Case Studies

Phase I/II study in which allergic asthma patients utilizing both non specific and specific allergen challenges, together with exNO level evaluation. The APS challenge system was used to facilitate both methacholine and allergen specific challenges. Having determined PD20 protocol dose at baseline, FEV1 response was tracked over a multiple dosing period in response to repeated allergen challenge.

Phase I/II study in which 24 moderate to severe COPD patients were enrolled into a multiple dosing protocol. Subjects were asked to undertake exercise challenge and spiroergometry assessments at scheduled time points. These assessments were complemented by body plethysmography assessment and additional routine spirometry.

Phase I/II study in which 36 HCV patients (GT1, GT3) were enrolled into a multiple dosing PK/PD study evaluating PK and viral load response. Subjects were required to participate in in-house periods followed or accompanied by out-patient assessments.

Phase I/II study in which 32 treatment naïve HIV patients were enrolled into a multiple dosing PK/PD study evaluating PK and viral load response. This was a combined in-house and out-patient study. It was facilitated in close collaboration with Charité Department of Infectious Diseases and its HIV out-patient clinic. The clinic provided support for patient enrollment and oversight of patients during the course of the study.

Phase I study in which 32 patients with mild-moderate hypertension were enrolled and washed out of existing anti-hypertensive therapy. Patients participated in a multi dose protocol during which ambulatory blood pressure monitoring and assessment of arterial stiffness was utilized.

Phase I study in which 48 MS patients (relapsing remitting, secondary progressive) were enrolled into a primarily PK study.

FTIH study conducted in two parts in healthy volunteers and 15 psoriasis patients. Study performed in close collaboration with Charité Dermatology department, incorporating PASI rating, UVB-irradiation, reflectometry, TEWL testing and skin biopsy.

FTIH study in which ultrasound was used to look for early improvement of synovitis in 58 RA patients. Study combined SAD & MAD dosing in a semi-parallel design with a single-center approach. Conducted with the support of Charité Rheumatology Department who provided expert implementation and evaluation of ultrasound procedures.

Phase I study conducted in close collaboration Charité Psychiatry Department. More than 25 patients with stable schizophrenia were enrolled into a complex Phase I protocol incorporating assessment of qEEG and event-related potentials. The study was implemented within the CRO Phase I unit, with the patients welfare assured by regular psychiatrist visits and support.

Complex Phase II study which Charité Research Organisation participated in and contributed the largest number of patients. Study conducted in patients with Type II diabetes taking metformin or metformin in combination with Sulfonylurea. Study involved multiple and extended in-house stays in combination with intense out-patient visit structure.