Assessment of Treatment Patterns of Severe Asthmatic Patients Across the Gulf Region

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

253 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-31

Study Completion Date

2019-01-03

Brief Summary

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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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Detailed Description

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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).

Conditions

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Severe Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No