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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04265105
• Other study ID #: RCSIBahrain
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 22, 2021
• Est. completion date: January 18, 2023

Study information

• Verified date: March 2023
• Source: Royal College of Surgeons in Ireland - Medical University of Bahrain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 18, 2023
• Est. primary completion date: January 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• fluticasone-vilanterol
LABA-ICS combination Inhaled Long acting Beta agonist and inhaled corticosteroid
• Standard Preparation
inhaled SABA or Inhaled corticosteroid

Locations

Country	Name	City	State
Bahrain	RCSI Bahrain	Muharraq	Busaiteen

Sponsors (1)

Lead Sponsor	Collaborator
Royal College of Surgeons in Ireland - Medical University of Bahrain

Country where clinical trial is conducted

Bahrain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	32 weeks/8 months
Primary	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.	baseline, 8 months
Secondary	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	baseline, 8 months