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BIOmarkers in Severe AsthMa Patients on Omalizumab Treatment (BIOSAMOT)

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ClinicalTrials.gov Identifier: NCT03361111
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):
Joanna Hermanowicz-Salamon, Medical University of Warsaw

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.

Condition or disease
Severe Asthma

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
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Utility of Biomarkers in Evaluating Responsiveness to Anti-IgE (Omalizumab) in Severe Asthma Patients
Actual Study Start Date : April 4, 2013
Estimated Primary Completion Date : May 5, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Omalizumab
U.S. FDA Resources




Primary Outcome Measures :
  1. Change in selected biomarkers in induced sputum [ Time Frame: baseline and after 156 weeks of omalizumab treament ]
    eosinophil count

  2. Change in selected biomarkers in peripheral blood [ Time Frame: baseline and after 156 weeks of omalizumab treament ]
    eosinophil count

  3. Change in selected biomarkers in induced sputum [ Time Frame: baseline and after 156 weeks of omalizumab treament ]
    periostin

  4. Change in selected biomarkers in exhaled breath condensate [ Time Frame: baseline and after 156 weeks of omalizumab treament ]
    periostin

  5. Change in selected biomarkers in induced sputum [ Time Frame: baseline and after 156 weeks of omalizumab treament ]
    IL-6

  6. Change in selected biomarkers in exhaled breath condensate [ Time Frame: baseline and after 156 weeks of omalizumab treament ]
    IL-6


Secondary Outcome Measures :
  1. Change in selected biomarkers in induced sputum [ Time Frame: baseline and after at 16,52,104 weeks of omalizumab treament ]
    eosinophils, periostin, IL-6

  2. Change in selected biomarkers in exhaled breath condensate [ Time Frame: baseline and after at 16, 52, 104 weeks of omalizumab treament ]
    periostin, IL-6

  3. Change in selected biomarkers in peripheral blood [ Time Frame: baseline and after at 16, 52, 104 weeks of omalizumab treament ]
    eosinophil count


Other Outcome Measures:
  1. Lung function tests [ Time Frame: baseline and after at 16, 52, 104, 156 weeks of treament ]
    FEV1, FVC, FEV1/FVC



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Severe allergic asthma
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03361111


Contacts
Contact: Joanna Hermanowicz-Salamon, MD, PhD + 48 225992599 jhermanowiczsalamon@gmail.com
Contact: Rafał Krenke, MD, PhD, Prof +48 225992562

Locations
Poland
Joanna Hermanowicz-Salamon Recruiting
Warsaw, Poland, 00-707
Contact: Joanna Hermanowicz-Salamon, MD PhD    606635722    jhermanowiczsalamon@gmail.com   
Sponsors and Collaborators
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 of Results:
Responsible Party: Joanna Hermanowicz-Salamon, MD PhD, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03361111     History of Changes
Other Study ID Numbers: Dep. of Pneum. and Allerg.
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joanna Hermanowicz-Salamon, Medical University of Warsaw:
severe asthma
anti-IgE
periostin
induced sputum,
exhaled breath condensate

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents