A phase IIa, randomized, placebo-controlled, double-blind, cross-over study to evaluate safety and efficacy of subcutaneous administration of anakinra in patients with cystic fibrosis (ANAKIN)

Cystic fibrosis

Absolute pre-post change of the lung clearance index (LCI).

Evaluation of the safety and tolerability of the 28- days-treatment with anakinra by means of: o Physical examination o (Serious) adverse events o Laboratory safety parameters (clinical chemistry, hematology, clotting), Investigation of the effects of anakinra on lung function by means of absolute change in percentage points predicted forced expiratory volume in 1 second (FEV1 and FEV1 % pred)., Evaluation of the impact of anakinra on the quality-of-life (QoL) in the considered population by means of the Cystic Fibrosis Questionnaire – Revised (CFQ-R, German version)., Investigation of the effects of anakinra on lung function by means of absolute change in forced expiratory flow75 in liters/second and percent predicted (FEF75 and FEF75 % pred) and forced vital capacity in liter and percent predicted (FVC and FVC % pred)., Assessment of the influence of anakinra on lung structure and perfusion determined by chest MRI (optional sub-study)., Assessment of the influence of anakinra on airway inflammation by means of the following parameters: o Characterization of immune cells (absolute cell counts) in sputum samples o Inflammatory markers in sputum samples., Assessment of the influence of anakinra on the bronchial infection status by means of sputum microbiology., Assessment of sputum rheology

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Germany