Fluticasone-Vilanterol Once Daily Dose for the Treatment of Mild Asthma in Adults

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: Standard Preparation; Drug: fluticasone-vilanterol

• Registration Number: NCT04265105
• Lead Sponsor: Royal College of Surgeons in Ireland - Medical University of Bahrain

Brief Summary

Investigators will test the superiority of Superiority Trial of Fluticasone-Vilanterol as needed in mild asthma compared to standard of care

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-01-14
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-11
• Study Start: 2021-12-22
• Primary Completion: 2023-01-18
• Study Completion: 2023-01-18
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard of care	Standard Preparation	Short acting beta agonist or inhaled corticosteroids
fluticasone-vilanterol	fluticasone-vilanterol	LABA-ICS A combination of Long acting beta agonist and inhaled corticosteroid

Primary Outcome Measures

Name	Time	Method
Number of asthma exacerbations	32 weeks/8 months	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)
Change in Asthma Control Score	baseline, 8 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Asthma Quality of life score	baseline, 8 months	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

Trial Locations

Locations (1)

RCSI Bahrain; 🇧🇭 Muharraq, Busaiteen, Bahrain