An Investigative Study to characterize gene expression patterns in myeloid cells that are triggered during acute asthma exacerbations, and to identify associated genes/gene networks that are Omalizumab sensitive.

niversity College Dublin0 sites20 target enrollmentMay 15, 2012

Overview

No summary available.

Registry

who.int

Start Date

May 15, 2012

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity College Dublin

•In order to be eligible, subjects must:
•1\.Have a current diagnosis of asthma
•2\.Have preexisting or currently documented atopy
•3\.Fulfil the definition in section 3\.2 for acute exacerbation at the time of enrolment
•4\.Have a FEV1 of less than 80% of predicted
•5\.Be aged between 18 and 75yrs. old, inclusive
•6\.Have a normal chest X\-ray and EKG
•7\.Have a normal DLCO (diffusion in the lung of carbon monoxide)
•8\.Have a negative urine pregnancy test (women of childbearing potential) at the Screening visit. Women who are surgically sterile or those who are post\-menopausal for at least two years are not considered to be of childbearing potential.
•9\.Women of childbearing potential must agree to use a reliable double barrier method of contraception until study completion and for at least four weeks following their final study visit. A reliable double barrier method of contraception is considered to be a combination of TWO of the following: birth control pills/ implants/ injections. Intrauterine devices, spermicide, diaphragms or condoms.

•Subjects who meet any of the following criteria are ineligible for participation in the study:
•1\.If onset of acute exacerbation has been \> 48 hours
•2\.If they have a total lung capacity (TLC) less than 80 % of predicted normal or a forced expiratory volume in one second (FEV1\) \> 80% of predicted normal at baseline
•3\.If there is evidence of pneumonia, COPD or congestive heart failure
•4\.Greater than 5 pack year history of smoking.
•5\.Have ever had omalizumab in the past.
•6\.Female subjects who are pregnant or breastfeeding
•7\.Presence of a serum ALT or AST greater than 2 times the upper limit of normal at any time during the Screening period
•8\.Have a contraindication to treatment with omalizumab.
•9\.Have a history of malignancy