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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard of care | Active Comparator | Short acting beta agonist or inhaled corticosteroids |
|
| fluticasone-vilanterol | Experimental | LABA-ICS A combination of Long acting beta agonist and inhaled corticosteroid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluticasone-vilanterol | Drug | LABA-ICS combination Inhaled Long acting Beta agonist and inhaled corticosteroid |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline, 8 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RCSI Bahrain | Al Muharraq | Busaiteen | Bahrain |
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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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C000611924 | fluticasone furoate-vilanterol trifenatate |
| D012015 | Reference Standards |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D014894 | Weights and Measures |
| D008919 | Investigative Techniques |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
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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.
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| Standard Preparation | Drug | inhaled SABA or Inhaled corticosteroid |
|
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |