Effects of Omalizumab Compared to Non-Omalizumab Treatment in Asthma Patients

NCT02921178 | Unknown

• 1 other identifier: AJIRB-MED-MDB-16-276
• Study Type: observational
• Target: 124
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is effects of Omalizumab compared to non-Omalizumab treatment in the propensity-matched group on asthma exacerbation in asthma patients in Korea: a retrospective cohort in real world. Omalizumab was approved 2007 in Korea and has been used in this center. We would like to collect and analyze the data and exacerbation outcomes of these patients on Omalizumab; no Korean real world data available.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• asthma exacerbation rate

  one year

Interventions

Omalizumab OTHER

comparision of using Omalizumab and non-Omalizumab treatment

Also known as: Xolair

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult asthmatic patients(Duration of accumulated data electronic medical records)

You may qualify if:

• Codes for asthma (ICD-10: J45) dependent on availability
• Who have been diagnosed as having allergic asthma with asthma exacerbations (J45 asthma, J45.0 predominantly allergic asthma and J45.8 mixed asthma)
• Those who initially diagnosed as J45.9 asthma, unspecified, we will refer the evidence of allergic components such as IgE level and skin prick test result.
• Aged 18-80 years at index date
• Active asthma, defined as ≥ 1 prescriptions for LABA/ICS during baseline periods
• un-controlled asthma during the baseline period Any one of three criteria A. Asthma exacerbation B. Asthma-related ER visit/Hospitalization C. Physician defined un-controlled asthma
• Worsening symptom status
• Worsens on tapering of high dose ICS or systemic CS
• Air flow limitation (after appropriate bronchodilator withhold FEV1%\<80% predicted)

You may not qualify if:

• taken biologics during baseline and outcome period

Sponsors & Collaborators

• Ajou University School of Medicine: lead

MeSH Terms

Conditions

Asthma

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Hae-sim Park, Ph.D.

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ajou University Hospital

Study Record Dates

• First Submitted: September 22, 2016
• First Posted: October 3, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 3, 2016

Record last verified: 2016-09