Assessment of Treatment Patterns of Severe Asthmatic Patients Across the Gulf Region - SevEos Study (SevEos)

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.

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.

Study Overview

• Status: Completed
• Conditions: Severe Asthma

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).

• Study Type: Observational
• Enrollment (Actual): 253

Contacts and Locations

Study Locations

• Oman
  • Muscat, Oman, 111
    • Research Site
• United Arab Emirates
  • Dubai, United Arab Emirates
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma treatment and its patterns through generic names.	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.	1 year
Asthma treatment and its patterns through dosage	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.	1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma Control	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.	1 year
Exacerbations	Collection of exacerbations records based on history of documented Emergency Room(ER),hospital visits and hospitalizations (asthma-related)	1 year
quality of life (QoL)	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).	1 year
Eosinophil count	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.	1 year
level of blood eosinophil.	Mean or median level of blood eosinophil during the past year.	1 Year
Total serum IgE	Mean or median levels of total serum IgE during the past year.	1 Year
Pre-bronchodilator forced expiratory volume	Pre-bronchodilator forced expiratory volume in 1 sec	1 Year
Post-bronchodilator forced expiratory volume	Post-bronchodilator forced expiratory volume in 1 sec	1 Year
Pre-bronchodilator expiratory forced vital capacity	Pre-bronchodilator expiratory forced vital capacity in 1 sec	1 Year
Post-bronchodilator forced vital capacity	Post-bronchodilator forced vital capacity in 1 sec	1 Year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periostin level	Mean or median of levels of Last Periostin level during the past year	1 year
FeNO level	Mean or median of levels Last FeNO level during the past year	1 Year

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2017
• Primary Completion (Actual): January 3, 2019
• Study Completion (Actual): January 3, 2019

Study Registration Dates

• First Submitted: December 11, 2017
• First Submitted That Met QC Criteria: December 22, 2017
• First Posted (Actual): January 2, 2018

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: D2287R00124

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No