ClinicalTrials.gg
CompletedNCT03387722SevEosUpdated Sep 10, 2020

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

An observational study in Severe Asthma, sponsored by AstraZeneca. Completed at 2 sites in 2 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2020-09-10.

Sponsored by AstraZeneca · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
253
Ages
12 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 359 studies in Asthma by AstraZeneca — 19 open to participants now, 28 under way, 8 of them phase 3. Asthma · AstraZeneca.

Enrollment
82nd of 110
253 · median 500
Started
2017
with 12 others
Observational
111 of 359
9 open now
Registered
233rd of 359
by date

Among the 359 studies in Asthma by AstraZeneca, this one is the 82nd largest by enrollment of the 110 observational ones that give a count, is one of 13 that started in 2017, is one of 111 observational ones, and was the 233rd registered.

Asthma

4,846 studies on the registry are indexed under Asthma; 603 are open to participants now.

Browse Asthma studies →

Open to participants now

19 of the 359 studies in Asthma by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:

14 more — sign in →

By country, each count listing its studies:

All 19 open studies →

Who these studies take

Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 147 take children under 18; 105 take healthy volunteers.

This study: 12 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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).
03

Conditions studied

  • Severe Asthma

Browse trials for

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (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

Exclusion Criteria:

Patients who meet any of the following criteria are ineligible to participate in the study:

  1. Patient refuses to consent.
  2. Another pulmonary disease is considered to be the primary diagnosis, other than severe asthma (i.e.: , 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
253 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

  2. 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.

    Time frame: 1 Year

Secondary outcomes

  1. 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.

    Time frame: 1 year

  2. Exacerbations

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

    Time frame: 1 year

  3. 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).

    Time frame: 1 year

  4. 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.

    Time frame: 1 year

  5. level of blood eosinophil.

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

    Time frame: 1 Year

  6. Total serum IgE

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

    Time frame: 1 Year

  7. Pre-bronchodilator forced expiratory volume

    Pre-bronchodilator forced expiratory volume in 1 sec

    Time frame: 1 Year

  8. Post-bronchodilator forced expiratory volume

    Post-bronchodilator forced expiratory volume in 1 sec

    Time frame: 1 Year

  9. Pre-bronchodilator expiratory forced vital capacity

    Pre-bronchodilator expiratory forced vital capacity in 1 sec

    Time frame: 1 Year

  10. Post-bronchodilator forced vital capacity

    Post-bronchodilator forced vital capacity in 1 sec

    Time frame: 1 Year

Other outcomes

  1. Periostin level

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

    Time frame: 1 year

  2. FeNO level

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

    Time frame: 1 Year

07

Study locations

2 sites
  • Research Site
    Muscat, 111, Oman
  • Research Site
    Dubai, United Arab Emirates
08

References and documents

Related links

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2017 to primary completion in Jan 2019, 12 months.

Of 90 industry-sponsored observational studies under Asthma, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 58. This study's 12 months is below that.

Counting every sponsor, half of 455 studies reached it within 36 months; a quarter within 18 and three quarters within 82.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 11, 2017
First posted
Jan 2, 2018
StartActual
Dec 31, 2017
Primary completionActual
Jan 3, 2019
CompletionActual
Jan 3, 2019
Last update
Sep 10, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03387722
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Jan 2, 2018
Start date
Dec 31, 2017
Primary completion
Jan 3, 2019
Completion
Jan 3, 2019
Last update
Sep 10, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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