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

NCT ID: NCT04265105

Last Updated: 2023-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-22

Study Completion Date

2023-01-18

Brief Summary

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

Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Investigators will compare the superiority of effectiveness and safety of fluticasone-vilanterol versus usual care. In this study, there is a random allocation of participants to usual care (Any ICS or SABA combination) or fluticasone-vilanterol single daily use for the relief of symptoms.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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standard of care

Short acting beta agonist or inhaled corticosteroids

Group Type ACTIVE_COMPARATOR

Standard Preparation

Intervention Type DRUG

inhaled SABA or Inhaled corticosteroid

fluticasone-vilanterol

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

Group Type EXPERIMENTAL

fluticasone-vilanterol

Intervention Type DRUG

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

Interventions

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fluticasone-vilanterol

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

Intervention Type DRUG

Standard Preparation

inhaled SABA or Inhaled corticosteroid

Intervention Type DRUG

Other Intervention Names

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standard of care

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal College of Surgeons in Ireland - Medical University of Bahrain

OTHER

Sponsor Role lead

Responsible Party

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Dr Ghufran Jassim

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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RCSI Bahrain

Al Muharraq, Busaiteen, Bahrain

Site Status

Countries

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Bahrain

Other Identifiers

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RCSIBahrain

Identifier Type: -

Identifier Source: org_study_id

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