18 results
The objective of the proposed study (1237.25) is to evaluate maximal treatment effect in FEV1 and SGRQ after 12-weeks treatment with two different doses of tiotropium + olodaterol FDC (5*g/ 5*g and 5*g/ 2.5*g) by comparison with placebo in patients…
The objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium plus olodaterol fixed dose combination compared with the individual components tiotropium and olodaterol (delivered by…
Primary objective(s)• To evaluate the efficacy of blinatumomab to induce complete MRD responseKey secondary objective for patients with Ph-negative ALL • To evaluate the effect of blinatumomab on hematological relapseOther Secondary objectives• To…
The primary objective of the trial is to determine the 24-hour FEV1-time profile of tiotropium + olodaterol FDC (2.5/5 µg, 5/5 µg), administered once daily by the RESPIMAT Inhaler, after 6 weeks of treatment.
The primary objective of this study is to compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5 / 5 µg ; 5 / 5 µg) with tiotropium (5 µg), olodaterol (5 µg) and placebo on lung-hyperinflation and endurance time…
Primary objectives To demonstrate the non-inferiority of CHF 5993 pMDI versus fixed combination of fluticasone furoate/vilanterol plus tiotropium in terms of quality of life (change from baseline in the St. George*s Respiratory Questionnaire [SGRQ]…
The primary objective is to confirm that bronchodilator monotherapy (tiotropium) plus behavioural modification, bronchodilator combination therapy (tiotropium + olodaterol FDC) plus behavioural modification, and bronchodilator combination therapy (…
The aim of this study is to demonstrate that once daily treatment with tiotropium + olodaterol fixed dose combination will reduce the number of exacerbations over tiotropium 5 µg monotherapy.A secondary aim of the study is an assessment of a…
The primary objective of the study is to evaluate the effect of tiotropium + olodaterol FDCcompared to tiotropium monotherapy on the intensity of breathlessness during the 3min CSST.A secondary objective is to explore the relationship between…
The primary objective of the study is to assess the safety of 1 course of blinatumomab added to the Interfant-06 backbone in infants with newly diagnosed ALL. The secondary objectives are: • to assess the feasibility• to define the preliminary…
Primary:To evaluate the effects of singleinhaler triple therapy (FF/UMEC/VI)compared to multiple inhaler triplecombination therapy withbudesonide/formoterol plus tiotropiumafter 12 weeks of treatment on lungfunctionOther:To evaluate the effects of…
Primary objective: - To evaluate the systemic absorption and pharmacokinetics of topically applied NT-077 Secondary objectives: - To evaluate the safety and tolerability of topically applied NT-077- To evaluate the pharmacodynamic effect on sweat…
Primary objective:-To assess the proportion of patients that achieve MRD negative response (by PCR/FCM) after the first consolidation phase including blinatumomab.Secondary objectives:-To assess the MRD level following induction chemotherapy-To…
The primary objective is to improve the outcome (in terms of event-free survival (EFS) as the primary endpoint) of newly diagnosed KMT2A-rearranged (KMT2A-r) infant acute lymphoblastic leukemia (ALL) compared with the historical results of the…
• Primary- To determine the maximum tolerated dose (MTD) of blinatumomab in combination with pembrolizumab in adult subjects with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).• Secondary-To evaluate the safety, efficacy, and…
Primary:• To compare event-free survival (EFS) of subjects receiving blinatumomab alternating with low-intensity chemotherapy to EFS of subjects receiving standard of care (SOC) chemotherapy• To compare overall survival (OS) of blinatumomab…
Primary :• To evaluate the safety and tolerability of blinatumomab incombination with AMG 404 in adults with R/R B-ALL• To estimate the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of AMG 404 when combined with cIV…
Primary:Dose Escalation• Evaluate the safety and tolerability of subcutaneous (SC) blinatumomab for treatment of Relapsed or Refractory B cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)• Determine the maximum tolerated dose (MTD) and…