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The University of Southampton
Southampton Clinical Trials Unit

SoMOSA

Title

Study of mechanisms of action of omalizumab in severe asthma 

Description

Xolair (omalizumab) is an approved therapy for severe atopic asthma. However, the mechanisms of action that underlie the benefits of Xolair are not well understood.

Evidence from a large ongoing project in severe asthma (U-BIOPRED) shows that two key metabolites of prostaglandin D2 (PGD2): tetranorPGDM and 2,3-dinor-11-β-PGF2α, are elevated in the urine of severe asthmatic patients, but are not elevated in those treated with Xolair.

The purpose of this study is to use the technology of the 'omics' platforms used in U-BIOPRED (proteomics, lipidomics and breathomics) to identify biomarkers which are modulated by Xolair treatment to advance the understanding of how Xolair effects its clinical benefit.

Objectives

Primary Objective: To improve understanding of the mechanisms of omalizumab by assessing the effect of 16 weeks treatment with omalizumab on urinary excretion of a key metabolite of prostaglandin 2 (PGD2), 2, 3-dinor-11-β-PGF2α and other biomarkers detected by ‘omics’ methods developed by U-BIOPRED.

Secondary Objective: To identify biomarkers which are predictive of a good clinical response, with the measurements of biomarkers being done after the first 16 weeks of treatment.

Exploratory Objective: Evaluate the value of using other clinical endpoints, either alone or in combination with measured biomarkers, to predict which participants treated with Xolair will benefit in terms of clinical improvement after 16 weeks of treatment and after 1 year of treatment.

Trial Design

An open label, prospective, multicentre study 

Trial Status

Closed to recruitment - In follow Up

Population

220 Patients aged 18 – 80 who have severe uncontrolled atopic asthma who have experienced two or more exacerbations in the last 12 months.

Patients who have any other active lung disease or prior treatment with Xolair or another biologic in last 4 months will NOT be eligible. Current smokers or any patient who has smoked in the past year will be ineligible but other ex-smokers will be eligible provided they meet the criteria set out in the protocol.

Trial Team:

Senior Trial Manager:

Zina Eminton (023 8120 8214) 

Trial Manager:

Tom Oliver (023 8120 5334)

Clinical Data Coordinator:

Alex Allen (023 8120 8007)

Contact information

Email: somosa@soton.ac.uk

Fax: 0844 7740 621

SAE Reporting: CTU@soton.ac.uk or 0844 7740 62111

Essential Trial Documents

SoMOSA - GP Letter v1 29-Jul-2015

SoMOSA - Poster Text v1 30-Jul-2015

SoMOSA - Participant Information Sheet v2 03-Mar-2016

SoMOSA - CRF's Workbook Complete v1 no enrollment

SoMOSA - eCRF Completion Training Manual v2 25-Apr-2016

SoMOSA - Informed Consent Form v2 01-Mar-2016

SoMOSA - InForm Data Entry Guidelines v6 - 15-Dec-2016

SoMOSA - Protocol v4.1 12-Jan-2018

SoMOSA - Study Reference Manual v4 25-Jan-2019

SoMOSA RAVE eCRF Completion Guidelines v1 22-May-2017

 

Investigator Site File

Section 2.1 - SoMOSA - Master Patient List v1 10-Sep-2015

Section 2.2 - SoMOSA Screening Log v4 28-Jun-2016

Section 2.3 - SoMOSA Participant Registration Log v2 29-Oct-2015

Section 2.3 - SoMOSA Patient Enrolment Form v3 22-Nov-2016

Section 3.1 - SoMOSA Delegation Log v1 09-Sep-2015

Section 3.3 - SoMOSA Training Log v1 02-Oct-2015

Section 4.2 - SoMOSA Eligibility Prompt Card v3 12-Dec-2016

Section 5.1 - SoMOSA Instructions for completion of Serious Adverse Event Reporting v1 02-Oct-2015

Section 5.1 - SoMOSA Non-CTIMP SAE Report Form v5 08-Feb-2018

Section 6.2 - SoMOSA Biological Samples Storage and Delivery Log v2 13-Dec-2018

Section 8.3 - SoMOSA -Lab Kit RE-Supply v5 31-Jul-2018

Section 13.1 - SoMOSA Visit Log v1 10-Sep-2015

Pharmacy

Section 5.3 - SoMOSA Xolair Accountability Log v1 30-Sep-2015

Section 5.4 - SoMOSA Xolair Dispensing Log v2 15-Oct-2015

Section 5.5 - SoMOSA Xolair Re-Supply v2 25-May-2016

Section 5.9 - SoMOSA Xolair Destruction Log v1 30-Sep-2015

Section 9.1 - SoMOSA Visit Log v1 10-Sep-2015

Diaries

SoMOSA - Rescue Medication Diary v1 04-Aug-2015

Questionnaires

SoMOSA - Asthma Control Test

SoMOSA - ACQ_AU2.0_Eng-GB Secure

SoMOSA - AQLQ(S)-SA_AU2.0_Eng-GB Secure

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