A study conducted without a control (placebo or other drug) with the aim to establish the maximum tolerated dose of IMP in patient with grass pollen allergic rhinoconjunctivitis
- Conditions
- Graminacee pollen induced allergic rhinoconjunctivitisMedDRA version: 20.0Level: LLTClassification code 10001738Term: AllergySystem Organ Class: 100000004870Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2018-004472-35-IT
- Lead Sponsor
- ofarma S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
•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 significant 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:
oA medical history of moderate to severe allergic rhinoconjunctivitis for grass pollen allergens for at least 2 years (definition of allergy severity according to ARIA (Bousquet et al., 2001))
oA positive skin prick test (SPT, wheal diameter =3 mm) to grass pollen allergens, positive control (histamine) wheal =3 mm, negative control (NaCl) wheal <2 mm
oSpecific IgE against grass pollen allergens =0.7 kU/L
•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 30
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 grass pollen allergens within the last 5 years
•Ongoing immunotherapy with grass 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
•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. birch, hazel, parietaria) 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
•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
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