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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

Tracking Information
First Submitted Date November 12, 2017
First Posted Date December 4, 2017
Last Update Posted Date October 5, 2018
Actual Study Start Date April 4, 2013
Estimated Primary Completion Date November 5, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 27, 2017)
  • 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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03361111 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 27, 2017)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 27, 2017)
Lung function tests [ Time Frame: baseline and after at 16, 52, 104, 156 weeks of treament ]
FEV1, FVC, FEV1/FVC
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title BIOmarkers in Severe AsthMa Patients on Omalizumab Treatment
Official Title Utility of Biomarkers in Evaluating Responsiveness to Anti-IgE (Omalizumab) in Severe Asthma Patients
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Severe allergic asthma
Condition Severe Asthma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 27, 2017)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 30, 2018
Estimated Primary Completion Date November 5, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Joanna Hermanowicz-Salamon, MD, PhD + 48 225992599 jhermanowiczsalamon@gmail.com
Contact: Rafał Krenke, MD, PhD, Prof +48 225992562
Listed Location Countries Poland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03361111
Other Study ID Numbers Dep. of Pneum. and Allerg.
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Joanna Hermanowicz-Salamon, Medical University of Warsaw
Study Sponsor Medical University of Warsaw
Collaborators Not Provided
Investigators
Principal Investigator: Joanna Hermanowicz-Salamon, MD,PhD Department of Internal Medicine, Pulmonary Diseases and Allergy Medical University of Warsaw, Poland
PRS Account Medical University of Warsaw
Verification Date October 2018