Asthma
Conditions
Interventions
Trade Name:
Xolair Powder and Solvent for Injection
Pharmaceutical Form:
Sponsors
University College Dublin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to identify the genes/gene networks that are activated during acute asthma exacerbations and to identify those genes/gene networks that are attenuated by a short course of treatment with omalizumab initiated at the time of presentation with acute symptoms;Secondary Objective: The secondary objectives would be to investigate the effect of omalizumab on the recovery of lung function as captured by FEV1 and other related measures of pulmonary function following an acute asthma exacerbation ;Primary end point(s): The primary endpoint is characterization of the gene expression signature triggered in myeloid cells during acute asthma exacerbations and identification of associated genes/gene networks that are sensitive to omalizumab administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoint is the time taken to restoration of individual patients’ airway responsiveness to a stable value as measured by a bronchial challenge with Mannitol following acute severe asthma exacerbation, in patients given 2 doses of omalizumab during the exacerbation. Airway responsiveness stability will be deemed to have been achieved when an individual patient returns successive PC15 readings during follow-up which are not significantly different (i.e. = 10% variability between successive PC15 readings). | — |
Countries
Ireland
Outcome results
None listed