Efficacy of NVA237 (50 μg o.d) Using Tiotropium (5μg μg o.d) as Active Control in COPD Patients.
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
NVA237
Tiotropium Respimat®
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Efficacy, NVA237, Tiotropium, Chronic Obstructive Pulmonary Disease, COPD
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NVA237
Tiotropium
Arm Description
NVA237 inhaled via the Breezhaler® device once daily
Tiotropium 5μg inhaled via the Respimat® device once daily
Outcomes
Primary Outcome Measures
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function.
Secondary Outcome Measures
Forced Expiratory Volume in 1 Second (FEV1) at day 1
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function.
Forced Expiratory Volume in 1 Second (FEV1) at day 7 and weeks 12, 24 and 52
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function.
Forced Expiratory Volume in 1 Second (FEV1) at weeks 24 and 52
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function.
Change From Baseline in Forced Vital Capacity (FVC)
Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.
FEV1 AUC 0-4h
Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.
Safety and tolerance of NVA237
All AEs and SAEs will be reported
Full Information
NCT ID
NCT01837927
First Posted
April 18, 2013
Last Updated
August 19, 2016
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01837927
Brief Title
Efficacy of NVA237 (50 μg o.d) Using Tiotropium (5μg μg o.d) as Active Control in COPD Patients.
Official Title
A 52-week Treatment, Multi-center, Randomized, Open Label, Parallel Group Study to Assess the Efficacy of NVA237 (50 μg o.d.) Using Tiotropium (5 μg o.d.) as an Active Control in Brazilian Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Withdrawn
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
April 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Efficacy, NVA237, Tiotropium, Chronic Obstructive Pulmonary Disease, COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NVA237
Arm Type
Experimental
Arm Description
NVA237 inhaled via the Breezhaler® device once daily
Arm Title
Tiotropium
Arm Type
Active Comparator
Arm Description
Tiotropium 5μg inhaled via the Respimat® device once daily
Intervention Type
Drug
Intervention Name(s)
NVA237
Intervention Description
Once daily for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Tiotropium Respimat®
Intervention Description
Once daily for 52 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Description
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function.
Time Frame
Baseline and 12 weeks after treatment.
Secondary Outcome Measure Information:
Title
Forced Expiratory Volume in 1 Second (FEV1) at day 1
Description
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function.
Time Frame
30 and 60 minutes post-dose on the first day of study treatment.
Title
Forced Expiratory Volume in 1 Second (FEV1) at day 7 and weeks 12, 24 and 52
Description
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function.
Time Frame
30 and 60 minutes post-dose on the 7th day of study treatment and at weeks 12, 24 and 52
Title
Forced Expiratory Volume in 1 Second (FEV1) at weeks 24 and 52
Description
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function.
Time Frame
pre-dose at weeks 24 and 52 of study treatment
Title
Change From Baseline in Forced Vital Capacity (FVC)
Description
Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.
Time Frame
Days 1 and 7, weeks 12, 24 and 52 of study treatment
Title
FEV1 AUC 0-4h
Description
Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.
Time Frame
05, 30, 60 minutes and 4 hours post-dose at days 1, 7 and week 12
Title
Safety and tolerance of NVA237
Description
All AEs and SAEs will be reported
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Efficacy of NVA237 (50 μg o.d) Using Tiotropium (5μg μg o.d) as Active Control in COPD Patients.
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