Difficult to control severe asthma
Conditions
Interventions
Trade Name: Xolair
Product Name: Xolair
Product Code: IGE025
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: OMALIZUMAB
CAS Number: 242138-07-4
Concentration un
Sponsors
Novartis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria •Male and female between 6 and 55 years old. If female, patient of childbearing potential must use a safe and efficacious birth control method. •Asthma is considered as not well-controlled if patient has 3 or more of the following conditions: a.Persistent day symptoms with current therapy twice at week or more, (siblings, dyspnea, cough, chest pain, thoracic oppression). b.One or more night-time awakenings over the last 4 weeks. c.Any limitation of age-appropriated habitual activities. d.Need of rescue medication (short acting ß2 agonist) for two or more occasions per week during the last 4 weeks before screening and 2 consecutives weeks within the 4 weeks before selection. e.PEF or VEF1 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria •Pregnant or lactating female or without safe and efficacious birth control method if of childbearing potential. •Currently smokers or history of smoking 10 or more packs per year. •Ex-smokers with a history of more than 10 years of smoking. As an exception, a patient with this criterion will be considered as eligible if the FEV1 reversibility of the first spirometry reaches 12%. •Active lung disease other than asthma. •Use of methotrexate, gold salts, troleandomycin, cyclosporine, immunosuppressants, gammaglobulin or any other type of monoclonal antibody used during the 6 months prior to the initial visit. •Use of omalizumab during the 4 months prior to de screening visit. •History of renal disease, cardiovascular disease, metabolic disease, hematologic disease, gastrointestinal disease, as well as immunodeficiency or cerebrovascular disease currently under treatment but not-controlled. •History of hepatic, neurologic, oncologic or autoimmune disease. •Patient under suspicion of having cancer. •Patients with history of hypersensitivity to sucrose, histidine, polysorbate 20 as well as to monoclonal antibodies or gammaglobulin. •Hypersensitivity to omalizumab or its excipients. •Abnormal values of the blood chemistry laboratory tests, over 2 times the upper limit normal, that are considered clinically significant. •Underage patient or any patient under vulnerable conditions who does not live with their parents or legal guardian.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ·Number of clinically significant asthma exacerbations Clinically significant asthma exacerbation episode include: moderate or severe asthma episodes that require evaluation and treatment at a medical office or urgent care or emergency room. ·Number of hospital admissions due to asthma exacerbation. Number of days of concomitant medications use reported by participants at all visits via diaries. · The ACQ has six questions to be answered by the patient, each with a 7 point scale (0-good control, 6-poor control), and one question where the actual pre-bronchodilator FEV1 value expressed in % of predicted FEV1 was classified to scores from 0 (> 95% of predicted) to 6 (< 50% of predicted). The overall score is the average of the 7 questions; a minimum overall score of 0 = good control of asthma whereas a maximum overall score of 6 = poor control of asthma. A negative change in score indicates improvement in symptoms. ) ;Primary end point(s): · Number of patients able to reduce the baseline budesonide/formoterol dosis [ Time Frame: baseline and up to 12 months ] Number of patients able to reduce the baseline budesonide/formoterol dosis upon Weekly or every 2 weeks dose of omalizumab and daily dose of budesonide/formoterol taken since the previous visit ;Timepoint(s) of evaluation of this end point: Baseline and up to 12 months;Main Objective: To assess efficacy and safety of omalizumab treatment during 12 months in order to reduce the use of inhaled corticosteroid (ICS) in pediatric and adult patients with severe IgE-mediated asthma inadequately controlled with high doses of corticosteroids.) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Number of clinically significant asthma exacerbations [ Time Frame: 12 months ] Clinically significant asthma exacerbation episode include: moderate or severe asthma episodes that require evaluation and treatment at a medical office or urgent care or emergency room. • Number of hospital admissions due to asthma exacerbation. [ Time Frame: 12 months ] A hospital admission is defined as admissions to hospital involving a stay of at least 24 hours. • Days missed in school/work due to asthma exacerbation episodes [ Time Frame: 12 months ] Patient/parent/legal guarding reported number of missed days of school or work at each study visit via diaries. • Use of oral/systemic corticosteroid for asthma exacerbation Treatment [ Time Frame: 12 months ] Number of days of concomitant medications use reported by participants at all visits via diaries.;Timepoint(s) of evaluation of this end point: Baseline and up to 12 months | — |
Countries
Mexico
Contacts
Public ContactClinical trial Information Desk
Novartis pharma AG
Outcome results
None listed