Severe AsthmaSevEosNCT03387722
Assessment of Treatment Patterns of Severe Asthmatic Patients Across the Gulf Region - SevEos Study
An observational study of Severe Asthma, run by AstraZeneca at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Severe Asthma
- How many people
- 253 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 31 Dec 2017to 3 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
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
- 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).
- Conditions
- Severe Asthma
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 Year
Secondary outcomes (10)
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.
Measured: 1 year
Exacerbations
Collection of exacerbations records based on history of documented Emergency Room(ER),hospital visits and hospitalizations (asthma-related)
Measured: 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).
Measured: 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.
Measured: 1 year
level of blood eosinophil.
Mean or median level of blood eosinophil during the past year.
Measured: 1 Year
Total serum IgE
Mean or median levels of total serum IgE during the past year.
Measured: 1 Year
Pre-bronchodilator forced expiratory volume
Pre-bronchodilator forced expiratory volume in 1 sec
Measured: 1 Year
Post-bronchodilator forced expiratory volume
Post-bronchodilator forced expiratory volume in 1 sec
Measured: 1 Year
Pre-bronchodilator expiratory forced vital capacity
Pre-bronchodilator expiratory forced vital capacity in 1 sec
Measured: 1 Year
Post-bronchodilator forced vital capacity
Post-bronchodilator forced vital capacity in 1 sec
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start31 Dec 2017
- Primary completion3 Jan 2019
- Study completion3 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387722
- Sponsor's protocol ID
- D2287R00124
- Acronym
- SevEos
- Status last verified
- Sep 2020
- First submitted
- 11 Dec 2017
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03387722
- Acronym / sponsor ID
- SevEos / D2287R00124
- Conditions
- Severe Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2017 (actual)
- Primary completion
- 3 Jan 2019 (actual)
- Study completion
- 3 Jan 2019 (actual)
- First posted
- 2 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
10 secondary outcomes
Asthma Control
Time frame: 1 year
Exacerbations
Time frame: 1 year
quality of life (QoL)
Time frame: 1 year
Eosinophil count
Time frame: 1 year
level of blood eosinophil.
Time frame: 1 Year
Total serum IgE
Time frame: 1 Year
Pre-bronchodilator forced expiratory volume
Time frame: 1 Year
Post-bronchodilator forced expiratory volume
Time frame: 1 Year
Pre-bronchodilator expiratory forced vital capacity
Time frame: 1 Year
Post-bronchodilator forced vital capacity
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- CSR SynopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Asthma, run by AstraZeneca at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Oman, United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma treatment and its patterns through generic names. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.