Last update 01 Nov 2024

ClinCompetence Cologne GmbH

Private Company

Last update 01 Nov 2024

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Translational Medicine

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Clinical Trials associated with ClinCompetence Cologne GmbH

CTIS2023-508013-16-00 / Not yet recruiting

A prospective, randomized, double-blind placebo-controlled multicentre study with mannan-conjugated birch pollen allergoids administered subcutaneously to adolescent and adult patients with birch pollen-induced allergic rhinitis or rhinoconjunctivitis. - T502-SIT-068

Start Date26 Feb 2024

Sponsor / Collaborator

ClinCompetence Cologne GmbH

[+1]

NCT04703673 / CompletedNot Applicable

Non-interventional Study on the Quality of Life Before and After Intake of Sinolpan® (Forte) in Inflammatory Diseases of the Respiratory Tract - an Anonymous Patient Survey

This non-interventional study investigates the Quality of Life of patients suffering from rhinosinusitis. Patients who seek advice in a pharmacy and choose to intake Sinolpan® or Sinolpan® forte or to use nasally applied α-sympathomimetics can participate in this anonymous patient survey.

Start Date08 Jan 2021

Sponsor / Collaborator

Engelhard Arzneimittel GmbH & Co. KG

[+1]

100 Clinical Results associated with ClinCompetence Cologne GmbH

0 Patents (Medical) associated with ClinCompetence Cologne GmbH

Literatures (Medical) associated with ClinCompetence Cologne GmbH

01 Apr 2024·Allergy

A randomized, double‐blind, placebo‐controlled trial with mannan‐conjugated birch pollen allergoids

Article

Author: Allekotte, Silke ; Cuevas, Mandy ; Raskopf, Esther ; Acikel, Cengizhan ; Zeyen, Christoph ; Casanovas, Miguel ; Sahin, Hacer ; Subiza, José Luis ; Mösges, Ralph ; Shamji, Mohamed H

AbstractBackgroundThere is still great need to develop new strategies to improve the efficacy of allergen immunotherapies with optimal safety standards for patients. A new promising approach is to couple allergoids to mannan. The objective of this phase IIa/IIb study was to identify the optimal dose of mannan‐conjugated birch pollen allergoids for the short‐course treatment of birch pollen–induced allergic rhinoconjunctivitis.MethodsFor this prospective, randomized, double‐blind, placebo‐controlled, dose‐finding study, 246 birch pollen–allergic adults received 0.5 mL placebo or 1000, 3000 or 10,000 mTU/mL of mannan‐conjugated birch pollen allergoids at five pre‐seasonal visits. Efficacy was assessed by comparing allergic rhinoconjunctivitis symptoms and use of anti‐allergic medication during the peak of the birch pollen season 2020. Immunologic, tolerability and safety effects were also analysed.ResultsThe highest dose of mannan‐conjugated birch pollen allergoids reduced the combined symptom and medication score during the peak birch pollen season by a median of 24.7% compared to placebo. The production of Bet v 1 specific IgG4 significantly increased in a dose‐dependent manner (3.6‐ and 4.5‐fold) in the 3000 and 10,000 mTU/mL groups. The Bet v 1 specific IgE/IgG4 ratio was also strongly reduced (up to −70%). No fatalities nor serious adverse events were reported, and no adrenaline was used. In total, four systemic reactions occurred (two grade I and two grade II).ConclusionAll doses of mannan‐conjugated birch pollen allergoids can be considered as safe. Since the application of 10,000 mTU/mL resulted in the highest efficacy, this dose qualifies for further investigation.

07 Sep 2023·Journal of clinical medicine

Effectiveness and Tolerability of Ectoin^® Mouth and Throat Spray Althaea Honey (ERS09) for Sore Throat due to Acute Pharyngitis and Dry Cough: A Multicentre, Actively Controlled, Open Label Study in Germany.

Article

Author: Mösges, Ralph ; Pieper-Fürst, Ursula ; Santos, Dunia ; Sent, Ulrike ; Acikel, Cengizhan ; Roventa, Don Lorenzo Constantin

Acute pharyngitis can cause sore throat. This multicentre, active-controlled, randomised, open-label, and parallel-group study, conducted according to the German Medical Devices Act, compared the effectiveness and tolerability of ERS09 mouth and throat spray with a well-established device for the treatment of sore throat caused by acute pharyngitis and dry cough. Patients were randomised 1:1 into ERS09/comparator groups (EMSER^® Sore Throat Spray) for 7 ± 2 days. Patients and investigators reported effectiveness (change in total symptom score [TSS]) and safety endpoints (incidence of adverse events [AEs]; adverse device effects [ADEs]). A total of 186 patients were included (ERS09: n = 92; comparator: n = 94). The baseline-adjusted mean TSS over 7 days was -90.14 and -74.91 in the ERS09 and comparator groups, respectively (p < 0.05). The majority of patients reached a 50% reduction in symptoms by day 6 (ERS09 = 78.85; comparator = 75.8%). Most patients reported a soothing effect within five minutes (ERS09 = 82%; comparator = 71%). Improvements in individual symptoms were similar with no significant differences between groups; more patients in the ERS09 group reported an improvement in pharyngeal redness/swelling. Three AEs unrelated to medication, one ADE following ERS09, and no serious AE/ADE were reported. ERS09 was as well tolerated and effective as the established device, showing greater improvement in the management of some symptoms and greater patient preference.

01 Aug 2023·The journal of allergy and clinical immunology. Global

Validation of AI-based software for objectification of conjunctival provocation test.

Article

Author: Mösges, Ralph ; Kalaidzidis, Yannis ; Bodrova, Kira ; Kalaitzidou, Alexandra ; Yarin, Yury

BackgroundProvocation tests are widely used in allergology to objectively reveal patients' sensitivity to specific allergens. The objective quantification of an allergic reaction is a crucial characteristic of these tests. Because of the absence of objective quantitative measurements, the conjunctival provocation test (CPT) is a less frequently used method despite its sensitivity and simplicity.ObjectiveWe developed a new artificial intelligence (AI)-based method, called AllergoEye, for quantitative evaluation of conjunctival allergic reactions and validated it in a clinical study.MethodsAllergoEye was implemented as a 2-component system. The first component is based on an Android smartphone camera for screening and imaging the patient's eye, and the second is personal computer-based for image analysis and quantification. For the validation of AllergoEye, an open-label, prospective, monocentric study was carried out on 41 patients. Standardized CPT was performed with sequential titration of grass allergens in 4 dilutions, with the reaction evaluated by subjective/qualitative symptom scores and by quantitative AllergoEye scores.ResultsAllergoEye demonstrated high sensitivity (98%) and specificity (90%) as compared with human estimation of allergic reaction. Tuning cutoff thresholds allowed us to increase the specificity of AllergoEye to 97%, at which point the correlation between detected sensitivity to allergen and specific IgE carrier-polymer system class becomes obvious. Strikingly, such correlation was not found with sensitivity to allergen detected on the basis of subjective and qualitative symptom scores.ConclusionThe clinical validation demonstrated that AllergoEye is a sensitive and efficient instrument for objective measurement of allergic reactions in CPT for clinical studies as well as for routine therapy control.

100 Deals associated with ClinCompetence Cologne GmbH

100 Translational Medicine associated with ClinCompetence Cologne GmbH

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