Asthma
Conditions
Interventions
Trade Name: Xolair 150 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
Product Name: Omalizumab
Product Code: IGE025
Pharmaceutical Form: Powder for solution for injection
INN or Pr
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female (post menopausal or surgically sterilized or using approved barrier or hormonal contraception) patients with intermittent, mild persistent or moderate persistent, aged 18-65 years. Diagnosis with asthma with FEV1 of = 65% (pre-bronchodilator) of the predicted value for height, race, age, and sex. Asthma exacerbation-free for = 4 weeks Otherwise healthy patients except for diagnoses related to allergy or asthma Body weight between 40 and 150 kg 24 subjects in Group 1 will have IgE levels between 30 IU/mL and 300 IU/mL; 24 subjects in Group 2 will have IgE levels between 700 IU/mL and 2000 IU/mL; 10 patients in Group 3 will have IgE levels between 301 IU/mL and 699 IU/mL and bodyweight = 150 kg. Patients must have well-characterized positive skin reactivity to a specific allergen within 2 years prior to screening (this allergen will be used for bronchoprovocation testing). Patients must also demonstrate a PD20 response to methacholine in the inhaled bronchoprovocation test prior to participating in allergen bronchoprovocation testing (ABP) Patients must demonstrate a PD20 response to an aeroallergen in the graded ABP at screening. Be able to provide written informed consent 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Current active smokers with =5 pack-year smoking history Asthma exacerbation requiring treatment with oral or IV corticosteroids in the past 3 months Medical conditions that may interfere with the performance of spirometry or may pose a potential hazard from performing spirometry. Any other medical condition that in the opinion of the investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from being in the study. History of asthma attack requiring a visit to an emergency room in the 6 weeks before or during Screening History of asthma attack requiring treatment with intubation and mechanical ventilation in the 12 months before Day 1 History of clinically significant drug allergy. A known hypersensitivity to the study drug or drugs similar to the study drug. History of immunocompromise, including a positive HIV (ELISA and Western blot) test result. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result. History of intolerance to methacholine or allergen bronchoprovocation Elevated IgE due to suspected parasitosis History of bleeding disorders; prior serious bleeding, low platelet counts, anticoagulant Allergen Immunotherapy may not be started during this study. It is permitted to continue ongoing allergen immunotherapy at stable doses during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint supporting this objective will be the change in the early-phase allergic response in omalizumab treated groups in comparison to placebo. The secondary endpoint supporting this objective will be the change in the late-phase allergic response in omalizumab treated groups in comparison to placebo.;Main Objective: To demonstrate that two groups of allergic asthmatic patients with lower and higher IgE, defined by serum IgE of 30-300 IU/mL (Group 1- standard IgE group) and 700-2000 IU/mL (Group 2-high IgE group) can be similarly protected from allergen-induced bronchoconstriction by omalizumab. The primary endpoint supporting this objective will be the change in the early-phase allergic response in omalizumab treated groups in comparison to placebo. The secondary endpoint supporting this objective will be the change in the late-phase allergic response in omalizumab treated groups in comparison to placebo;Secondary Objective: Explore if the impact of Omalizumab on specific IgE (derived from the relationship of baseline and free IgE after Omalizumab administration) correlates with the observed effects on reducing airways response to allergen challenge. In those patients demonstrating a late phase response at baseline, inhibition of the late phase response will be analyzed. | — |
Countries
Germany, Netherlands
Outcome results
None listed