Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT03361111 |
Date of registration:
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12/11/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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BIOmarkers in Severe AsthMa Patients on Omalizumab Treatment
BIOSAMOT |
Scientific title:
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Utility of Biomarkers in Evaluating Responsiveness to Anti-IgE (Omalizumab) in Severe Asthma Patients |
Date of first enrolment:
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April 4, 2013 |
Target sample size:
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16 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03361111 |
Study type:
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Observational |
Study design:
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Phase:
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Countries of recruitment
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Poland
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Contacts
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Name:
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Joanna Hermanowicz-Salamon, MD,PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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Department of Internal Medicine, Pulmonary Diseases and Allergy Medical University of Warsaw, Poland |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Severe Asthma
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Primary Outcome(s)
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Change in selected biomarkers in induced sputum
[Time Frame: baseline and after 156 weeks of omalizumab treament]
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Change in selected biomarkers in exhaled breath condensate
[Time Frame: baseline and after 156 weeks of omalizumab treament]
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Change in selected biomarkers in peripheral blood
[Time Frame: baseline and after 156 weeks of omalizumab treament]
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Secondary Outcome(s)
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Change in selected biomarkers in induced sputum
[Time Frame: baseline and after at 16,52,104 weeks of omalizumab treament]
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Change in selected biomarkers in exhaled breath condensate
[Time Frame: baseline and after at 16, 52, 104 weeks of omalizumab treament]
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Change in selected biomarkers in peripheral blood
[Time Frame: baseline and after at 16, 52, 104 weeks of omalizumab treament]
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Secondary ID(s)
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Dep. of Pneum. and Allerg.
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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