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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 253
- Locations
- 1
- Primary Endpoint
- Asthma treatment and its patterns through generic names.
Study Overview
Brief Summary
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. In addition, the study will determine the current level of asthma control and quality of life in these patients; describe the exacerbation patterns; and determine the current levels of blood eosinophils for the enrolled patients.
Detailed Description
The primary objective of this study is to describe the treatments patterns of severe asthmatic patients across four Gulf countries during the past year.
Secondary Objectives
- To determine the current level of asthma control in these patients. In addition, a comparison of uncontrolled asthma between those with a eosinophilic count ≥ 300 cell/μl and those with an elevated eosinophilic count less than that.
- To determine the current and past year levels of blood eosinophils, and the percentage of patients with elevated eosinophilic level ≥ 150 cells/μL and ≥ 300 cells/μL
- To describe the frequency of exacerbations during the past year.
- To assess the current quality of life (QoL) of these patients.
- To determine the past year levels of serum IgE.
- Exploratory objective: To determine the past year levels of other inflammatory biomarkers like periostin and fraction of exhaled nitric oxide (FeNO).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •To be included in this study, patients (both male and female) must fulfill all of the following criteria:
- •Age above 12 years.
- •Body weight of ≥40 kg.
- •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:
- •Patient refuses to consent.
- •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).
- •Mentally disabled patient or inability to understand the study questions.
- •Unable to read/write.
Outcomes
Primary Outcomes
Asthma treatment and its patterns through generic names.
Time Frame: 1 year
Changes in Asthma treatment stages during the last year based on the number of prescribed: * Short-acting: muscarinic antagonists (SAMA), * long-acting muscarinic antagonists (LAMA), * Long-acting Beta agonist (LABA), * Corticosteroids (Inhaled(ICS), Oral(OCS) \& Parental), * Theophylline, * Biologics.
Asthma treatment and its patterns through dosage
Time Frame: 1 Year
Changes in Asthma treatment stages during the last year based on the dosage: * Short-acting: muscarinic antagonists (SAMA), * long-acting muscarinic antagonists (LAMA), * Long-acting Beta agonist (LABA), * Corticosteroids (Inhaled(ICS), Oral(OCS) \& Parental), * Theophylline, * Biologics.
Secondary Outcomes
- quality of life (QoL)(1 year)
- Pre-bronchodilator forced expiratory volume(1 Year)
- Post-bronchodilator forced expiratory volume(1 Year)
- Exacerbations(1 year)
- Total serum IgE(1 Year)
- Pre-bronchodilator expiratory forced vital capacity(1 Year)
- Eosinophil count(1 year)
- level of blood eosinophil.(1 Year)
- Post-bronchodilator forced vital capacity(1 Year)
- Asthma Control(1 year)