NL-OMON38556撤回3 期
A randomised, double-blind, placebo- and active-controlled parallel group study to assess the efficacy of 12 weeks of once daily treatment of two doses of orally inhaled tiotropium + olodaterol fixed dose combination (delivered by the Respimat inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD) - OTEMTO 1
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 62
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Diagnosis chronic obstructive pulmonary disease
- •- Relatively stable airway obstruction with post FEV1 ><=30 and
- •< 80% predicted normal and post FEV1/ FVC < 70%
- •- Male or female patients, 40 years of age or more
- •- Smoking history more than 10 pack years
排除标准
- •- Significant diseases other than COPD
- •- History of asthma
- •- COPD exacerbation in previous 3 months
- •- Completion of pulmonary rehabilitation program within previous 6 weeks or current participation in pulmonary rehabilitation program.
- •- Pregnant or nursing women
- •- Patients unable to comply with pulmonary medication restrictions
研究者
相似试验
进行中（未招募）
不适用
Tiotropium + olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary DiseaseMedDRA version: 17.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855Chronic Obstructive Pulmonary DiseaseEUCTR2013-002243-29-DKBoehringer Ingelheim Ltd800
进行中（未招募）
不适用
Tiotropium + olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary DiseaseMedDRA version: 14.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855Chronic Obstructive Pulmonary DiseaseEUCTR2013-002243-29-ESBoehringer Ingelheim España, S.A.1,066
进行中（未招募）
1 期
A study to investigate the effects of different dose levels of abediterol administered once daily during four weeks to patients with symptomatic asthma on inhaled corticosteroids compared to patients given an open label comparator or placebo. The study will evaluate the efficacy of abediterol, how this study drug is absorbed in the blood stream and how safe and tolerable it is for the patients.This study will be performed in men and non-pregnant, non-lactating women, all between 12 and 95 years of age with asthma symptomatic on ICS and fulfilling the reversibility criterion (improvement of FEV1=12% and 200 mL after administration of salbutamol/albuterol) at Visit 2.MedDRA version: 20.0 Level: LLT Classification code 10003560 Term: Asthma NOS System Organ Class: 100000015470EUCTR2016-004140-10-DEAstraZeneca AB600
进行中（未招募）
1 期
A study to investigate the effects of different dose levels of abediterol administered once daily during four weeks to patients with symptomatic asthma on inhaled corticosteroids compared to patients given an open label comparator or placebo. The study will evaluate the efficacy of abediterol, how this study drug is absorbed in the blood stream and how safe and tolerable it is for the patients.This study will be performed in men and non-pregnant, non-lactating women, all between 12 and 95 years of age with asthma symptomatic on ICS and fulfilling the reversibility criterion (improvement of FEV1=12% and 200 mL after administration of salbutamol/albuterol) at Visit 2.MedDRA version: 20.0Level: LLTClassification code 10003560Term: Asthma NOSSystem Organ Class: 100000004855EUCTR2016-004140-10-BGAstraZeneca AB600
进行中（未招募）
1 期
A study to investigate the effects of different dose levels of abediterol administered once daily during four weeks to patients with symptomatic asthma on inhaled corticosteroids compared to patients given an open label comparator or placebo. The study will evaluate the efficacy of abediterol, how this study drug is absorbed in the blood stream and how safe and tolerable it is for the patients.This study will be performed in men and non-pregnant, non-lactating women, all between 12 and 95 years of age with asthma symptomatic on ICS and fulfilling the reversibility criterion (improvement of FEV1=12% and 200 mL after administration of salbutamol/albuterol) at Visit 2.MedDRA version: 20.0 Level: LLT Classification code 10003560 Term: Asthma NOS System Organ Class: 100000015470EUCTR2016-004140-10-HUAstraZeneca AB600