A prospective, multicenter, double-blind, placebo-controlled randomized study to assess efficacy and safety of LAIS® Grass pollen tablets in patients with seasonal grass pollen-induced allergic rhinoconjunctivitis - LAIS® Grass pollen tablets in seasonal grass pollen-induced allergic rhinoconjunctivitis

OFARMA S.P.A.0 sites264 target enrollmentJuly 8, 2020

Conditionsseasonal grass pollen-induced allergic rhinoconjunctivitis MedDRA version: 20.0Level: LLTClassification code 10036019Term: Pollen allergySystem Organ Class: 100000004870 MedDRA version: 20.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853 Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

DrugsAERIUS - 5 MG 20 COMPRESSE RIVESTITE CON FILM USO ORALE NASONEX - SPRAY NASALE 0.05% 140 EROGAZIONI 50 MCG/SPRUZZO BF2 - 5 MG COMPRESSE 20 COMPRESSE LEVOSTAB - 0.5 MG/ML SPRAY NASALE, SOSPENSIONE FLACONE 10 ML

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: seasonal grass pollen-induced allergic rhinoconjunctivitis
Sponsor: OFARMA S.P.A.
Enrollment: 264
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 8, 2020

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

OFARMA S.P.A.

Eligibility Criteria

Inclusion Criteria

•1\.Female (not breastfeeding, with negative urine pregnancy test and using either a highly effective method of contraception during the entire study or being post\-menopausal for at least 1 year or sterilized women) or male patients, aged 12–64 years with a history of at least 2 years of grass pollen induced allergic rhinoconjunctivitis (ARC) with or without seasonal controlled allergic asthma \[From the Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2018\. Available from: http://www.ginasthma.org],;
•2\.Moderate/Severe (interfering with usual daily activities or sleep) ARC defined according to ‘Allergic Rhinitis and it impact on Asthma’ (ARIA) guidelines (Brozek et al., 2017\)
•a) Requiring treatment (either antihistamines or nasal corticosteroids) during the grass pollen season and
•b) Retrospective Symptoms Score \>10 out of pharmacotherapy or \>4 under pharmacotherapy, as sum of the score (0\-3\) for each of the six nasal and conjunctival symptoms referred to the previous grass pollen season (range 0\-18\) (EMA/414476/2011\);
•3\.Positive clinical history of grass pollen allergy, proven by:
•The majority of clinical symptoms appearing during the grass pollen season;
•Specific IgE reactivity (immuneCAP) \>\= Class 2 to major allergens of Phleum pratense (if specific IgE have been recently examined in the year 2019 before the inclusion in the study, for instance at the moment of first clinical diagnosis, the results can be used as screening data);
•Positive Skin Prick Test to Phleum pratense (or Grass mix extract including Phleum pratense) (wheal diameter \>\= 3 mm, negative control \< 2 mm);
•Positive reaction to Titrated Nasal Provocation Test (TNPT) with Lebel’s symptoms score (LSS) \>\=6;
•Wash\-out of pharmacological treatment interfering with the test is required prior to the SPT/TNPT (see dedicated section).

Exclusion Criteria

•Clinically relevant hypersensitivity to any of the excipients used in LAIS® Grass sublingual tablets or in placebo tablets (lactose monohydrate, cellulose microcrystalline, silica colloidal anhydrous and magnesium stearate);
•History of intolerance to the rescue medications (prednisone, desloratadine, mometasone, levocabastine) and solution for nasal test, or their excipients; conditions representing contraindications to the rescue medications;
•Previous immunotherapy with grass allergens or cross\-reacting allergens within the last 5 years;
•Ongoing immunotherapy with any allergen;
•Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection;
•History of moderate to severe perennial allergic rhinitis requiring medication, caused by perennial allergen (i.e. house dust mites);
•History of clinically relevant allergic rhinitis and/or asthma caused by an allergen to which the subject is regularly exposed (i.e. pets’ and horse hair or dander);
•History of clinically relevant seasonal allergic rhinitis and/or asthma due to genuine sensitization to tree pollens (Oleaceae, Betulaceae Corylaceae Cupressaceae), main weed pollens (Urticacee), Chloridoideae grass pollen (Cynodon Dactylon), moulds (Alternaria),with diffusion adjacent to the start of and potentially overlapping the grass pollen season (each co\-sensitization has to be evaluated for relevance with relation to the expected exposure in each geographic area and climatic zone; for example, a subject with positive skin test to Parietaria, history of symptoms clinically related to Parietaria exposure in a region with expected significant levels of Parietaria pollens has to be excluded);
•Symptoms of or treatment for acute inflammation of the nose, upper respiratory tract infection, acute sinusitis, acute otitis media, or other relevant infectious process within 14 days of the baseline TNPT visit;
•Diagnosed of choanal atresia, nasal polyps, septal perforation, severe septal deviation, atrophic rhinitis, adenoids obstructing nasal ventilation;