A randomized, double-blind, placebo-controlled, 4 period incomplete block cross-over, multi-center, multiple dose (7 days) dose-ranging study to assess the efficacy and safety of 4 doses of NVA237 in patients with stable Chronic Obstructive Pulmonary Disease (COPD), compared to seven days treatment with tiotropium (18µg once daily, open label) as an active control.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 73

Inclusion Criteria

•Male or female adults aged = 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
•Patients with moderate to severe COPD according to the GOLD Guidelines (2006).
•Patients who have smoking history of at least 10 pack years.
•Patients with a post-bronchodilator FEV1 =30 % and < 80 % of the predicted normal, and post-bronchodilator FEV1/FVC < 0.7 at Visit 2.

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

Exclusion Criteria

•Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test) and females of childbearing potential who do not use a reliable contraceptive method.
•Patients requiring oxygen therapy on a daily basis for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 1 or during the run-in period (between Visit 1 and Visit 3).
•Patients who have had respiratory tract infection within 6 weeks prior to Visit 1.
•Patients who develop a respiratory tract infection during the screening period (up to Visit 3) must discontinue from the trial, but will be permitted to re-enroll at a later date (at least 6 weeks after the resolution of the respiratory tract infection).
•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, cancers, left ventricular failure, long term prednisone therapy, history of myocardial infarction, arrhythmia (all), narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment.
•Patients with a history of asthma indicated by (but not limited to):
a) Blood eosinophil count > 400/mm3
b) Onset of symptoms prior to age 40 years.
•Patients contraindicated for tiotropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents.
•Patients with a history of long QT syndrome or whose QTc measured at Visit 1 is prolonged (>440 ms for males or >460 for females).
•Patients with a history of untoward reactions to sympathomimetic amines or inhaled medication or any component thereof.
•Treatments for COPD and allied conditions : the following medications should not be used between Visits 1 and 18. The minimum washout prior to Visit 2 is specified below :
The long acting anticholinergic agent tiotropium :7 days.
Short acting anticholinergics : 8 h
Fixed combinations of beta 2-agonists and inhaled corticosteroids : 48 h - Patients taking fixed combinations of corticosteroid/beta-agonist prior to Visit 1 should be transferred to the same dose of steroid contained in the fixed combination and on-demand rescue medication for a period of 2 weeks prior to Visit 2.
Long-acting beta 2-agonists : 48 h
Short acting beta 2-agonists (other than those prescribed in the study): 6 hours
Theophylline (any formulation): 7 days
Combinations of inhaled anticholinergics and beta agonists: 24 hours
Patients taking fixed combinations of corticosteroid/beta-agonist prior to Visit 1 should be transferred to the same dose of steroid contained in the fixed combination and on-demand rescue medication for a period of 2 weeks prior to Visit 2.
•Patients who need the following treatments for COPD and allied conditions unless they have been stabilized for at least one month prior to visit 1 :
•Inhaled or nasal corticosteroids
•Cromoglycate, nedocromil, ketotifen in recommended and constant doses and dose regimens
•Patients taking beta blocking agents
•Patients unable to use a dry powder inhaler (Single Dose Dry Powder Inhaler or HandiHaler® type) device or a pMDI (rescue medication), perform spirometry measurements or complete a patient log.
•Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of Visit 1, whichever is longer.
•History of hypersensitivity to any of the st

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

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