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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 : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Joanna Hermanowicz-Salamon, Medical University of Warsaw

November 12, 2017
December 4, 2017
October 5, 2018
April 4, 2013
November 5, 2018   (Final data collection date for primary outcome measure)
  • Change in selected biomarkers in induced sputum [ Time Frame: baseline and after 156 weeks of omalizumab treament ]
    eosinophil count
  • Change in selected biomarkers in peripheral blood [ Time Frame: baseline and after 156 weeks of omalizumab treament ]
    eosinophil count
  • Change in selected biomarkers in induced sputum [ Time Frame: baseline and after 156 weeks of omalizumab treament ]
    periostin
  • Change in selected biomarkers in exhaled breath condensate [ Time Frame: baseline and after 156 weeks of omalizumab treament ]
    periostin
  • Change in selected biomarkers in induced sputum [ Time Frame: baseline and after 156 weeks of omalizumab treament ]
    IL-6
  • Change in selected biomarkers in exhaled breath condensate [ Time Frame: baseline and after 156 weeks of omalizumab treament ]
    IL-6
Same as current
Complete list of historical versions of study NCT03361111 on ClinicalTrials.gov Archive Site
  • Change in selected biomarkers in induced sputum [ Time Frame: baseline and after at 16,52,104 weeks of omalizumab treament ]
    eosinophils, periostin, IL-6
  • Change in selected biomarkers in exhaled breath condensate [ Time Frame: baseline and after at 16, 52, 104 weeks of omalizumab treament ]
    periostin, IL-6
  • Change in selected biomarkers in peripheral blood [ Time Frame: baseline and after at 16, 52, 104 weeks of omalizumab treament ]
    eosinophil count
Same as current
Lung function tests [ Time Frame: baseline and after at 16, 52, 104, 156 weeks of treament ]
FEV1, FVC, FEV1/FVC
Same as current
 
BIOmarkers in Severe AsthMa Patients on Omalizumab Treatment
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample
Severe allergic asthma
Severe Asthma
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Same as current
December 30, 2018
November 5, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact: Joanna Hermanowicz-Salamon, MD, PhD + 48 225992599 jhermanowiczsalamon@gmail.com
Contact: Rafał Krenke, MD, PhD, Prof +48 225992562
Poland
 
 
NCT03361111
Dep. of Pneum. and Allerg.
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Joanna Hermanowicz-Salamon, Medical University of Warsaw
Medical University of Warsaw
Not Provided
Principal Investigator: Joanna Hermanowicz-Salamon, MD,PhD Department of Internal Medicine, Pulmonary Diseases and Allergy Medical University of Warsaw, Poland
Medical University of Warsaw
October 2018