BIOmarkers in Severe AsthMa Patients on Omalizumab Treatment

Severe Asthma Clinical Trial

— BIOSAMOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03361111
• Other study ID #: Dep. of Pneum. and Allerg.
• Status: Completed
• Start date: April 4, 2013
• Est. completion date: December 30, 2018

Study information

• Verified date: October 2019
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 30, 2018
• Est. primary completion date: November 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Severe Asthma

Locations

Country	Name	City	State
Poland	Joanna Hermanowicz-Salamon	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (5)

Green RH, Brightling CE, McKenna S, Hargadon B, Parker D, Bradding P, Wardlaw AJ, Pavord ID. Asthma exacerbations and sputum eosinophil counts: a randomised controlled trial. Lancet. 2002 Nov 30;360(9347):1715-21. — View Citation

Hanania NA, Wenzel S, Rosén K, Hsieh HJ, Mosesova S, Choy DF, Lal P, Arron JR, Harris JM, Busse W. Exploring the effects of omalizumab in allergic asthma: an analysis of biomarkers in the EXTRA study. Am J Respir Crit Care Med. 2013 Apr 15;187(8):804-11. — View Citation

Jia G, Erickson RW, Choy DF, Mosesova S, Wu LC, Solberg OD, Shikotra A, Carter R, Audusseau S, Hamid Q, Bradding P, Fahy JV, Woodruff PG, Harris JM, Arron JR; Bronchoscopic Exploratory Research Study of Biomarkers in Corticosteroid-refractory Asthma (BOBC — View Citation

Rodrigo GJ, Neffen H, Castro-Rodriguez JA. Efficacy and safety of subcutaneous omalizumab vs placebo as add-on therapy to corticosteroids for children and adults with asthma: a systematic review. Chest. 2011 Jan;139(1):28-35. doi: 10.1378/chest.10-1194. E — View Citation

ten Brinke A, Zwinderman AH, Sterk PJ, Rabe KF, Bel EH. Factors associated with persistent airflow limitation in severe asthma. Am J Respir Crit Care Med. 2001 Sep 1;164(5):744-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lung function tests	FEV1, FVC, FEV1/FVC	baseline and after at 16, 52, 104, 156 weeks of treament
Primary	Change in selected biomarkers in induced sputum	eosinophil count	baseline and after 156 weeks of omalizumab treament
Primary	Change in selected biomarkers in peripheral blood	eosinophil count	baseline and after 156 weeks of omalizumab treament
Primary	Change in selected biomarkers in induced sputum	periostin	baseline and after 156 weeks of omalizumab treament
Primary	Change in selected biomarkers in exhaled breath condensate	periostin	baseline and after 156 weeks of omalizumab treament
Primary	Change in selected biomarkers in induced sputum	IL-6	baseline and after 156 weeks of omalizumab treament
Primary	Change in selected biomarkers in exhaled breath condensate	IL-6	baseline and after 156 weeks of omalizumab treament
Secondary	Change in selected biomarkers in induced sputum	eosinophils, periostin, IL-6	baseline and after at 16,52,104 weeks of omalizumab treament
Secondary	Change in selected biomarkers in exhaled breath condensate	periostin, IL-6	baseline and after at 16, 52, 104 weeks of omalizumab treament
Secondary	Change in selected biomarkers in peripheral blood	eosinophil count	baseline and after at 16, 52, 104 weeks of omalizumab treament