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NCT Number: NCT03387722

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. 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.

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Key information

Conditions

Severe Asthma Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Muscat, Oman

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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

  1. Asthma Control

    Time frame: 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.

  2. Exacerbations

    Time frame: 1 year

    Collection of exacerbations records based on history of documented Emergency Room(ER),hospital visits and hospitalizations (asthma-related)

  3. quality of life (QoL)

    Time frame: 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).

  4. Eosinophil count

    Time frame: 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.

  5. level of blood eosinophil.

    Time frame: 1 Year

    Mean or median level of blood eosinophil during the past year.

  6. Total serum IgE

    Time frame: 1 Year

    Mean or median levels of total serum IgE during the past year.

  7. Pre-bronchodilator forced expiratory volume

    Time frame: 1 Year

    Pre-bronchodilator forced expiratory volume in 1 sec

  8. Post-bronchodilator forced expiratory volume

    Time frame: 1 Year

    Post-bronchodilator forced expiratory volume in 1 sec

  9. Pre-bronchodilator expiratory forced vital capacity

    Time frame: 1 Year

    Pre-bronchodilator expiratory forced vital capacity in 1 sec

  10. Post-bronchodilator forced vital capacity

    Time frame: 1 Year

    Post-bronchodilator forced vital capacity in 1 sec

Other outcomes

  1. Periostin level

    Time frame: 1 year

    Mean or median of levels of Last Periostin level during the past year

  2. FeNO level

    Time frame: 1 Year

    Mean or median of levels Last FeNO level during the past year

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Acronym: SevEos

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 2, 2018
Registry last updated
Sep 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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