EUCTR2010-018597-20-IT进行中（未招募）不适用
A multi-center, randomized, double-blind, placebocontrolled, two-period cross-over study to assess the effect of 50 µg inhaled NVA237 on exercise endurance in patients with moderate to severe COPD - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
- •1. Male or female adults aged =40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
- •2. Patients with moderate to severe stable COPD (clinical diagnosis in compliance with GOLD Guidelines 2008).
- •3. Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.).
- •4. Patients with a post-bronchodilator FEV1 =35% and < 70% of the predicted normal, and post-bronchodilator FEV1/FVC < 0.7 during screening.
- •(Post refers to 30 min after inhalation of 80 µg ipratropium bromide).
- •5. Increase in FEV1 from Pre-bronchodilator to Post-bronchodilator assessment of at least 5%.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Pregnant women or nursing mothers or of child-bearing potential except for the cases listed into protocol. - Patients who have had a COPD exacerbation in the 6 weeks prior to Visit 1 or between V. 1 and V. 4.- Patients who have had a lower respiratory tract infection in the 6 weeks prior to V. 1.- Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia.- Patients with resting (5 min) oxygen SaO2 saturation on room air of < 85%.- Patients with a Wmax value <20 W at V. 2.-Patients, whose exercise endurance time at sub-maximal workload is above 25 min at baseline; - Patients with contraindications (see example into Protocol) to cardiopulmonary exercise testing ;- Patients involved in the active phase of a supervised Pulmonary Rehabilitation Program.- Patients who have a clinically relevant laboratory abnormality or a clinically significant condition such the ones described into the Protocol as example; - Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency.- Patients with concomitant pulmonary disease, e.g., pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis.- Patients with any history of asthma or with allergic rhinitis who use H1 antagonists or intranasal corticosteroids intermittently are to be excluded. Treatment with a stable dose is permitted (constant dose for at least 1 month prior to V. 2).- Patients with a history of long QT syndrome or whose QTc is prolonged at screening. - Patients who have a clinically significant abnormality on the screening or baseline ECG who in the judgement of the investigator would be at potential risk if enrolled into the study. - Patients contraindicated for treatment with, or having a history of reactions/hypersensitivity to any of the class drugs described into the Protocol, included, for example, anti-cholinergic agents, long- and short-acting ß2-agonists, sympathomimetic amines; - Treatments for COPD and allied conditions: the medications described into the Protocol should not be used between V. 1 and V. 4 and then through the subsequent course of the study. Further to this, into the Protocol, is specified the minimum washout prior to V. 2.- Patients who need the following treatments for COPD and allied conditions (e.g. allergic rhinitis) unless they have been stabilized as follows: Inhaled corticosteroids in recommended and constant doses and dose regimens (previously given as either part of a fixed dose combination of LABA+ICS or ICS as monotherapy) for at least 1 month prior to V. 2, Intranasal corticosteroids in recommended and constant doses and dose regimens for at least 1 month prior to V. 2, H1 antagonists in recommended and constant doses and dose regimens for at least 5 days prior to V. 2;- Other excluded medications: Leukotriene antagonists (7 days prior to V. 2), Cromoglycate, nedocromil, ketotifen (7 days prior to V. 2), Intramuscular glucocorticosteroid e.g. Kenalog: unless discontinued 3 months prior to V. 2, Parenteral or oral glucocorticosteroids unless discontinued 1 month prior to V. 2;- Patients unable to use a dry powder inhaler device or pressurized rescue medication) or unable to use an electronic patient diary;- Patients who are known to be unreliable or noncompliant or with any condition or prior or present treatment rendering the patient not eligible for the study;- Use of other invest. drugs at the time of enrollment, or within 30 days or 5 halflive
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