EUCTR2011-001825-25-DE进行中（未招募）不适用
A multi-centre, randomized, double-blind, double-dummy, multiple-dose, crossover study to evaluate the pharmacodynamics, pharmacokinetics, safety and tolerability of orally inhaled indacaterol administered as either PulmoSphere or lactose-blend powder via the Concept1 device in adult patients with persistent asthma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male and female patients with asthma, aged 18 or above, diagnosed according to GINA guidelines (National Institute of Health, National Heart, Lung and Blood Institute, 2010) and who additionally meet the following criteria:
- •Patients receiving daily treatment with inhaled corticosteroid up to the maximum dose per day indicated in the package leaflet, in a stable regimen for at least 4 weeks prior to screening.
- •Patients with an FEV1 at screening and initial baseline of =50% of the predicted normal value for the patient. This criterion for FEV1 will have to be demonstrated after a washout period of at least 6 hours during which no short acting ß2-agonist has been inhaled, and a minimum washout of 48 hours for a long acting ß2-agonist or 7 days for
- •tiotropium/indacaterol. If appropriate washout has not been achieved when the patient attends for screening the Screening Part 1 assessments should be completed and the patient should return for Screening Part 2.
- •Patients who demonstrate an increase of =12% and =200 mL in FEV1 over their prebronchodilator value after inhaling a total of 400 µg of salbutamol (the reversibility test) as per ATS/ERS Task force: Standardisation of Lung Function Testing guidelines.
- •Reversibility will have to be demonstrated after an appropriate washout period as described in Section 3.1. The administration of salbutamol for the reversibility test is to be within 30 minutes after pre bronchodilator spirometry. If the patient does not show reversibility this may be repeated once.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 36
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who require the use of = 12 puffs/24 hours of rescue medication for 48 hours between screening and randomization.
- •Patients who have a decline in PEFR from the reference PEFR (taken at screening) of =30% for 5 of the 6 consecutive scheduled PEFR readings (includes readings taken at morning and evening) between screening and randomization.
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use effective contraception during the study
研究者
相似试验
进行中（未招募）
不适用
A study to evaluate the Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of Indacaterol Maleate as a new formulation in the Concept1 deviceAsthmaEUCTR2011-001825-25-GBovartis Pharma Services AG36
进行中（未招募）
1 期
Study to investigate efficacy, safety and tolerability of Furamag in the treatment of urinary tract infectionsMicrobiologically confirmed acute uncomplicated lower urinary tract infections in women.MedDRA version: 20.0Level: HLTClassification code 10046577Term: Urinary tract infectionsSystem Organ Class: 100000004862EUCTR2019-002747-14-LTOlainfarm AS745
进行中（未招募）
不适用
A multi-center, randomized, double-blind, double-dummy, parallel-group dose-finding study to evaluate the change in HbA1c after 12 weeks monotherapy with seven doses of LIK066 compared with placebo or sitagliptin in patients with type 2 diabetesType II Diabetes mellitusEUCTR2012-005793-63-HUovartis Pharma Services AG491
进行中（未招募）
不适用
Dose-finding study of LIK066 compared with placebo or sitagliptin to evaluate change in HbA1c in patients with diabetesType II Diabetes mellitusEUCTR2012-005793-63-PLovartis Pharma Services AG750
进行中（未招募）
不适用
Dose-finding study of LIK066 compared with placebo or sitagliptin to evaluate change in HbA1c in patients with diabetesType II Diabetes mellitusEUCTR2012-005793-63-ITovartis Farma SpA491