Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Cytos Biotechnology AG
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Able and willing to provide written informed consent
Able and willing to complete all protocol requirements
Between 18 to 65 years of age
Presence of persistent asthma for at least 6 months according to GINA 2011 guidelines at step 3 or 4 of treatment who has been on stable controller therapy for at least 4 weeks, and symptoms are not sufficiently controlled with medium to high doses of inhaled corticosteroid (ICS) (\>250 to ≤1000 µg/day fluticasone or equivalent) in combination with or without long acting beta agonist (LABA), insufficient control will be based on asthma control questionnaire (ACQ) score ≥1.5 points. Use of stable doses of other controller therapies according to GINA steps 3 and 4 (leukotriene modifiers, sustained release theophylline) are also acceptable, but NOT treatment with anti immunoglobulin E (IgE) antibodies within the past 6 months
Stable but insufficiently controlled baseline conditions as documented by ACQ ≥1.5 at the screening and the baseline visits.
Positive skin prick test (SPT) or radioallergosorbent test (RAST) to at least 1 aero-allergen during the screening period
Forced expiratory volume in one second (FEV1)≥40 to ≤90% of predicted value
Reversibility of airway obstruction as demonstrated by:
* FEV1 improvement by \>12% , and
* By ≥200 mL after inhaled β2-agonist (400 µg salbutamol or equivalent). If a subject does not meet reversibility criteria at the screening visit, reversibility may be retested once prior to run-in as long as the test is performed at least 5 days prior to the beginning of the run-in phase
You may not be if
Failure to meet at least 80% compliance with completion of asthma symptoms and medication diaries at the baseline visit, after initial instruction at the screening visit and where necessary additional training at the 2-weeks run-in visit. . An additional maximum 2-weeks training period may be added in such patients.
Treatment or hospitalization for asthma exacerbation within past 2 months.
Current use or use of systemic corticosteroids within past 2 months.
Current smokers.
Ex-smokers with a smoking history of \>10 pack years (1 package per day for 10 years).
Pregnancy or female planning to become pregnant during the study period.
Ongoing or planned specific immunotherapy (SIT) during the whole study period or SIT completed within the last 3 years.
Treatment with IgE antibodies (Xolair®) within past 6 months.
Use of investigational unapproved drugs within 30 days or within 5 half-lives of the investigational drug, whichever is longer, or planned use during the whole study period.
Use of investigational biologics within the last 6 months.
Previous participation in a clinical study with a virus like particle (VLP) Qb-based vaccine.
Possible dependency of the patient on sponsor and/or investigator.
Women of child bearing potential
Clareo Health | CYT003-QbG10, a TLR9-agonist, for Treatment of Uncontrolled Moderate to Severe Allergic Asthma
