AsthmaPhase 2/3NCT04265105
Fluticasone-Vilanterol Once Daily Dose for the Treatment of Mild Asthma in Adults
A Phase 2/3 study testing fluticasone-vilanterol and Standard Preparation in people with Asthma, run by Royal College of Surgeons in Ireland - Medical University of Bahrain at 1 site in Bahrain.
Trial summary
Investigators will test the superiority of Superiority Trial of Fluticasone-Vilanterol as needed in mild asthma compared to standard of care Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- fluticasone-vilanterol and Standard Preparation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBahrain
- Study dates
- 22 Dec 2021to 18 Jan 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Asthma
- Being tested
- fluticasone-vilanterol, Standard Preparation
- Keywords
- asthma, fluticasone, LABA, fluticasone-vilanterol, Long acting Beta agonist
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluticasone-vilanterolDrug
LABA-ICS combination Inhaled Long acting Beta agonist and inhaled corticosteroid
Standard PreparationDrug
Also called standard of care
inhaled SABA or Inhaled corticosteroid
| Study group | Role | What they receive |
|---|---|---|
| standard of care | Active comparator | Short acting beta agonist or inhaled corticosteroids Receives: Drug: Standard Preparation |
| fluticasone-vilanterol | Experimental | LABA-ICS A combination of Long acting beta agonist and inhaled corticosteroid Receives: Drug: fluticasone-vilanterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: baseline, 8 months
Secondary outcomes (1)
Change in Asthma Quality of life score
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
Measured: baseline, 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start22 Dec 2021
- Primary completion18 Jan 2023
- Study completion18 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons in Ireland - Medical University of Bahrain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Ghufran Jassim, Royal College of Surgeons in Ireland - Medical University of Bahrain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265105
- Sponsor's protocol ID
- RCSIBahrain
- Status last verified
- Mar 2023
- First submitted
- 14 Jan 2020
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomised Controlled Superiority Trial of Fluticasone-Vilanterol Once Daily Dose for the Treatment of Mild Asthma in Adults
- ClinicalTrials.gov ID
- NCT04265105
- Acronym / sponsor ID
- RCSIBahrain
- Conditions
- Asthma
- Keywords
- asthma, fluticasone, LABA, fluticasone-vilanterol, Long acting Beta agonist
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Royal College of Surgeons in Ireland - Medical University of BahrainUniversity, hospital or other
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators will test the superiority of Superiority Trial of Fluticasone-Vilanterol as needed in mild asthma compared to standard of care
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| standard of care | Active comparator | Drug: Standard PreparationShort acting beta agonist or inhaled corticosteroids |
| fluticasone-vilanterol | Experimental | Drug: fluticasone-vilanterolLABA-ICS A combination of Long acting beta agonist and inhaled corticosteroid |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluticasone-vilanterolLABA-ICS combination Inhaled Long acting Beta agonist and inhaled corticosteroid | Drug | fluticasone-vilanterol |
| Standard PreparationAlso: standard of careinhaled SABA or Inhaled corticosteroid | Drug | standard of care |
Primary outcome
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)
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.
1 secondary outcome
Change in Asthma Quality of life score
Time frame: baseline, 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing fluticasone-vilanterol and Standard Preparation in people with Asthma, run by Royal College of Surgeons in Ireland - Medical University of Bahrain at 1 site in Bahrain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bahrain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of asthma exacerbations (time frame: 32 weeks/8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.