Graminacee pollen induced allergic rhinoconjunctivitis MedDRA version: 20.0 Level: LLT Classification code 10001738 Term: Allergy System Organ Class: 100000004870
Conditions
Interventions
Product Name: Lais® Graminacee
Pharmaceutical Form: Sublingual spray, solution
Sponsors
Lofarma S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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: o A 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)) o A positive skin prick test (SPT, wheal diameter =3 mm) to grass pollen allergens, positive control (histamine) wheal =3 mm, negative control (NaCl) wheal =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the safety and clinical tolerability of Lais® Graminacee sublingual drops in patients with grass pollen-induced allergic rhinoconjunctivitis.;Secondary Objective: Not applicable;Primary end point(s): Safety and clinical tolerability will be assessed by: • Solicited adverse events including local reactions at the administration site (oropharyngeal and gastrointestinal symptoms) and systemic allergic reactions after investigational medicinal product administration;Timepoint(s) of evaluation of this end point: 49 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety and clinical tolerability will also be assessed by: • Unsolicited adverse events • Proportion of patients who reached the maximum dose • Use of rescue medication during treatment phase • Physical examinations and vital signs • Laboratory tests (blood count, renal and liver function parameters) • Pulmonary function for asthmatic patients;Timepoint(s) of evaluation of this end point: 49 days | — |
Countries
Italy
Contacts
Public ContactCRO
CD Pharma Srl
Outcome results
None listed