severe persistent non-atopic asthma MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Trade Name: Xolair
Product Name: omalizumab
Product Code: IGE025
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: omalizumab
Concentration unit: mg/g milligram(s
Sponsors
Novartis Pharma S.A.S.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Outpatients who have been informed of the study procedures and medications and have given written informed consent prior to initiation of any study-related procedure. 2. Who are = 18 and = 70 years of age. 3. With a severe persistent asthma with the following characteristics: i. FEV1 1,000 µg beclometasone dipropionate equivalent per day) (cf. Appendix 2) plus inhaled long-acting ß2 agonist (with or without maintenance oral corticosteroid). iv. Non-atopic as defined by the EGEA Cooperative Group, i.e. negative blood multiallergic testing (ImmunoCAP® Phadiatop) and negative skin prick tests to a battery of common aeroallergens [dust mites (Dermatophagoides pteronyssinus, Dermatophagoides farinae), cat and dog dander, cockroaches (Blatella germanica), molds (Alternaria, Cladosporium, Aspergillus), and pollens of ragweed, birch tree, olive tree, timothy grass and Parietaria], demonstrated at Visit 1. Prick tests are considered negative if 15-20 minutes after allergen injection the mean diameter of wheal is =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Current smokers or smoking history stopped for less than 3 years or > 10 pack years. 2. Patients who have been treated for an asthma exacerbation during the 4 weeks prior to randomization. 3. Patients with an active lung disease other than non-atopic asthma (e.g.: allergic bronchopulmonary aspergillosis, COPD). 4. Patients with an active cancer, a suspicion of cancer or any history of cancer with less than 5 disease free years. 5. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL). 6. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: at least 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or at least 6 weeks post surgical bilateral oophorectomy with or without hysterectomy or hysterectomy OR are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). 7. Patients who are receiving methotrexate, gold salts, cyclosporine, anti-TNF therapy or troleandomycin within 3 months of Visit 1 or anticipate their use during the study. 8. Patients treated with omalizumab (currently or in the past). 9. Patients with aspirin or non steroidal anti-inflammatory drug (NSAID) related asthma diagnosed from the patients history. Patients can be included if use of aspirin or NSAIDs will be avoided for the entire duration of the study. 10. Patients who have been treated with investigational drugs over the past 30 days or within 5 half-lives of the investigational drug prior to Visit 2, whichever comes first. 11. Patients who are considered potentially unreliable or where it is envisaged the patient may not consistently attend scheduled study visits. 12. Patients with any other condition or prior/current treatment, which in the opinion of the investigator renders the patient ineligible for the study schedule.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To study the change from baseline in the expression of FceRI receptors of blood basophils and dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo.;Secondary Objective: Efficacy : • To study the change in fractional exhaled nitric oxide (FeNO) after 4, 8, 12 and 16 weeks of treatment with omalizumab as compared with placebo (using the Niox Mino® device). • To study the change from baseline in induced sputum eosinophil count after 16 weeks of treatment with omalizumab as compared with placebo (in a subset of patients in selected centers). Safety : • To assess safety of omalizumab with regard to adverse events and weight. See other objectives in the protocol page 12-13. ;Primary end point(s): To study the change from baseline in the expression of FceRI receptors of blood basophils and dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo. | — |
Countries
France
Outcome results
None listed