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

NCT03387722 | Completed

• 1 other identifier: D2287R00124
• Study Type: observational
• Target: 253
• Locations: 2 countries
• Sites: 2

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.

Conditions

Severe Asthma

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  1 Year

Secondary Outcomes (10)

• Asthma Control

  1 year

• Exacerbations

  1 year

• quality of life (QoL)

  1 year

• Eosinophil count

  1 year

• level of blood eosinophil.

  1 Year

Other Outcomes (2)

• Periostin level

  1 year

• FeNO level

  1 Year

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Research Site

Muscat, 111, Oman

Location

Research Site

Dubai, United Arab Emirates

Location

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: January 2, 2018
• Study Start: December 31, 2017
• Primary Completion: January 3, 2019
• Study Completion: January 3, 2019
• Last Updated: September 10, 2020

Record last verified: 2020-09

Locations

AE (1); OM (1)