A multi-center, randomized, double-blind, placebo- controlled, two-period cross-over study to assess the effect of 50µg inhaled NVA237 on exercise endurance in patients with moderate to severe COPD - n/a
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 12.1Level: LLTClassification code 10010952Term: COPD
- Registration Number
- EUCTR2010-018597-20-DE
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
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 =40 and < 70% of the predicted normal, and post-bronchodilator FEV1/FVC < 0.7 during screening.
(Post refers to the highest postbronchodilator value 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
1.Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test); and women of child-bearing potential, UNLESS they meet protocol-specified requirements to prevent pregnancy
2.Patients who have had a COPD exacerbation (whether hospitalized or not) in the 6 weeks prior to Visit 1 or between Visit 1 and Visit 4.
3.Patients with a Wmax value <20 W (as determined by the incremental cycle endurance test) at Visit 2.
4.Patients, whose exercise endurance time at sub-maximal workload is above 25 min at baseline
5.Patients with contraindications to cardiopulmonary exercise testing
6.Patients who, in the judgment of the investigator or the responsible Novartis personnel have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to):
•unstable ischemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding chronic stable AF)
•history of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
•narrow-angle glaucoma
•symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention
•any condition which might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study
7.Patients with any history of asthma (as diagnosed by GINA guidlines)
Additional exclusion criteria are listed in the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method