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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03387722 |
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Date of registration:
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11/12/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Assessment of Treatment Patterns of Severe Asthmatic Patients Across the Gulf Region - SevEos Study
SevEos |
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Scientific title:
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Assessment of Treatment Patterns of Severe Asthmatic Patients Across the Gulf Region - SevEos Study SevEos is a Cross-sectional, Multi-center, Non-interventional Study Aimed to Describe the Treatment Patterns in 250 Severe Asthma Patients Across the Gulf Region. |
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Date of first enrolment:
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December 31, 2017 |
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Target sample size:
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253 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03387722 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Kuwait
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Oman
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Qatar
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United Arab Emirates
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Key inclusion & exclusion criteria
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Inclusion Criteria:
To be included in this study, patients (both male and female) must fulfill all of the
following criteria:
1. Age above 12 years.
2. Body weight of =40 kg.
3. Diagnosed by a physician with severe asthma, who requires regular treatment with
medium or high dosage Inhaled Corticosteroids (ICS) (patients aged 12-17 years) OR
high-dosage ICS ( plus Long-Acting Beta Agonist (LABA) for at least 1 year before
enrolment.
[Note that the value of the medium/high dosage is dependent on the type of ICS
Exclusion Criteria:
Patients who meet any of the following criteria are ineligible to participate in the study:
1. Patient refuses to consent.
2. Another clinically important pulmonary disease is considered to be the primary
diagnosis, other than severe asthma (i.e.: COPD, major bronchiectasis, active
tuberculosis, and other conditions considered by the principal investigator).
3. Mentally disabled patient or inability to understand the study questions.
4. Unable to read/write.
Age minimum:
12 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Severe Asthma
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Primary Outcome(s)
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Asthma treatment and its patterns through generic names.
[Time Frame: 1 year]
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Asthma treatment and its patterns through dosage
[Time Frame: 1 Year]
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Secondary Outcome(s)
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Exacerbations
[Time Frame: 1 year]
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Pre-bronchodilator expiratory forced vital capacity
[Time Frame: 1 Year]
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Eosinophil count
[Time Frame: 1 year]
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Post-bronchodilator forced expiratory volume
[Time Frame: 1 Year]
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Post-bronchodilator forced vital capacity
[Time Frame: 1 Year]
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Pre-bronchodilator forced expiratory volume
[Time Frame: 1 Year]
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Asthma Control
[Time Frame: 1 year]
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level of blood eosinophil.
[Time Frame: 1 Year]
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Total serum IgE
[Time Frame: 1 Year]
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quality of life (QoL)
[Time Frame: 1 year]
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Secondary ID(s)
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D2287R00124
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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