A double-blind, placebo-controlled study with increasing doses of chemically modified tree pollen drops in patients suffering from allergicinflammation of the conjunctiva and rhinitis which are caused by tree pollen allergens.
- Conditions
- Treatment of tree pollen-induced allergic rhinoconjunctivitisTherapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]MedDRA version: 20.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853
- Registration Number
- EUCTR2017-003063-34-DE
- Lead Sponsor
- ofarma S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 48
•Signed and dated Informed Consent Form by a legally competent patient
•Female or male patients aged 18–64 years
•Being in good physical and mental health
•Confirmed normal renal and liver function (including non-clinically signifcant deviations as defined per laboratory ranges)
•For females: non-pregnant, non-lactating with adequate contraception or unable to bear children (e.g. tubal ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period))
•Having the diagnosis of allergy based on all the following criteria:
•A medical history of moderate to severe allergic rhinoconjunctivitis for birch pollen allergens for at least 2 years (definition of allergy severity according to ARIA (Bousquet et al., 2001))
•A positive skin prick test (SPT, wheal diameter =3 mm) to birch pollen allergens, positive control (histamine) wheal =3 mm, negative control (NaCl) wheal <2 mm
•Specific IgE against birch pollen allergens (Bet v1) =0.7 kU/L
•Positive response to conjunctival provocation test with at least a 1/10 dilution from a birch allergen provocation test stock solution
•Being treated with anti-allergic medication for at least 2 seasons prior to enrolment
•For asthmatic patients: confirmed diagnosis of controlled, intermittent asthma according to Global Initiative for Asthma (GINA) guidelines with the following treatment (step 1): asthma symptoms are rare, there is no night waking due to asthma, no exacerbations in the last year and normal FEV1, use of short acting beta2-agonists as reliever medication as-needed, without the use of controller medication). If pulmonary function is tested by Peak Expiratory Flow, the patient has to achieve a PEF value =80% of the patient’s reference value.
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 48
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion
•Previous immunotherapy with birch pollen allergens within the last 5 years
•Ongoing immunotherapy with birch pollen allergens or any other allergens
•Being in any relationship with or dependence on the Sponsor, CRO and/or Investigator
•Inability to understand instructions/study documents
•History of severe systemic reactions and/or anaphylaxis to food (e.g. peanut, seafood), Hymenoptera venom (e.g. bee, wasp stings), medication (e.g. penicillin), etc.
•History of hypersensitivity to the excipients of the investigational product or placebo
•Mild persistent to severe persistent asthma, partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2014)
•Chronic asthma or emphysema, i.e. FEV1 <80% of the patient’s reference value or PEF <80% of the patients´ individual optimal value
•Respiratory tract infection or exacerbation of asthma within 4 weeks before the screening
•Patients symptomatic to any seasonal inhaled allergens circulating during the study period (e.g.hazel) confirmed by medical history and SPT
•Patients symptomatic to any perennial inhaled allergens (e.g. cat, dog, mites), to which the patients are regularly exposed during the study period, confirmed by medical history and SPT
•Infections in the oral cavity with severe symptoms
•Moderate to severe oral allergy syndrome caused by tree pollen-food cross-reactivity
•Oral inflammation or wounds
•History of significant renal disease or chronic hepatic disease
•Malignant active disease (ongoing or within the five past years)
•Severe autoimmune disease
•Immune defects including immunosuppression, immunopathies
•Vaccination, use of systemic immunosuppressive medications (e.g. methotrexate or cyclosporine A) or a blood transfusion one month before screening
•General inflammatory, severe, acute or chronic inflammatory diseases
•Other chronic diseases such as severe congestive heart failure, cardiovascular insufficiency, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc.
•Intake of antidepressant drugs with potent antihistamine properties such as tricyclic antidepressants (e.g. doxepin, amitriptyline, desipramine, imipramine, etc.)
•Administration or planned administration of anti-IgE antibodies, mast cell stabilizers or anti-leukotriene agents
•Use of systemic beta-blockers
•Active tuberculosis
•Contraindication for the use of adrenaline (including hyperthyroidism)
•Contraindication for CPT (eye diseases except for anomalies of refraction, active allergic conjunctivitis, contact lenses, antiallergic therapy)
•Known positive serology to Human Immunodeficiency Virus-1/2, Hepatitis B Virus or Hepatitis C Virus
•Females who are pregnant, lactating, or of child-bearing potential and not using adequate contraceptives
•Use of corticosteroids (oral, topic or nasal) or anti-histaminic drugs before screening visit. Exception made for routine medication for asthma control in asthmatic patients
•Planned vaccination during the study (e.g. against flu, pneumococae, etc.)
•Clinically relevant laboratory values, i.e. grade =2 according to the FDA Guidance for Industry for preventive Vaccine Trials (FDA 2007)
•Patients, who the Investigator believes will not comply with the study protocol (patients with alcohol/drug abuse, history of serious psychiatric disorder, or who unwilling to give informed c
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