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Severe AsthmaBIOSAMOTNCT03361111

BIOmarkers in Severe AsthMa Patients on Omalizumab Treatment

An observational study of Severe Asthma, run by Medical University of Warsaw at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Severe Asthma
How many people
16 participants
Where
1 sitePoland
Study dates
4 Apr 2013to 30 Dec 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Severe allergic asthma

Who may be able to join

  • 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).

Who cannot join

  • smoking
  • pregnancy

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Joanna Hermanowicz-Salamon

    Warsaw, 00-707

Other trials in Poland

About this study

Official title: 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.

Read the 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.

Conditions
Severe Asthma
Keywords
severe asthma, anti-IgE, periostin, induced sputum,, exhaled breath condensate
Medical subject headings
Asthma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in selected biomarkers in induced sputum

    eosinophil count

    Measured: baseline and after 156 weeks of omalizumab treament

  2. Change in selected biomarkers in peripheral blood

    eosinophil count

    Measured: baseline and after 156 weeks of omalizumab treament

  3. Change in selected biomarkers in induced sputum

    periostin

    Measured: baseline and after 156 weeks of omalizumab treament

  4. Change in selected biomarkers in exhaled breath condensate

    periostin

    Measured: baseline and after 156 weeks of omalizumab treament

  5. Change in selected biomarkers in induced sputum

    IL-6

    Measured: baseline and after 156 weeks of omalizumab treament

  6. Change in selected biomarkers in exhaled breath condensate

    IL-6

    Measured: baseline and after 156 weeks of omalizumab treament

Secondary outcomes (3)

  1. Change in selected biomarkers in induced sputum

    eosinophils, periostin, IL-6

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

  2. Change in selected biomarkers in exhaled breath condensate

    periostin, IL-6

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

  3. Change in selected biomarkers in peripheral blood

    eosinophil count

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2017
  2. Study start4 Apr 2013
  3. Primary completion5 Nov 2018
  4. Study completion30 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03361111
Sponsor's protocol ID
Dep. of Pneum. and Allerg.
Acronym
BIOSAMOT
Status last verified
Oct 2019
First submitted
12 Nov 2017
Last updated
11 Oct 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20688929

  • 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.

    PubMed 23471469

  • 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.

    PubMed 11549526

  • 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.

    PubMed 12480423

  • 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.

    PubMed 22857879

Questions about this trial

What is this clinical trial studying?

An observational study of Severe Asthma, run by Medical University of Warsaw at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in selected biomarkers in induced sputum (time frame: baseline and after 156 weeks of omalizumab treament). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03361111, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2019.

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