Efficacy of NVA237 (50 μg o.d) Using Tiotropium (5μg μg o.d) as Active Control in COPD Patients.

• Status: Withdrawn
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the Efficacy of NVA237 (50 μg o.d) using tiotropium (5μg μg o.d) as active control in COPD patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Glycopyrrolate; Tiotropium Bromide

Criteria

Inclusion:

• Men and women aged 40 years or over.

• History of current or former smoking of at least 10 pack-years

• Cooperative outpatients, with a COPD diagnosis established by the measurement of FEV1/FVC < 0.7 post-bronchodilation in basal spirometry (without use of medication or post-washout). Moderate to severe stage patients will be included, with post-bronchodilator FEV1 between 30 and 80% of the normal value according to GOLD 2011 since the inclusion criteria in this trial will be based on spirometry results.

Exclusion:

• Pregnant women or nursing mothers

• History of asthma at visit 1 indicated by, but not limited to:

• Onset of respiratory symptoms suggestive of asthma (such as coughing, wheezing, shortness of breath) before the age of 40.

• History of diagnosed asthma

• History of respiratory tract infection within six weeks prior to Visit 1.

• History of hospitalization or emergency care for a COPD exacerbation in the 3 months prior to Visit 1.

• Subjects who require use of home oxygen therapy.

• Patients in the active phase of an assisted pulmonary rehabilitation program and patients who completed the rehabilitation program within 18 months from Visit 1 or 2 of the protocol.17,20

• Patients with known history and diagnosis of alpha-1 antitrypsin deficiency.

• Patients with concomitant lung disease, e.g.: tuberculosis (unless confirmed by radiography as inactive) or clinically significant bronchiectasis.

• Patients who in the investigator's judgment have an abnormality or significant medical condition such as: unstable ischemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (except chronic stable atrial fibrillation), history of malignancy of any system (including lung cancer) treated or not within the last 5 years, glaucoma, prostatic hyperplasia, moderate to severe renal impairment, urinary retention, any other condition that might compromise patient safety or compliance, interfere with the evaluations, or prevent the termination of their participation in the study.

• Patients with contraindications to tiotropium or ipratropium treatment or who have experienced undesirable reactions with inhaled anticholinergic agents or patients with a history of an undesirable reaction with sympathomimetic amines or inhaled medication with any of those components, or a history of hypersensitivity to any of the study medications, including rescue medication, or similar classes of medication.

• Patients using tiotropium, long-acting anticholinergics, short-acting anticholinergics, fixed combinations of inhaled beta agonists and inhaled corticosteroids, theophylline. In these cases, the patient is allowed, after agreeing to participate in the study, to enter a washout period from Visit

• Patients using inhaled steroids, alone or as an exchange in a fixed combination at equivalent doses, unless on a stable treatment for at least 1 month prior to randomization

• Patients using nonselective beta-blockers.

• Patients using cromoglycate, nedocromil, ketotifen and leukotriene antagonists unless on stable treatment for at least 1 month prior to randomization .

• Patients who used oral prednisone (or equivalent) over a long period, defined as ≥ 10 mg/day for at least 1 month prior to Visit 1

• Patients who used intramuscular depot corticosteroids within 30 days from Visit 1.

• Patients with a history of long QT Syndrome or with prolonged QTc (> 450 ms) measured at Visit 1 (Fridericia Method).

• Patients who, in the opinion of the investigator, have clinically significant abnormalities on ECG. These patients should not be re-screened.

• Other exclusion criteria may apply