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

Royal College of Surgeons in Ireland - Medical University of Bahrain

Status and phase: Completed; Phase 3; Phase 2

Conditions: Asthma

Treatments: Drug: fluticasone-vilanterol; Drug: Standard Preparation

Study type: Interventional

Funder types: Other

Identifiers

NCT04265105

RCSIBahrain

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

standard of care

Active Comparator group

Description:

Short acting beta agonist or inhaled corticosteroids

Treatment:

Drug: Standard Preparation

fluticasone-vilanterol

Experimental group

Description:

LABA-ICS A combination of Long acting beta agonist and inhaled corticosteroid

Treatment:

Drug: fluticasone-vilanterol