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.
- Conditions
- AsthmaTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2012-002106-48-IE
- Lead Sponsor
- niversity College Dublin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
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.
10.Subjects must be able to provide written informed consent and must sign an REC approved informed consent form prior to initiation of any study procedures.
11.40 subjects must have confirmed allergy and randomization will assign equal numbers of these to treatment/placebo arms (see 6.3 below).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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
10.Have demonstrated noncompliance with previous regimens
11.Have a recent history of abusing alcohol, or illicit drugs.
12.Have participated in a clinical study involving an investigational drug or device within four weeks before the Screening visit.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method