BIOmarkers in Severe AsthMa Patients on Omalizumab Treatment

NCT03361111 | Completed DMC

• 1 other identifier: Dep. of Pneum. and Allerg.
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Asthma

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Change in selected biomarkers in induced sputum

  eosinophil count

  baseline and after 156 weeks of omalizumab treament

• Change in selected biomarkers in peripheral blood

  eosinophil count

  baseline and after 156 weeks of omalizumab treament

• Change in selected biomarkers in induced sputum

  periostin

  baseline and after 156 weeks of omalizumab treament

• Change in selected biomarkers in exhaled breath condensate

  periostin

  baseline and after 156 weeks of omalizumab treament

• Change in selected biomarkers in induced sputum

  IL-6

  baseline and after 156 weeks of omalizumab treament

• Change in selected biomarkers in exhaled breath condensate

  IL-6

  baseline and after 156 weeks of omalizumab treament

Secondary Outcomes (3)

• Change in selected biomarkers in induced sputum

  baseline and after at 16,52,104 weeks of omalizumab treament

• Change in selected biomarkers in exhaled breath condensate

  baseline and after at 16, 52, 104 weeks of omalizumab treament

• Change in selected biomarkers in peripheral blood

  baseline and after at 16, 52, 104 weeks of omalizumab treament

Other Outcomes (1)

• Lung function tests

  baseline and after at 16, 52, 104, 156 weeks of treament

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Severe allergic asthma

You may qualify if:

• positive history of atopy
• serum total IgE level between 30 and 700 IU/ml
• body weight not more than 150 kg
• high dose of ICS and LABA
• 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).

You may not qualify if:

• smoking
• pregnancy

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Joanna Hermanowicz-Salamon

Warsaw, 00-707, Poland

Location

Related Publications (5)

• 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. Epub 2010 Aug 5.

  PMID: 20688929 RESULT

• Hanania NA, Wenzel S, Rosen 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. doi: 10.1164/rccm.201208-1414OC.

  PMID: 23471469 RESULT

• 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. doi: 10.1164/ajrccm.164.5.2011026.

  PMID: 11549526 RESULT

• 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. doi: 10.1016/S0140-6736(02)11679-5.

  PMID: 12480423 RESULT

• 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 (BOBCAT) Study Group. Periostin is a systemic biomarker of eosinophilic airway inflammation in asthmatic patients. J Allergy Clin Immunol. 2012 Sep;130(3):647-654.e10. doi: 10.1016/j.jaci.2012.06.025. Epub 2012 Aug 1.

  PMID: 22857879 RESULT

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 Officials

• Joanna Hermanowicz-Salamon, MD,PhD

  Department of Internal Medicine, Pulmonary Diseases and Allergy Medical University of Warsaw, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: November 12, 2017
• First Posted: December 4, 2017
• Study Start: April 4, 2013
• Primary Completion: November 5, 2018
• Study Completion: December 30, 2018
• Last Updated: October 11, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)