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

Severe Asthma Clinical Trial

— SevEos  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03387722
• Other study ID #: D2287R00124
• Status: Completed
• Start date: December 31, 2017
• Est. completion date: January 3, 2019

Study information

• Verified date: September 2020
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: January 3, 2019
• Est. primary completion date: January 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Severe Asthma

Locations

Country	Name	City	State
Oman	Research Site	Muscat
United Arab Emirates	Research Site	Dubai

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Oman,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Periostin level	Mean or median of levels of Last Periostin level during the past year	1 year
Other	FeNO level	Mean or median of levels Last FeNO level during the past year	1 Year
Primary	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
Primary	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	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
Secondary	Exacerbations	Collection of exacerbations records based on history of documented Emergency Room(ER),hospital visits and hospitalizations (asthma-related)	1 year
Secondary	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
Secondary	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
Secondary	level of blood eosinophil.	Mean or median level of blood eosinophil during the past year.	1 Year
Secondary	Total serum IgE	Mean or median levels of total serum IgE during the past year.	1 Year
Secondary	Pre-bronchodilator forced expiratory volume	Pre-bronchodilator forced expiratory volume in 1 sec	1 Year
Secondary	Post-bronchodilator forced expiratory volume	Post-bronchodilator forced expiratory volume in 1 sec	1 Year
Secondary	Pre-bronchodilator expiratory forced vital capacity	Pre-bronchodilator expiratory forced vital capacity in 1 sec	1 Year
Secondary	Post-bronchodilator forced vital capacity	Post-bronchodilator forced vital capacity in 1 sec	1 Year

External Links

•   CSR Synopsis