Efficacy and safety of subcutaneous cluster immunotherapy with cluster-allergoid CLUSTOID® (glutaraldehyde-polymerized allergen extract of mixtures of grass and rye allergens – Holcus lanatus, Dactylis glomerata, Lolium perenne, Phleum pratense, Poa pratensis, Festuca elatior, Secale cereale) in patients with allergic rhinoconjunctivitis sensitized to grass and with or without rye pollen sensitization. A prospective, double-blind, randomized, placebo-controlled, multi-centre trial. - Specific Immunotherapy with CLUSTOID®: Efficacy and safety

Start Date30 Sep 2008

Sponsor / Collaborator

ROXALL Medizin GmbH

100 Clinical Results associated with Birch cluster immunotherapy(Inmunotek SL)

100 Translational Medicine associated with Birch cluster immunotherapy(Inmunotek SL)

100 Patents (Medical) associated with Birch cluster immunotherapy(Inmunotek SL)

Literatures (Medical) associated with Birch cluster immunotherapy(Inmunotek SL)

01 Jul 2023·World Allergy Organization Journal

Birch-induced allergic rhinitis: Results of exposure during nasal allergen challenge, environmental chamber, and pollen season

Article

Author: Domis, Nathalie ; Beck, Marine ; Dietsch, Frank ; de Blay, Frederic ; Gherasim, Alina

BackgroundPollen variation can affect field study data quality. Nasal allergen challenge (NAC) is considered the gold standard for evaluating allergic rhinitis, while environmental exposure chambers (EECs) are mainly used in phase 2 drug development studies. We aimed to study birch-induced allergic rhinitis under 3 different conditions.MethodsThis study included 30 participants allergic to birch pollen, based on birch skin prick test, specific immunoglobulin E (IgE), and positive NAC. Participants were exposed to placebo twice, followed by 2 consecutive 4-h birch airborne exposures, repeated on 2 occasions to evaluate reproducibility and priming effect. Nasal response was defined as total corrected nasal symptom score (ΔTNSS) ≥ 5 during NAC and EEC. The primary end-point was to measure TNSS during the last 2 h of first allergen exposure. TNSS was also analyzed during natural exposure.ResultsThe dose most commonly yielding positive TNSS during NAC was 175.2 ng/200 μL. Eighteen participants experienced ΔTNSS ≥5 during the last 2 h of the first exposure, whereas 21 had positive responses at all 4 exposures. Mean ΔTNSS was 1 with placebo versus 6 with birch. Exposures were reproducible, with no observed priming effect. Airborne Bet v 1 was 25 ng/m³, while the pollen measurement was 279/m³ during pollen season. TNSS reached 5 in 67.9% of participants during peak pollen season.ConclusionEEC outcomes were similar to those obtained with NAC and natural exposure, suggesting the usefulness of EEC in allergic rhinitis studies. The primary end-point was reached, as 60% of participants experienced nasal responses.

01 Oct 2022·Clinical and Translational Allergy

Subcutaneous birch pollen allergen immunotherapy with a depigmented polymerized extract shows only sustained and long‐term efficacy in a subgroup of monosensitized adults and adolescents with allergic rhinitis

Article

Author: Worm, Margitta ; Pfaar, Oliver ; Staubach, Petra ; Novak, Natalija ; Jutel, Marek ; Sager, Angelika

AbstractBackgroundAllergen immunotherapy (AIT) is an approved treatment for seasonal respiratory allergic diseases. A depigmented polymerized birch pollen extract for subcutaneous allergen immunotherapy (SCIT) has been demonstrated to be efficacious and safe in patients allergic to birch pollen and its homologous group.ObjectiveTo determine whether SCIT with a birch pollen formulation (5000 depigmented polymerized (DPP) units/mL) shows sustained and long‐term efficacy in adults and adolescents with birch‐pollen induced allergic rhinitis with or without intermittent asthma.MethodsA multicentre (n = 66), double‐blind, placebo‐controlled Phase III clinical trial was performed in the Czech Republic, Finland, Germany, Latvia, Lithuania, Poland and Russia. Participants were randomized 2:1 to active treatment (birch 5000 DPP/ml) or placebo for three years of SCIT and followed up for two treatment‐free years. The primary efficacy endpoint was the EAACI's combined symptom and medication score for rhinoconjunctivitis (CSMSEAACI).ResultsA total of 973 participants were screened and 649 were randomized (active treatment: n = 434; placebo: n = 215). The intention‐to‐treat analysis of the CSMSEAACI in the overall study population did not demonstrate statistically significant differences in years 1, 2 and 3. In a post‐hoc analysis, among the subgroup of patients monosensitized to birch pollen allergen only (n = 200), we observed a statistically significant difference (active treatment vs. placebo) in the CSMSEAACI in year 2, 3 and 5. The AIT's safety profile was good.ConclusionsSCIT with a depigmented polymerized birch pollen extract was safe. Sustained and long‐term efficacy in years 2, 3 and 5 in monosensitized patients, but not in polysensitized patients was demonstrated.(EudraCT 2012‐000414‐11)

17 Feb 2018·Journal of ChemotherapyQ4 · MEDICINE

Effects of a new combination of plant extracts plusd-mannose for the management of uncomplicated recurrent urinary tract infections

Q4 · MEDICINE

Article

Author: Nicolosi, Daria ; Tartaglia, Edoardo ; Corsello, Salvatore ; Davinelli, Sergio ; Vergalito, Franca ; Scapagnini, Giovanni ; Di Marco, Roberto ; Genovese, Carlo ; Tempera, Gianna ; Mangano, Katia

Urinary tract infections (UTIs) are an economic burden for public health. The increasing prevalence of resistant bacteria which cause UTIs may be related to the inappropriate prescription of antibiotics. The aim of this preliminary study was to evaluate whether three different combinations of plant extracts plus d-mannose are effective in preventing the recurrence of UTIs. Three groups of patients received three combinations of plant extracts in conjunction with d-mannose. These were: berberine, arbutin and birch (group A); berberine, arbutin, birch and forskolin (group B); and proanthocyanidins (group C). The clinical recurrence of cystitis at the end of treatment and during follow-up was determined by comparison with baseline measurements using the microbiological assessment of urine samples, vaginal swabs and vaginal smear slides. Patients in groups A and B had a lower incidence of episodes of recurrent cystitis during treatment and follow-up, samples with a significantly lower median bacterial load and a reduction of the grade of lactobacillary flora compared to patients in group C.

100 Deals associated with Birch cluster immunotherapy(Inmunotek SL)

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Indication	Highest Phase	Country/Location	Organization	Date
Allergic rhinoconjunctivitis	Phase 2	DE	ROXALL Medizin GmbH	25 Oct 2019
Conjunctivitis, Allergic	Phase 2	-	Inmunotek SL	-
Conjunctivitis, Allergic	Phase 2	-	ROXALL Medizin GmbH	-

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