Assessment of Treatment Patterns of Severe Asthmatic Patients Across the Gulf Region - SevEos Study
- Conditions
- Severe Asthma
- Registration Number
- NCT03387722
- Lead Sponsor
- AstraZeneca
- 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
1. 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.
2. 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
3. To describe the frequency of exacerbations during the past year.
4. To assess the current quality of life (QoL) of these patients.
5. To determine the past year levels of serum IgE.
6. Exploratory objective: To determine the past year levels of other inflammatory biomarkers like periostin and fraction of exhaled nitric oxide (FeNO).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 253
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
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Asthma treatment and its patterns through generic names. 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 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 Outcome Measures
Name Time Method quality of life (QoL) 1 year Quality of life will be assed using "Asthma Quality of life Questionnaire with Standardised Activities", a questionnaire developed by Elizabeth Juniper( MCSP, MSc Professor, 20 Marcuse Fields Bosham, West Sussex PO18 8NA, England) to measure the functional problems (physical, emotional, social and occupational) that are most troublesome for patients with asthma. There are 32 questions in the questoinnaire and they are in 4 domains (symptoms, activity limitation, emotional function and environmental stimuli). Patients are asked during the previous two weeks and to respond to 32 questions on a 7-point scale (7 = not impaired at all - 1 = severely impaired). Scores range 1-7, higher scores indicating better quality of life. The better outcome is of higher score value, 0 (totally controlled), 6 (severely uncontrolled).
Pre-bronchodilator forced expiratory volume 1 Year Pre-bronchodilator forced expiratory volume in 1 sec
Post-bronchodilator forced expiratory volume 1 Year Post-bronchodilator forced expiratory volume in 1 sec
Exacerbations 1 year Collection of exacerbations records based on history of documented Emergency Room(ER),hospital visits and hospitalizations (asthma-related)
Total serum IgE 1 Year Mean or median levels of total serum IgE during the past year.
Pre-bronchodilator expiratory forced vital capacity 1 Year Pre-bronchodilator expiratory forced vital capacity in 1 sec
Eosinophil count 1 year Proportion of severe asthmatics with eosinophil count (threshold ≥150cells/μL and ≥300 cells/μL) based on current/most recent blood eosinophil level during the past year.
level of blood eosinophil. 1 Year Mean or median level of blood eosinophil during the past year.
Post-bronchodilator forced vital capacity 1 Year Post-bronchodilator forced vital capacity in 1 sec
Asthma Control 1 year Asthma control will be assed using "The Asthma Control Questionnaire". The questionnaire was developed by Elizabeth Juniper( MCSP, MSc Professor, 20 Marcuse Fields) Bosham, West Sussex PO18 8NA, England), to measure both the adequacy of asthma control and change in asthma control, which occurs either spontaneously or as a result of treatment.
Patients are asked to respond to questions on a 7-point scale (0=no impairment, 6= maximum impairment). The questions are equally weighted and the ACQ score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). A change or difference in score of 0.5 is the smallest that can be considered clinically important.
Trial Locations
- Locations (1)
Research Site
🇦🇪Dubai, United Arab Emirates