NL-OMON34669已完成3 期
A 26-week treatment, randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy, safety and tolerability of NVA237 in patients with chronic obstructive pulmonary disease (CNVA237A2304) - CNVA237A2304
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 32
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
- •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 (Stage II or Stage III) according to the (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 >=30% and < 80% of the predicted normal, and post-bronchodilator FEV1/FVC < 0.7 at Visit 2 (day -14)
- •5. Patients, according to daily electronic diary data between Visit 2 (-14) and Visit 3 (day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to Visit 3
排除标准
- •Oxygen therapy.
- •Lower airway infection in the past 6 weeks.
- •Bronchial asthma.
- •a1-antitrypsin deficiency.
- •Other relevant pulmonary diseases.
- •Use of ceratin COPD medications (see protocol for details).
- •Pregnancy and breast feeding. Inadequate contraception, if relevant.
研究者
相似试验
进行中（未招募）
不适用
A 26-week treatment, randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy, safety and tolerability of NVA237 in patients with chronic obstructive pulmonary disease.chronic obstructive pulmonary disease (COPD)MedDRA version: 12.0Level: LLTClassification code 10010952Term: COPDEUCTR2009-013504-32-NLovartis Pharma Services AG800
已完成
3 期
A Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus PlaceboCTRI/2009/091/000910ovartis Healthcare Pvt Ltd800
已完成
3 期
To asses the Efficacy, Safety and Tolerability of NVA237 in Patients With Chronic Obstructive Pulmonary DiseaseCTRI/2012/08/002907ovartis Healthcare Pvt Ltd450
进行中（未招募）
1 期
Controlled Clinical Study of Dupilumab in Patients with Nasal Polypsnasal polypsMedDRA version: 20.0Level: PTClassification code 10028756Term: Nasal polypsSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2015-003101-42-PLSANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT240
进行中（未招募）
1 期
A Controlled Clinical Study of Dupilumab in Patients with Nasal PolypsEUCTR2015-003101-42-HUSANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT240