Clinical trial NCT03387722: Assessment of Treatment Patterns of Severe Asthmatic Patients Across the Gulf Region - SevEos 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2018-01-02
Enrollment: 253
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Asthma treatment and its patterns through generic names.
timeFrame: 1 year
measure: Asthma treatment and its patterns through dosage
timeFrame: 1 Year
Secondary outcomes:
measure: Asthma Control
timeFrame: 1 year
measure: Exacerbations
timeFrame: 1 year
measure: quality of life (QoL)
timeFrame: 1 year
measure: Eosinophil count
timeFrame: 1 year
measure: level of blood eosinophil.
timeFrame: 1 Year
measure: Total serum IgE
timeFrame: 1 Year
measure: Pre-bronchodilator forced expiratory volume
timeFrame: 1 Year
measure: Post-bronchodilator forced expiratory volume
timeFrame: 1 Year
measure: Pre-bronchodilator expiratory forced vital capacity
timeFrame: 1 Year
measure: Post-bronchodilator forced vital capacity
timeFrame: 1 Year
Other outcomes:
measure: Periostin level
timeFrame: 1 year
measure: FeNO level
timeFrame: 1 Year
Locations:
city: Muscat
country: Oman
facility: Research Site
city: Dubai
country: United Arab Emirates
facility: Research Site
Study officials:
References: