A Study which Aims at Finding an Optimal Dose and at Evaluating the Efficacy of LAIS Mite Sublingual tablets in Patients Suffering from with Mite-Induced Allergic Rhino-Conjunctivitis Without or With Controlled Asthma in an Allergen Exposure Chamber (AEC).
- Conditions
- Patients Suffering from Mite-Induced Allergic Rhino-Conjunctivitis Without or With Controlled AsthmaMedDRA version: 19.1Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2016-003439-39-DE
- Lead Sponsor
- ofarma S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
1.Male or female (not breastfeeding, with negative pregnancy test and using either a highly effec-tive method of contraception during the entire study (implant, intrauterine device, male/female sterilization, hormonal contraception, sexual abstinence) or being post-menopausal for at least 1 year or sterilized women) outpatients, 18–64 years old (please also refer to section XI.3.).
2.Moderate to severe mite-induced rhino-conjunctivitis of at least 2 year according to the ARIA guidelines (please see the definition of moderate to severe rhino-conjunctivitis in the section III.2. Classification of Allergic Rhinitis).
3.Positive specific SPT (wheal diameter of 3 mm or larger than saline control) at screening for both mite extracts (Der p., and Der f.).
4.Written informed consent.
5.Positive nasal provocation test at screening (PNIF reduction by = 20% and symptom score increase by = 2 score points or PNIF reduction by = 40%).
6.Minimum level of rhinitis symptoms in a mite exposure challenge (baseline TNSS < 3 score points) and increase of a TNSS of = 4 score points from baseline (out of 12) within 60–90 min period during exposure at the first AEC visit.
7.Subject must be willing and able to comply with the trial protocol.
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 184
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Allergen-specific immunotherapy (AIT) within the previous five years with mite-extracts and any current immunotherapy with another allergen.
2.History of hypersensitivity to any of the excipients used in LAIS® mites sublingual tablets or in placebo tablets (lactose monohydrate, cellulose microcrystalline, silica colloidal anhydrous and magnesium stearate).
3.Clinically relevant co-sensitization(s) (moderate-severe symptoms of AR/Asthma), e.g. to seasonal pollen or any animal hair and dander if regularly exposed and/or as demonstrated in SPT.
4.Asthma requiring treatment other than short-acting inhaled ß2-agonists and low-dose inhaled corticosteroids (e.g. Step 2 (patients receiving Leucotriene receptor antagonists (LTRA)) to Step 5, GINA-definition 2015) at screening and/or severe asthma or history of uncontrolled/partly controlled asthma within 3 months prior to screening.
5.Subjects with reduced lung function forced expiratory volume in 1 second (FEV1) < 80% of the predicted value at screening.
6.Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media, active tuberculosis or other relevant infectious process within 14 days of the first baseline AEC visit.
7.Clinically relevant nasal polyps, history of surgery either of paranasal sinus or of nasal turbinates and/or elective maxillofacial surgery within 6 months after planned treatment start (randomization).
8.History of anaphylaxis with cardiorespiratory symptoms (immunotherapy, exercise-induced, food allergy, drugs or an idiopathic reaction).
9.History of recurrent (defined as at least 2 or more episodes) generalized urticaria during the last 2 years.
10.History of drug-induced (including immunotherapy) facial and/or neck angioedema or a family (parents and siblings) history of hereditary angioedema.
11.Any clinically relevant chronic disease of = 6 months duration (e.g. cystic fibrosis, emphysema, malignancy, malabsorption or malnutrition, renal or hepatic abnormality, chronic infections or any other diseases that in the opinion of the investigator would interfere with the trial evaluations or the safety of the subjects).
12.Systemic disease affecting the immune system (e.g., insulin-dependent diabetes, severe active autoimmune disease, immune complex disease or immune deficiency disease).
13.Contraindications to adrenaline (e.g. heart rhythm disorders, hyperthyroidism, Parkinson symptoms, glaucoma).
14.Concurrent use of prohibited medication(s) or inadequate wash-out of medication prior to SPT/NPT and AEC exposition. Other medications will be permitted, if they are not expected to interfere with the ability of the patient to participate in the study and provided they have been on a stable regimen (i.e., the same daily dosage and route of administration) for 4 weeks prior to screening.
15.Immunosuppressive treatment (ATC code L04 or L01) within 3 months prior to the screening visit.
16.Treatment with antidepressant medication with antihistaminic effect (e.g. doxepin, mianserin)
17.Treatment with antipsychotic medications with antihistaminic effect (e.g. chlorpromazine, levomepromazine, clozapine, olanzapine, thioridazine).
18.Treatment with anti-IgE drugs (e.g. omalizumab) within 130 days / 5 half-lives (whichever is the longest before 1st dosing).
19.Treatment with systemic ß-blockers.
20.Use of an investigational drug within 30 days / 5 half-lives of the drug (whichever is the longest prior to screening).
21.Direct family members of th
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