A Phase 2/3 interventional study of fluticasone-vilanterol and Standard Preparation in Asthma, sponsored by Royal College of Surgeons in Ireland - Medical University of Bahrain. Completed at 1 site in Bahrain. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-03-31.
Sponsored by Royal College of Surgeons in Ireland - Medical University of Bahrain · Phase 2/3, Interventional, and Treatment
Investigators will test the superiority of Superiority Trial of Fluticasone-Vilanterol as needed in mild asthma compared to standard of care
single centre randomised control trial with the aim of comparing the superiority of effectiveness and safety of fluticasone-vilanterol versus usual care. In this study there is random allocation of participants to usual care (Any ICS or SABA combination) or fluticasone-vilanterol daily single dose for the relief of symptoms.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's enrollment of 18 is below the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →Royal College of Surgeons in Ireland - Medical University of Bahrain is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short acting beta agonist or inhaled corticosteroids
Drug: Standard Preparation
LABA-ICS A combination of Long acting beta agonist and inhaled corticosteroid
Drug: fluticasone-vilanterol
LABA-ICS combination Inhaled Long acting Beta agonist and inhaled corticosteroid
inhaled SABA or Inhaled corticosteroid
Also known as: standard of care
Number of asthma exacerbations
measured by asking the participants about Hospital admission with asthma/ Visit to ED with Asthma and receiving treatment with nebulizer and/ or any corticosteroids (IV, IM, PO or neb)/ Home use of nebulizer and/or corticosteroids (IV, IM, oral or nebulized). treatment with nebulizer and/ or any corticosteroids (IV, IM, PO or neb)/ Home use of nebulizer and/or corticosteroids (IV, IM, oral or nebulized)
Time frame: 32 weeks/8 months
Change in Asthma Control Score
measured by the 7 item asthma control questionnaire. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control.
Time frame: baseline, 8 months
Change in Asthma Quality of life score
Measured using a 32 item questionnaire Scores range 1-7, with higher scores indicating better quality of life. a minimal important within-subject change in an AQLQ subscale or overall scale score is 0.5, with changes of 1.0 considered moderate and changes of 2.0 considered large
Time frame: baseline, 8 months
Plan to share: No — Study documents (paper and electronic) will be retained in a secure (kept locked when not in use) location during and after the trial has finished. All essential documents including source documents will be retained for a period of 3 years after study completion (last patient, last visit). A label stating the date after which the documents can be destroyed will be placed on the inside front cover of the case notes of trial participants.Monitoring, audits, and REC review will be permitted and provide direct access to source data and documents. The Lead PI and the researcher assigned by her will have access to the stored data. Only the CRCs and Lead PI working on this study will be eligible to obtain the data from the participants during data collection visits.
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Royal College of Surgeons in Ireland - Medical University of Bahrain