Efficacy and safety of QGE031 versus placebo and Omalizumab in patients aged 18-75 years with asthma
- Conditions
- asthmaMedDRA version: 14.1Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 14.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2012-002298-69-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 457
Patients eligible for inclusion in this study have to fulfill all of the following criteria: For all patients (treatment arms A to G): 1. Signed written informed consent before any assessment is performed, including any adjustments to asthma medication at Visit 1. 2. Male and female adult patients aged = 18 -=75 years. 3. Patients with a diagnosis of asthma (according to GINA 2011 guidelines) for a period of at least 24 months prior to Visit 1. 4. A documented history of two asthma exacerbation(s) in the previous 24 months (with one episode occurring within the last 12 months). Both episodes of asthma exacerbation must have documented treatment with systemic corticosteroids for at least 3 days. 5. FEV1 of = 40% and = 80% of the predicted normal value for the patient, after withholding bronchodilators1. 6. Patients must demonstrate an increase in FEV1 of =12% and 200 mLs within 30 minutes after administration of 400 µg salbutamol/albuterol (or equivalent dose) prior to randomization2. • All patients must perform a reversibility test at Visit 101 If reversibility is not demonstrated at Visit 101: • Patients may be permitted to enter the study with historical evidence of reversibility that was performed according to ATS/ERS guidelines within the 12 months prior to Visit 12. If reversibility is not demonstrated at Visit 101 and historical evidence of reversibility is not available (or was not performed according to ATS/ERS guidelines): • The reversibility test may be repeated on one occasion at an unscheduled visit prior to randomization. 7. Body mass index (BMI) must be within the range of 18 to 35 kg/m2 inclusive. 8. Daily treatment with: • At Visit 1: Medium or high dose3 ICS plus a LABA (b.i.d.) for = 3 months prior to Visit 1*, and • At Visit 201: High dose ICS3 plus a LABA (b.i.d.) that has been stable for at least 4 weeks prior to Visit 201. See Appendix 3 for definitions of Medium” and High” dose ICS (per GINA 2011) *Patients receiving medium dose ICS at Visit 1 should be up-titrated to high dose ICS at Visit 101; this dose should then remain stable during the 4 week run-in epoch prior to Visit 201. 9. Asthma which is not adequately controlled on current treatment, as demonstrated by an Asthma Control Questionnaire (ACQ) score of = 1.5 (Juniper et al, 2006) and prior to randomization. 10. Patients should be allergic or atopic to a perennial aeroallergen (house dust mite [dermatophagoides pteronyssinus, dermatophagoides farina], cockroach, mold, cat/dog/animal dander), as diagnosed at Visit 101, prior to entry into the study, by either a skin prick test (= 3mm diameter above background) or a positive in-vitro specific IgE (e.g. RAST/CAP) test. 11. Compliance with Electronic Peak Flow/ ediary device4 during the screening epoch (at the investigators judgment the run-in epoch can be extended to collect 14 days of acceptable ePEF/ediary data). 1 Withholding of bronchodilators prior to spirometry: short-acting ß2-agonist for = 6 hrs and long-acting beta2-agonist (or fixed dose combinations of LABA and ICS) for = 24 hours. 2 Where a patient is assessed as eligible based on historical evidence of reversibility, a copy of the original printed spirometry report with relevant spirometry tracings must be available as source documentation. 3 See Appendix 3 for GINA 2011 definition of medium and high dose ICS. 4 Compliance is defined as = 85% of the ePEF assessments or and = 85% of the morning o
Patients fulfilling any of the following criteria are not eligible for inclusion in this study. No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients. For all patients (treatment arms A to G): 1. Patients whose baseline serum IgE levels1 or body weight are outside the limits of the locally approved omalizumab dosing table. 1See Section 6.6.1.2 for definition of baseline serum IgE and refer to relevant locally approved omalizumab dosing table in the QGE031B2201 study manual. 2. Who have smoked or inhaled tobacco products within the 6 month period prior to Visit 1, or who have a smoking history of greater than 10 pack years (e.g.10 pack years = 1 pack /day x 10 yrs., or ½ pack/day x 20 yrs.). 3. Who have had an asthma attack/exacerbation requiring a short burst of systemic corticosteroids for at least 3 days within 6 weeks prior to Visit 1. 4. If patients experience an asthma attack/exacerbation requiring a short burst of systemic corticosteroids during screening and run-in they may be re screened 6 weeks after recovery from the exacerbation. 5. Who have had a respiratory tract infection or asthma worsening within 4 weeks prior to Visit 1. 6. If patients experience a respiratory tract infection or asthma worsening during screening and run-in they may be re screened 4 weeks after recovery from their respiratory tract infection. 7. Patients with a history of life-threatening asthma, including a history of significant hypercarbia (pCO2>45mmHg), prior intubation (endotracheal and NIPPV), respiratory arrest, or seizures as a result of asthma. 8. Patients with evidence upon visual inspection (laboratory culture is not required) of clinically significant oropharyngeal candidiasis during screening and run-in, with or without treatment. Patients may be re screened once their candidiasis has been treated and has resolved. 9. Patients with any chronic conditions affecting the upper respiratory tract (eg. chronic sinusitis) which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study. 10. Patients with a history of chronic lung diseases other than asthma, including (but not limited to) chronic obstructive pulmonary disease, bronchiectasis, sarcoidosis, interstitial lung disease, cystic fibrosis, and tuberculosis. 11. Patients with aspirin or other nonsteroidal anti-inflammatory drug related asthma. 12. Patients with elevated serum IgE levels for reasons other than atopic conditions (e.g., parasitic infections, hyperimmunoglobulin E syndrome, allergic bronchopulmonary aspergillosis). 13. Patients with uncontrolled diabetes Type I or uncontrolled diabetes Type II. 14. Patients who have a clinically significant laboratory abnormality at run-in, in the judgment of the investigator. 15. Patients who, either in the judgment of the investigator have a clinically significant condition such as (but not limited to) unstable ischemic heart disease, NYHA Class III/IV left ventricular failure arrhythmia, uncontrolled hypertension, cerebrovascular disease, neurodegenerative diseases, or other neurological disease, uncontrolled hypo- and hyperthyroidism and other autoimmune diseases, hypokalemia, hyperadrenergic state, or ophthalmologic disorder or patients with a medical condition that might compromise patient safety or compliance, interfere with evaluation, or p
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