BIOmarkers in Severe AsthMa Patients on Omalizumab Treatment (BIOSAMOT)

October 10, 2019 updated by: Joanna Hermanowicz-Salamon, Medical University of Warsaw

Utility of Biomarkers in Evaluating Responsiveness to Anti-IgE (Omalizumab) in Severe Asthma Patients

Eosinophil infiltration and degranulation in airways has been implicated in the pathology of asthma. Periostin is considered to be a marker of eosinophilic inflammation and is one of the highly expressed genes in epithelial cells and lung fibroblasts in asthma. Omalizumab is approved as add-on therapy in the treatment of severe allergic asthma. The aim of the study is to assess inflammatory biomarkers including: blood and sputum eosinophilia, periostin and IL-6 as long-term clinical outcomes of omalizumab therapy.

Study Overview

Status

Completed

Conditions

Detailed Description

Anti-IgE (omalizumab) has been shown to be an effective add-on therapy for patients with allergic severe asthma. In this observational study patients aged over 18 year with uncontrolled severe persistent asthma are selected for add-on therapy with omalizumab. Patients were on high dose of ICS and had a documented history of 2-6 exacerbations requiring treatment with systemic corticosteroids ( with >15 mg/day prednisone or other medications at similar dose, for at least 3 days). The individual dose and frequency of omalizumab administration is assessed from the dosing table. Lung function tests and asthma questionnaires (ACQ, AQLQ and RQLQ) are used in the aim of assessing clinical improvement after omalizumab treatment. Induced sputum (IS) and exhaled breath condensate (EBC) are used as a simple non-invasive methods for monitoring cellular and biochemical changes in the airways. Total blood eosinophil count, IS cytology, IS and EBC periostin and IL-6 concentrations are measured. Analyses are performed at entry and after 16, 52 and 104,156 weeks of omalizumab treatment.

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 00-707
        • Joanna Hermanowicz-Salamon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Severe allergic asthma

Description

Inclusion Criteria:

  1. positive history of atopy
  2. serum total IgE level between 30 and 700 IU/ml
  3. body weight not more than 150 kg
  4. high dose of ICS and LABA
  5. a documented history of 2-6 exacerbations requiring treatment with systemic corticosteroids ( with >15 mg/day prednisone or other medications at similar dose, for at least 3 days).

Exclusion Criteria:

  1. smoking
  2. pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in selected biomarkers in induced sputum
Time Frame: baseline and after 156 weeks of omalizumab treament
eosinophil count
baseline and after 156 weeks of omalizumab treament
Change in selected biomarkers in peripheral blood
Time Frame: baseline and after 156 weeks of omalizumab treament
eosinophil count
baseline and after 156 weeks of omalizumab treament
Change in selected biomarkers in induced sputum
Time Frame: baseline and after 156 weeks of omalizumab treament
periostin
baseline and after 156 weeks of omalizumab treament
Change in selected biomarkers in exhaled breath condensate
Time Frame: baseline and after 156 weeks of omalizumab treament
periostin
baseline and after 156 weeks of omalizumab treament
Change in selected biomarkers in induced sputum
Time Frame: baseline and after 156 weeks of omalizumab treament
IL-6
baseline and after 156 weeks of omalizumab treament
Change in selected biomarkers in exhaled breath condensate
Time Frame: baseline and after 156 weeks of omalizumab treament
IL-6
baseline and after 156 weeks of omalizumab treament

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in selected biomarkers in induced sputum
Time Frame: baseline and after at 16,52,104 weeks of omalizumab treament
eosinophils, periostin, IL-6
baseline and after at 16,52,104 weeks of omalizumab treament
Change in selected biomarkers in exhaled breath condensate
Time Frame: baseline and after at 16, 52, 104 weeks of omalizumab treament
periostin, IL-6
baseline and after at 16, 52, 104 weeks of omalizumab treament
Change in selected biomarkers in peripheral blood
Time Frame: baseline and after at 16, 52, 104 weeks of omalizumab treament
eosinophil count
baseline and after at 16, 52, 104 weeks of omalizumab treament

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung function tests
Time Frame: baseline and after at 16, 52, 104, 156 weeks of treament
FEV1, FVC, FEV1/FVC
baseline and after at 16, 52, 104, 156 weeks of treament

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

  • Principal Investigator: Joanna Hermanowicz-Salamon, MD,PhD, Department of Internal Medicine, Pulmonary Diseases and Allergy Medical University of Warsaw, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2013

Primary Completion (Actual)

November 5, 2018

Study Completion (Actual)

December 30, 2018

Study Registration Dates

First Submitted

November 12, 2017

First Submitted That Met QC Criteria

November 27, 2017

First Posted (Actual)

December 4, 2017

Study Record Updates

Last Update Posted (Actual)

October 11, 2019

Last Update Submitted That Met QC Criteria

October 10, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dep. of Pneum. and Allerg.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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