Patients with grass pollen-related allergic rhinitis/rhino-conjunctivitis (with well-controlled mild-to-moderate or without asthma) MedDRA version: 21.1 Level: LLT Classification code 10001723 Term: Allergic rhinitis System Organ Class: 100000004855 MedDRA version: 20.0 Level: LLT Classification code 10001726 Term: Allergic rhinitis due to pollen System Organ Class: 100000004870 MedDRA version: 20.0 Level: LLT Classification code 10001709 Term: Allergic conjunctivitis System Organ Class: 1000
Conditions
Interventions
Product Name: SULGEN Spray Phleum Pratense
Pharmaceutical Form: Sublingual spray, solution
Pharmaceutical form of the placebo: Sublingual spray, solution
Route of administration of the placebo: Sublin
Sponsors
ROXALL Medizin GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients who signed and dated the patients' informed consent form obtained prior to any study-specific examination. • Female or male patients between 18 and 65 years of age, at the time of signing the informed consent form • Patients with moderate-to-severe allergic rhinitis / rhino-conjunctivitis due to grass pollen for at least two years according to the Allergic Rhinitis and its Impact on Asthma (ARIA) guideline. • Patients with or without well-controlled mild-to-moderate asthma according to GINA guidelines (Global Initiative for Asthma, 2022). • Forced expiratory volume (FEV1) in one second > 70 % of predicted normal value (only for asthmatic patients) • Sensitization to Phleum pratense, verified by: a) positive skin prick test (wheal diameter = 3 mm and negative control =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Previous immunotherapy with grass pollen allergen extract according to the homologous group of grass pollen of the “Poaceae group”, as defined in Annex 1 in the Guideline on allergen products: production and quality issues (EMEA/CHMP/BWP/304831), within the last 5 years • Patients with co-sensitizations or co-allergies to any perennial or seasonal allergen , which interfere with the conduct of the study (e. g. with the tNPT), especially if the result in SPT for this allergen is higher than that for Phleum pratense • Patients with co-sensitizations to any pollen or mould with overlapping seasons but which are not cross-reactive with Phleum pratense and with specific IgE levels = class 2 CAP/PHADIA (unless the relevance can be excluded by component resolved diagnosis) • Simultaneous participation in other clinical trials • Simultaneous specific immunotherapy with other allergens • Participation in a clinical trial in the last three months before enrolment • Asthmatic patients with forced expiratory volume (FEV1) = 70 % of predicted normal value • Partly controlled or uncontrolled asthma according to GINA guideline (Global Initiative for Asthma, 2022) • Severe acute or chronic inflammatory or infectious diseases • Diseases of the immune system such as autoimmune and immune deficiencies (with exception to well controlled Hashimoto thyroiditis and type-1 diabetes mellitus) • Chronic or acute diseases of the heart, kidney or liver with severe impairment of their function • Hypersensitivity to excipients of the IMP • Any severe or unstable lung disease (e. g. active tuberculosis, cystic fibrosis, COPD) • Chronic or severe acute diseases of nose or eyes • Irreversible secondary disorders of the target organs (e. g. emphysema, bronchiectasis) • Therapy with immunoglobulins • Completed or ongoing treatment with anti-IgE-antibody • Malignancy within the previous 5 years • Alcohol, drug, or medication abuse within the past year and/or during the study • Use of non-allowed medication (see section 5.3.1) • Contraindications for SLIT (Pitsios et al., 2015) • Contraindications for SPT • Contraindication for NPT • Relationship or dependence with the sponsor and/or investigator • Legal incapacity • Patients who are jurisdictional or governmentally institutionalized • Serious systemic reactions to allergen-specific immunotherapy in the past • Active chronic urticaria • Active severe atopic eczema • Existing or intended pregnancy, lactation or inadequate contraceptive measures for woman with child-bearing potential or a positive pregnancy test at screening • Severe psychiatric, psychological, or neurological disorders; completed or ongoing longterm treatment with tranquilizers or psychoactive drugs (including tricyclic antidepressants) • Risk of non-compliance by the patient with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this trial is to establish the optimal dose of SULGEN® Spray Phleum pratense in terms of benefit-risk balance. To assess the efficacy of four different doses of SULGEN® Spray Phleum pratense compared between each other and placebo. The primary efficacy endpoint is defined as a percentage of patients with an increased dosing step needed to provoke a positive response in the titrated nasal provocation test (tNPT) post-treatment compared with pre-treatment (i. e. any improvement) in each of the five study groups. This is based on the change of the response to tNPT with incremental concentrations of an allergen extract of Phleum pratense from baseline to end of treatment.;Secondary Objective: To assess the efficacy of four different doses of SULGEN® Spray Phleum pratense compared between each other and placebo by the change in the number of dosing steps (pre-post difference) needed to provoke a positive response in the tNPT from baseline to end of treatment in each of the five study groups.;Primary end point(s): To assess the efficacy of four different doses of SULGEN® Spray Phleum pratense compared between each other and placebo. The primary efficacy endpoint is defined as a percentage of patients with an increased dosing step needed to provoke a positive response in the titrated nasal provocation test (tNPT) post-treatment compared with pre-treatment (i. e. any improvement) in each of the five study groups. This is based on the change of the response to tNPT with incremental concentrations of an allergen extract of Phleum pratense from baseline to end of treatment.;Timepoint(s) of evaluation of this end point: around 9 months after start of the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoint: To assess the efficacy of four different doses of SULGEN® Spray Phleum pratense compared between each other and to placebo by the change in the number of dosing steps (pre-post difference) needed to provoke a positive response in the tNPT from baseline to end of treatment in each of the five study groups. Secondary safety endpoint: To analyse the safety and tolerability of four different doses of SULGEN® Spray Phleum pratense compared between each other and to placebo by number of treatment-emergent adverse drug reactions and number of patients affected in each group. ;Timepoint(s) of evaluation of this end point: around 9 months after start of the trial | — |
Countries
Germany, Kazakhstan, Turkey, Ukraine
Contacts
Public ContactMedical Manager
ROXALL Medizin GmbH
Outcome results
None listed