Adult Patients with Persistent Allergic Asthma MedDRA version: 9.1 Level: LLT Classification code 10001705 Term: Allergic asthma
Conditions
Interventions
Product Name: 900 mcg QbG10
Pharmaceutical Form: Solution for injection
Current Sponsor code: QbG10
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 2-
Sponsors
Cytos Biotechnology AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Able and willing to provide written informed consent • Able and willing to complete all protocol requirements • 18 to 65 years of age • History of persistent asthma according to GINA 2007 guidelines whose symptoms requiring long-term treatment with ICS • Positive skin prick test to at least one aero-allergen and anamnestically confirmed to cause asthma symptoms. In case of doubt the allergic nature of the asthma must be confirmed by nasal provocation with the suspected allergen. • FEV1 >60% of predicted value • FEV1 improvement >=12% after inhaled beta2-agonist (400 µg salbutamol) at screening • Airway responsiveness to methacholine (PC20 30 U/mL and estradiol must be =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Use of oral corticosteroids within past 3 months • Hospitalization for asthma exacerbation within past 6 months • Uncontrolled asthma defined by ACQ =1.5 points at screening or prior to treatment phase • Intermittent or seasonal asthma not requiring ICS treatment • Regular use of long-acting beta2-agonists (LABA). All LABAs should be discontinued after informed consent and at least 48h prior to the screening procedure to ensure appropriate washout. • Smokers or quitters with a smoking history of >10 packyears (one package per day for 10 years) •Major surgery within 4 weeks prior to enrollment • Presence or history of relevant cardiovascular, renal, pulmonary, endocrine, autoimmune, dermatological (in particular psoriasis), neurological and psychiatric (in particular depression) and ocular disease (in particular keratitis) as judged by the investigator. For psoriasis, family history should also be clean. • Current diagnosis or history of malignancy; presence of suspicious lymphadenopathy or splenomegaly on physical examination • Confirmed or suspected current infection with HIV, HBV, or HCV • Presence of active infectious disease as judged by the investigator • History of recurrent invasive streptococcal or staphylococcal infections, or known interleukin-1 receptor-associated kinase 4 (IRAK 4) deficiency • Active autoimmune diseases • Pregnancy (based on positive urine test at screening visit) or lactation • Female planning to become pregnant during the study period • Blood donation or loss of > 400 mL within 8 weeks prior to inclusion • Vaccination planned during study treatment period • History of abuse of alcohol or other recreational drugs • Lactose intolerance • Any specific immunotherapy (SIT) planned during the whole study period or any former SIT within the last three years. • Treatment with anti-IgE antibodies within past 6 months • Use of any investigational drug within 30 days before enrolment, or planned use during the whole study period • Previous participation in a clinical trial with a Qb-based vaccine • Possible dependency of the patient on sponsor and/or investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this clinical Phase IIa trial is to assess the pharmacodynamic and clinical efficacy of QbG10 as disease modifying drug administered to patients with persistent allergic asthma. Furthermore, safety, tolerability and immunogenicity of QbG10 will be assessed.;Secondary Objective: ;Primary end point(s): Inflammatory parameters (NO in exhaled air;Eosinophils in peripheral blood) and Clinical parameters (Methacholine test; Asthma questionnaire; Daytime/nighttime symptoms; Morning PEF; Use of rescue medication; Tolerance of ICS dose reduction; Skin prick test) serve as endpoints. | — |
Countries
Germany
Outcome results
None listed