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

NCT ID: NCT01837927

Last Updated: 2016-08-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-04-30

Brief 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.

Detailed Description

A 52-week treatment, multicenter, randomized, open-label, parallel-group study to assess the efficacy of NVA237 (50μg once daily) using Tiotropium (5μg once daily) as an active control in Brazilian patients with moderate to severe Chronic Obstructive Pulmonary Disease.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NVA237

NVA237 inhaled via the Breezhaler® device once daily

Group Type: EXPERIMENTAL

NVA237

Intervention Type: DRUG

Once daily for 52 weeks

Tiotropium

Tiotropium 5μg inhaled via the Respimat® device once daily

Group Type: ACTIVE_COMPARATOR

Tiotropium Respimat®

Intervention Type: DRUG

Once daily for 52 weeks

Interventions

NVA237

Once daily for 52 weeks

Intervention Type: DRUG

Tiotropium Respimat®

Once daily for 52 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Men and women aged 40 years or over.
• History of current or former smoking of at least 10 pack-years

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Other Identifiers

CNVA237ABR01

Identifier Type: -

Identifier Source: org_study_id