A Multi-Center, Randomized, Double Blind, Placebo-Controlled, ‘add-on’ study to investigate the efficacy and safety of 24 weeks intravenous treatment with QAX576 in patients (=18-75 years) with persistent asthma not adequately controlled with inhaled corticosteroids and long acting ß2-agonists

Phase 1

• Conditions: persistent moderate to severe asthma patients not adequately controlled with inhaled corticosteroids and long acting ß2-agonists; MedDRA version: 13.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

• Registration Number: EUCTR2009-011590-32-BE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-18
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

1. Signed written informed consent before any assessment is performed, including any adjustments to asthma medication prior to Visit 2.
2. Male and female adult patients aged = 18 -75 years.
3. Female patients must be:
a. surgically sterilized at least 6 months prior to study participation (documentation of
sterilization must be provided) or
b. postmenopausal (no regular bleeding for at least 1 year), postmenopausal status must be confirmed by plasma FSH level of > 40IU/L at Visit 2
Note: A pregnancy test will be done on all female subjects regardless of reported
reproductive status at specified time points throughout the study.
5. Body mass index (BMI) must be within the range of 18 to 39 inclusive. For tables see Appendix 3.
6. Asthma, = 1 years duration diagnosed according to GINA guidelines (National Institute of Health, National Heart, Lung and Blood Institute, 2007)
7. Daily treatment with > 500µg BDP (>250µg b.i.d.), or equivalent, plus a LABA (b.i.d) (GINA step 4/5 therapy) for = 3 months prior to Visit 2, that has been stable for at least 4 weeks prior to Visit 2.
8. Asthma which is not adequately controlled on current treatment, as demonstrated by an Asthma Control Questionnaire (ACQ) score of > 1.5 at the end of the screening period (Juniper et al, 2006).
9. FEV1 of = 40% and = 80% of the predicted normal value for the patient, after withholding bronchodilators 1.
• To be included in the induced sputum sub study patients must have an FEV1= 55%
predicted at Visits 2 and 3.
10. Patients with demonstrated or documented increase of = 12% in FEV1 over their baseline value within 30 minutes of inhaling up to 400/360 µg of salbutamol / albuterol via an MDI after withholding bronchodilators 1,2 (the reversibility test).
11. Compliance with Electronic Peak Flow/ ediary device during the screening period* (at the investigators judgment the screening period can be extended to collect 14 days of acceptable ePEF/ediary data)
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Who have smoked or inhaled tobacco products within the 6 month period prior to Visit 2, or who have a smoking history of greater than 10 pack years, (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked).
2. Diagnosed with COPD as defined by the GOLD guidelines (Global Initiative for Chronic Obstructive Lung Disease 2008).
3. Who have had an asthma attack/exacerbation requiring a change in maintenance ICS or OCS treatment, or a short burst of systemic corticosteroids, within 6 weeks prior to Visit 2.
4. Who have had a respiratory tract infection within 6 weeks prior to Visit 2.
5. Who have a medical history (within the 3 months prior to Visit 1) that might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study.
6. With a history or current treatment for hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or an AST/ALT or INR of more than 1.5x ULN at Visit 2.
7. With history of renal disease or creatinine level above the ULN at Visit 2.
8. With fasting triglycerides over 300 mg/dl (3.39 mmol/L) at Visit 2.
9. With active cancer or a history of cancer with less than 5 years disease free survival time (whether or not there is evidence of local recurrence or metastases). Localized basal cell carcinoma (without metastases) of the skin is acceptable.
10. With a history of schistosomiasis, or stool examination positive for ova or parasites (at Visit 2), or travel to an area endemic with schistosomiasis (in the 6 months prior to Visit 2), including but not limited to Southeast and Southwest Asia, South America and Africa. Travel to these areas must not be planned until at least 6 months after the last dose.
11. With a history of immunodeficiency diseases or hepatitis B or C.
12. With a history of hypersensitivity to any ingredients of the study drugs, or drugs related to QAX576 (e.g. monoclonal antibodies, polyclonal gamma globulin, polysorbates).
13. Who have had live attenuated vaccinations within 30 days prior to screening visit 2 or during the screening period1.
14. Treatments for asthma and allied conditions: the following medications must not be used prior to Visit 2 for at least the minimum washout period specified below or at any time during the study: • Omalizumab or other monoclonal antibody treatment within 4 months prior to Visit 2 • Methotrexate, gold salts, cyclosporin, troleandomycin: 3 months of Visit 2. • Short acting anti-cholinergics within 8 hours prior to Visit 2 • Long acting anti-cholinergics within 7 days prior to Visit 2.
15. Maintenance Immunotherapy (desensitization) for allergies is allowed if maintenance dose has been administered for at least 3 months prior to Visit 2, and is expected to remain unchanged throughout the course of the study.
16. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 halflives prior to Visit 2, whichever is longer.
17. Patients that take acetaminophen (paracetamol) chronically, i.e. more than 1 g/day for more than 3 out of 7 days, or more than 2 g/ day for more than 1 day out of 7 days.
18. With a known history of non-compliance to medication or who are unable or unwilling to use Electronic Peak Flow with ediary device or perform spirometry measurements.
19. Patients that do not maintain regular day/night, waking/sleeping cycles (e.g. night shift workers will be excluded).
20. Patients with a h

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified