BIOmarkers in Severe AsthMa Patients on Omalizumab Treatment

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03361111

Acronym

BIOSAMOT

Enrollment

Registered

2017-12-04

Start date

2013-04-04

Completion date

2018-12-30

Last updated

2019-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Asthma

Keywords

severe asthma, anti-IgE, periostin, induced sputum,, exhaled breath condensate

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in selected biomarkers in exhaled breath condensate	baseline and after 156 weeks of omalizumab treament	periostin
Change in selected biomarkers in induced sputum	baseline and after 156 weeks of omalizumab treament	eosinophil count
Change in selected biomarkers in peripheral blood	baseline and after 156 weeks of omalizumab treament	eosinophil count

Secondary

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

Other

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

Countries

Poland

Outcome results