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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00558285
Registration number
NCT00558285
Ethics application status
Date submitted
12/11/2007
Date registered
14/11/2007
Date last updated
30/11/2012
Titles & IDs
Public title
Safety and Tolerability of QVA149 (Indacaterol/Glycopyrrolate) Compared to Placebo and to Indacaterol in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)
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Scientific title
A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Determine the Effect of QVA149 on Mean 24-hours Heart Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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Secondary ID [1]
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CQVA149A2203
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD)
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - indacaterol/glycopyrrolate
Treatment: Drugs - indacaterol
Treatment: Drugs - glycopyrrolate
Treatment: Drugs - placebo
Experimental: indacaterol/glycopyrrolate 600/100 µg - Two capsules indacaterol/glycopyrrolate 300/50 µg delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study.
Experimental: indacaterol/glycopyrrolate 300/100 µg - One capsule indacaterol/glycopyrrolate 300/100 µg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study.
Experimental: indacaterol/glycopyrrolate 150/100 µg - One capsule indacaterol/glycopyrrolate 150/50 µg and one capsule 50 µg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study.
Active Comparator: indacaterol 300 µg - One capsule indacaterol 300 µg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study.
Placebo Comparator: placebo - Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.
The use of salbutamol/albuterol as rescue medication was permitted throughout the study.
Treatment: Drugs: indacaterol/glycopyrrolate
Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
Treatment: Drugs: indacaterol
Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
Treatment: Drugs: glycopyrrolate
Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
Treatment: Drugs: placebo
Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Mean 24 Hour Heart Rate at Day 14
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Assessment method [1]
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Heart rate was assessed by Holter monitoring and was measured over a 24 hour period at day 14. Heart rate was defined as the average value over the 24 hour monitoring period. The baseline measurement was the average heart rate taken from the 24 hour Holter monitoring period performed at screening or the last 24-hour period before taking the first dose of study drug. Least square means are based on the analysis of covariance: 24 hours mean heart rate = center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 min post salbutamol/albuterol + error.
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Timepoint [1]
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Baseline, Day 14
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Secondary outcome [1]
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Change From Baseline in Mean 24 Hour Heart Rate at Day 1
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Assessment method [1]
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Heart rate was assessed by Holter monitoring and was measured over a 24 hour period at day 1. Heart rate was defined as the average value over the 24 hour monitoring period. The baseline measurement was the average heart rate taken from the 24 hour Holter monitoring period performed at screening or the last 24-hour period before taking the first dose of study drug. Least squares means are based on the analysis of covariance: 24 hours mean heart rate = center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 min after inhalation of salbutamol/albuterol + error.
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Timepoint [1]
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Baseline, Day 1
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Secondary outcome [2]
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Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1 and Day 14
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Assessment method [2]
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Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 was defined as the mean of two measurements at 23 hours 15 minutes and 23 hour 45 minutes post dosing. Baseline is defined as the mean of the two values taken at 45 minutes and 15 minutes prior to dosing at day 1. Least square means are based on the analysis of covariance: response variable=center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 minutes post inhalation of salbutamol/albuterol.
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Timepoint [2]
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Day 1, Day 14
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Secondary outcome [3]
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Trough Forced Vital Capacity (FVC) at Day 1 and Day 14
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Assessment method [3]
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Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FVC was defined as the mean of two measurements at 23 hours 15 minutes and the 23 hours 45 minutes post dosing. Baseline was defined as the mean of the two values taken at 45 minutes and 15 minutes prior to dosing at day 1. Analysis of covariance: FVC parameter = center + treatment + baseline FVC + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 min after inhalation of salbutamol/albuterol + error.
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Timepoint [3]
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Day 1 and Day 14
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Secondary outcome [4]
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Change From Baseline in QTc (Fridericia's Formula) at Day 1
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Assessment method [4]
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The change from baseline in QTc at 30 minutes, 4 hours and 23 hours 45 minutes post dose on day 1. QT calculated (QTc) was calculated from the QT interval and RR (in seconds) using Fridericia's formula: QTc = QT / 3v RR. Least square means are based on the analysis of covariance: response variable = center + treatment + baseline value + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 min post inhalation of salbutamol/albuterol.
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Timepoint [4]
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Baseline, Day 1
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Secondary outcome [5]
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Change From Baseline in QTc (Fridericia's Formula) at Day 7
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Assessment method [5]
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The change from baseline in QTc at 30 minutes and 2 hours post dose on day 7. QT calculated (QTc) was calculated from the QT interval and RR (in seconds) using Fridericia's formula: QTc = QT / 3v RR. Least square means are based on the analysis of covariance: response variable = center + treatment + baseline value + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 min post inhalation of salbutamol/albuterol.
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Timepoint [5]
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Baseline, Day 7
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Secondary outcome [6]
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Change From Baseline in QTc (Fridericia's Formula) at Day 14
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Assessment method [6]
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The change from baseline in QTc at 30 minutes, 4 hours and 23 hours 45 minutes post dose on day 14. QT calculated (QTc) was calculated from the QT interval and RR (in seconds) using Fridericia's formula: QTc = QT / 3v RR. Least square means are based on the analysis of covariance: response variable = center + treatment + baseline value + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 minutes post inhalation of salbutamol/albuterol.
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Timepoint [6]
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Baseline, Day 14
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Eligibility
Key inclusion criteria
- Consented male or female adults aged =40 years
- Moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) according to
the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines (2006)
- Patients who have smoking history of at least 10 pack years
- Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) =30%
and <80% of the predicted normal and post-bronchodilator FEV1/Forced vital capacity
(FVC) <0.70 at Visit 1 and Visit 3
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Pregnant or nursing (lactating) women
- Patients requiring long term oxygen therapy (> 15 hours a day) on a daily basis for
chronic hypoxemia, or who have been hospitalized or visited an emergency room for a
COPD exacerbation in the 6 weeks prior to screening (Visit 1) or during the screening
period
- Patients who had a respiratory tract infection within 6 weeks of Visit 1 or at
screening
- Concomitant pulmonary disease, pulmonary tuberculosis (TB) (unless chest x-ray
confirms no longer active) or clinically significant bronchiectasis
- Any history of asthma
- Patients who have clinically relevant lab abnormalities / conditions such as (but not
limited to) long term prednisone therapy, unstable ischemic heart disease, left
ventricular failure, history of myocardial infarction, arrhythmia (excluding stable
atrial fibrillation [AF]), uncontrolled hypertension, narrow-angle glaucoma,
symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe
renal impairment, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic
state or any condition which might compromise patient safety or compliance, interfere
with evaluation, or preclude completion of the study
- Patients with a history of cardiac failure, life threatening arrhythmias (screening
Holter) and acute ischemic changes (screening ECG)
- Patients with a history of long QT syndrome or whose QTc (Fridericia method) interval
measured at screening (Visit 1) is prolonged (>450 ms for males or >470 for females)
- History of malignancy of any organ system, treated or untreated within the past 5
years
- Uncontrolled Type I / Type II Diabetes or blood glucose outside the normal range or
Hemoglobin A1C (HbA1c) >8.0% of total hemoglobin measured at Visit 1
Other protocol-defined inclusion/exclusion criteria may apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2008
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Sample size
Target
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Accrual to date
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Final
257
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Novartis Investigator Site - Adelaide
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Recruitment hospital [2]
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Novartis Investigator Site - Clayton
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Recruitment hospital [3]
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Novartis Investigator Site - Daw Park
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Recruitment hospital [4]
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Novartis Investigator site - Heidelberg
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Recruitment hospital [5]
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Novartis Investigator Site - Nedlands
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment postcode(s) [2]
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- Clayton
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Recruitment postcode(s) [3]
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- Daw Park
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Recruitment postcode(s) [4]
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- Heidelberg
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Recruitment postcode(s) [5]
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- Nedlands
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Recruitment outside Australia
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Belgium
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Brussels
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Belgium
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Jambes
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Belgium
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Jette
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Belgium
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Liege
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Belgium
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Oostende
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Canada
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Mississauga
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Canada
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Newmarket
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Canada
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Ottawa
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Canada
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Pointe-Claire
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Canada
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Quebec
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Canada
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Sainte-Foy
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France
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Ambroise
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France
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Lille
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France
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Marseille
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France
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Martigues
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France
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Nantes
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France
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Nice
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France
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Perpignan
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Germany
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Berlin
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Germany
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Dortmund
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Germany
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Erfurt
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Germany
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Hannover
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Germany
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Mainz
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Germany
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Marburg
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Italy
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Firenze
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Italy
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Modena
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Italy
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Trieste
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Spain
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Badalona
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Spain
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Baracaldo
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Spain
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Caceres
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Spain
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Centelles
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Spain
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Mataro
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Spain
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Valencia
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Turkey
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Istanbul
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Turkey
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Izmir
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
An investigational inhalation product (QVA149) for the treatment of patients with Chronic
Obstructive Pulmonary Disease (COPD) is being developed. This 14 day study will investigate
the effect on heart rate and cardiovascular effects to ensure the product is safe.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00558285
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharma AG
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Address
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Novartis Pharmaceuticals
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00558285
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