Clinical trial

A Pilot Randomised Controlled Superiority Trial of Fluticasone-Vilanterol Once Daily Dose for the Treatment of Mild Asthma in Adults

ID
Name
RCSIBahrain
Description
Investigators will test the superiority of Superiority Trial of Fluticasone-Vilanterol as needed in mild asthma compared to standard of care
Trial arms
Trial start
2021-12-22
Estimated PCD
2023-01-18
Trial end
2023-01-18
Status
Completed
Phase
Early phase I
Treatment
fluticasone-vilanterol
LABA-ICS combination Inhaled Long acting Beta agonist and inhaled corticosteroid
Arms:
fluticasone-vilanterol
Standard Preparation
inhaled SABA or Inhaled corticosteroid
Arms:
standard of care
Other names:
standard of care
Size
18
Primary endpoint
Number of asthma exacerbations
32 weeks/8 months
Change in Asthma Control Score
baseline, 8 months
Eligibility criteria
Inclusion Criteria: * Adults between the ages of 18 and 75 years old with a diagnosis of mild asthma attending the participating primary health care centres in Bahrain, being managed with usual care (SABA or ICS and SABA combination) and no other medications Exclusion Criteria: * Health centre medical record or self-reported use of LABA, leukotriene receptor agonist, theophylline, anticholinergic agent, oral corticosteroids for regular maintenance therapy in 3 months before entry to the trial. \[NB. nasal corticosteroid is permitted
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Investigators will compare the superiority of effectiveness and safety of fluticasone-vilanterol versus usual care. In this study, there is a random allocation of participants to usual care (Any ICS or SABA combination) or fluticasone-vilanterol single daily use for the relief of symptoms.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 18, 'type': 'ACTUAL'}}
Updated at
2023-03-31

1 organization

2 products

1 indication

Organization
Royal College of Surgeons in Ireland - Medical University of Bahrain
Product
fluticasone-vilanterol
Indication
Asthma
Product
Standard Preparation