NCT04265105

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2 asthma

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
1.9 years until next milestone

Study Start

First participant enrolled

December 22, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2023

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

January 14, 2020

Last Update Submit

March 28, 2023

Conditions

Asthma

Keywords

asthmafluticasoneLABAfluticasone-vilanterolLong acting Beta agonist

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Change in Asthma Quality of life score

    baseline, 8 months

Study Arms (2)

standard of care

ACTIVE COMPARATOR

Short acting beta agonist or inhaled corticosteroids

Drug: Standard Preparation

fluticasone-vilanterol

EXPERIMENTAL

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

Drug: fluticasone-vilanterol

Interventions

fluticasone-vilanterolDRUG

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

fluticasone-vilanterol
Standard PreparationDRUG

inhaled SABA or Inhaled corticosteroid

Also known as: standard of care
standard of care

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RCSI Bahrain

Al Muharraq, Busaiteen, Bahrain

Location

MeSH Terms

Conditions

Asthma

Interventions

fluticasone furoate-vilanterol trifenatateReference StandardsStandard of Care

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Weights and MeasuresInvestigative TechniquesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 14, 2020

First Posted

February 11, 2020

Study Start

December 22, 2021

Primary Completion

January 18, 2023

Study Completion

January 18, 2023

Last Updated

March 31, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Study documents (paper and electronic) will be retained in a secure (kept locked when not in use) location during and after the trial has finished. All essential documents including source documents will be retained for a period of 3 years after study completion (last patient, last visit). A label stating the date after which the documents can be destroyed will be placed on the inside front cover of the case notes of trial participants.Monitoring, audits, and REC review will be permitted and provide direct access to source data and documents. The Lead PI and the researcher assigned by her will have access to the stored data. Only the CRCs and Lead PI working on this study will be eligible to obtain the data from the participants during data collection visits.

Locations

BA(1)