- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04265105
Fluticasone-Vilanterol Once Daily Dose for the Treatment of Mild Asthma in Adults
March 28, 2023 updated by: Dr Ghufran Jassim, Royal College of Surgeons in Ireland - Medical University of Bahrain
A Pilot Randomised Controlled Superiority Trial of 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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Busaiteen
-
Muharraq, Busaiteen, Bahrain
- RCSI Bahrain
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: standard of care
Short acting beta agonist or inhaled corticosteroids
|
inhaled SABA or Inhaled corticosteroid
Other Names:
|
Experimental: fluticasone-vilanterol
LABA-ICS A combination of Long acting beta agonist and inhaled corticosteroid
|
LABA-ICS combination Inhaled Long acting Beta agonist and inhaled corticosteroid
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
32 weeks/8 months
|
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.
|
baseline, 8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
baseline, 8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 22, 2021
Primary Completion (Actual)
January 18, 2023
Study Completion (Actual)
January 18, 2023
Study Registration Dates
First Submitted
January 14, 2020
First Submitted That Met QC Criteria
February 10, 2020
First Posted (Actual)
February 11, 2020
Study Record Updates
Last Update Posted (Actual)
March 31, 2023
Last Update Submitted That Met QC Criteria
March 28, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Fluticasone
Other Study ID Numbers
- RCSIBahrain
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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