Short-term growth study in children with asthma treated with fluticasone propionate / formoterol spray (flutiform®). Undersøgelse af korttidsvækst hos børn med astma i behandling med fluticasonpropionat /formoterol spray (flutiform®) •To show non-inferiority of flutiform pMDI 50/5 µg (2 puffs bid) versus fluticasone pMDI 50 µg (2 puffs bid) based on the mean lower leg growth rates.

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Intrathecal chemotherapy with liposomal ara-C (Depocyte) in leptomeningeal metastases of solid tumors: a phase III study The main objective is to assess the clinical benefits of treatment with DepoCyte® in comparison to no Intra Thecal (IT) therapy in adult patients with leptomeningeal metastasis (LM) from solid tumors.

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A phase II prospective non-comparative multicenter clinical trial to determine the efficacy and safety of intrathecal liposomal cytarabine (DepoCyte®) in preventing CNS-relapse in patients with aggressive Non-Hodgkin-Lymphomas at risk for CNS metastasis Incidence of confirmed leptomeningeal metastasis (CNS relapse) during the post treatment observation period of one year verified by CNS cytology

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A double-blind, randomised, incomplete block, crossover, placebo-controlled, dose-response study to assess bronchial hyperresponsiveness and airway inflammation effects of FlutiForm® pMDI low and high dose in adult subjects with mild to moderate asthma The primary objective of this study is to demonstrate a dose-response relationship between high dose (250/10 µg, 2 puffs) and low dose (50/5 µg, 2 puffs) FlutiForm® by comparing the effects of each do...

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A double blind, double dummy, randomised, multicentre, four arm parallel group study to assess the efficacy and safety of FlutiForm™ pMDI 250/10 µg (2 puffs bid) vs Fluticasone pMDI 250 µg (2 puffs bid) plus Formoterol pMDI 12 µg (2 puffs bid) administered concurrently in adult subjects with severe persistent, reversible asthma To show non-inferiority in the efficacy of FlutiForm pMDI 250/10 µg (2 puffs bid) vs Fluticasone pMDI 250 µg (2 puffs bid) plus Formoterol pMDI 12 µg (2 puffs bid) administered concurrently, based on ...

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A double blind, double dummy, randomised, multicentre, two arm parallel group study to assess the efficacy and safety of FlutiForm® pMDI 125/5 µg (2 puffs bid) vs Symbicort® Turbohaler® 200/6 µg (2 puffs bid) in adolescent and adult subjects with moderate to severe persistent, reversible asthma To show non-inferiority in the efficacy of FlutiForm® pMDI 125/5 µg (2 puffs bid) vs Symbicort® Turbohaler® 200/6 µg (2 puffs bid), based on the mean change in the pre-morning dose value of forced exp...

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Phase III, open-label, randomised, multicentre efficacy and safety study of bendamustine hydrochloride versus chlorambucil in treatment-naive patients with (Binet Stage B/C) chronic B-Cell Lymphocytic Leukaemia (B-CLL) requiring therapy Not provided at time of registration

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An open, randomised, parallel group, multicentre study to compare the efficacy and safety of FlutiForm pMDI vs Seretide pMDI in adult subjects with mild to moderate-severe persistent, reversible asthma The primary objective of this study is to show comparable efficacy of FlutiForm with Seretide based on mean Forced Expiratory Volume in the 1st second (FEV1) values.

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An open, randomised, parallel group, multicentre study to compare the efficacy and safety of FlutiForm pMDI vs Seretide pMDI in paediatric subjects with mild to moderate persistent, reversible asthma The primary objective of this study is to show comparable efficacy of FlutiForm with Seretide based on mean Forced Expiratory Volume in the 1st second (FEV1) values.

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