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Completed

NCT Number: NCT04265105

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

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

RCSI Bahrain

Al Muharraq, Busaiteen, Bahrain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fluticasone-vilanterol

Drug

LABA-ICS combination Inhaled Long acting Beta agonist and inhaled corticosteroid

Standard Preparation

Drug

inhaled SABA or Inhaled corticosteroid

Other names: standard of care

Primary outcomes

  1. Number of asthma exacerbations

    Time frame: 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)

  2. Change in Asthma Control Score

    Time frame: 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 outcomes

  1. Change in Asthma Quality of life score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Royal College of Surgeons in Ireland - Medical University of Bahrain

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 11, 2020
Registry last updated
Mar 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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