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QVA vs. Salmeterol/Fluticasone, 52-week Exacerbation Study, FLAME (EFfect of Indacaterol Glycopyronium Vs Fluticasone Salmeterol on COPD Exacerbations)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01782326
First received: January 30, 2013
Last updated: May 5, 2016
Last verified: May 2016
  Purpose
This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to very severe COPD.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: QVA149
Drug: Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A 52-week Treatment, Multi-center, Randomized, Double-blind, Double Dummy, Parallel-group, Active Controlled Study to Compare the Effect of QVA149 (Indacaterol Maleate / Glycopyrronium Bromide) With Salmeterol/Fluticasone on the Rate of Exacerbations in Subjects With Moderate to Very Severe COPD. (FLAME).

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Rate of COPD Exacerbations [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    COPD exacerbations starting between first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event. Estimates are from a generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. As the offset variable log(exposure time in years) was used.


Secondary Outcome Measures:
  • Time to First COPD Exacerbation. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    First COPD exacerbations starting between first dose and one day after last treatment are included. Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region.

  • Rate of Moderate to Severe COPD Exacerbations. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    COPD exacerbations starting between date of first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event with the worst severity. A COPD exacerbation of moderate severity meets the symptoms definition in the protocol and requires treatment with systemic corticosteroids and/or antibiotics. A severe COPD exacerbation requires hospitalization. Estimates are from a generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used.

  • Time to First Moderate to Severe COPD Exacerbation. [ Time Frame: 52 weeks. ] [ Designated as safety issue: No ]
    First COPD exacerbations starting between first dose and one day after last treatment are included. Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region.

  • Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    COPD exacerbations starting between date of first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event with the worst severity. Estimates are from a generalized linear model assuming a negative binomial distribution with fixed effects of treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used.

  • Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Estimates are from a generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used. COPD exacerbations starting between first dose and one day after last treatment are included .

  • Rate of Moderate to Severe COPD Exacerbations Requiring Hospitalization. COPD Exacerbations Starting Between First Dose and One Day After Last Treatment Are Included. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    All exacerbations requiring hospitalization are considered severe according to protocol definitions so this is the rate of severe COPD exacerbations only. Note - an ER visit of longer than 24 hours was considered a hospitalization.

  • Rate of Moderate to Severe COPD Exacerbations Requiring Re-hospitalization Within 30 Days [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Re-hospitalizations are defined as hospitalizations starting within the first 30 days after a severe COPD exacerbation and between first dose and one day after date of last treatment. Generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used. COPD exacerbations starting between first dose and one day after last treatment are included.

  • Time to First Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included.

  • Time to First Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included.

  • Time to First Moderate to Severe COPD Exacerbations Requiring Hospitalization [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included.

  • Time to First Moderate to Severe COPD Exacerbations Requiring Re-hospitalization Within 30 Days [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included.

  • Forced Expiratory Volume in 1 Second [ Time Frame: Baseline, day 1 (30 min and one hour post dose) ] [ Designated as safety issue: No ]
    Change from baseline. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, region, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.

  • Forced Expiratory Volume in 1 Second [ Time Frame: Baseline, 4 weeks ] [ Designated as safety issue: No ]
    Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.

  • Forced Expiratory Volume in 1 Second [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.

  • Forced Expiratory Volume in 1 Second [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: No ]
    Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.

  • Forced Expiratory Volume in 1 Second [ Time Frame: Baseline, 38 weeks ] [ Designated as safety issue: No ]
    Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.

  • Forced Expiratory Volume in 1 Second [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
    Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.

  • Change From Baseline in Forced Expiratory Volume in 1 Second AUC (0-12h) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
    Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time"

  • Change From Baseline in Total St. George's Respiratory Questionnaire Score [ Time Frame: Baseline, 4 weeks ] [ Designated as safety issue: No ]
    The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.

  • Change From Baseline in Total St. George's Respiratory Questionnaire Score [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.

  • Change From Baseline in Total St. George's Respiratory Questionnaire Score [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: No ]
    The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.

  • Change From Baseline in Total St. George's Respiratory Questionnaire Score [ Time Frame: Baseline, 38 weeks ] [ Designated as safety issue: No ]
    The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.

  • Change From Baseline in Total St. George's Respiratory Questionnaire Score [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
    The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.

  • Change From Baseline in the Number of Puffs of Rescue Medication [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
    A linear mixed model (LMM) was used for this analysis Change from baseline in mean number of puffs. LMM including: treatment, baseline value, smoking status at screening, ICS use at screening, airflow limitation severity, region and random effect of center nested within region.

  • Change From Baseline in the Safety of QVA149 ((110/50 μg o.d.) vs Fluticasone/Salmeterol (500/50μg Bid) in Terms of HPA Axis Function, as Determined by Collection of 24-hour Urine Cortisol. [ Time Frame: Baseline, 52 Weeks ] [ Designated as safety issue: Yes ]
    Urine cortisol/creatinine ratio

  • Change From Baseline in Forced Vital Capacity [ Time Frame: 4 Weeks, 12 Weeks, 26 Weeks, 38 Weeks, 52 Weeks ] [ Designated as safety issue: No ]
    Change from baseline in trough value (average of values measured 45 and 15 minutes prior to the morning dose). Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FVC was defined as the average of the pre-dose FVC measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FVC measurements, smoking status at screening, screening inhaled corticosteroid (ICS) use, region, baseline FVC * visit interaction, and visit, treatment * visit interaction

  • Number of Patients With Adverse Events, Serious Adverse Events, and Death [ Time Frame: 52 weeks of treatment + 30 days ] [ Designated as safety issue: Yes ]
    The overall rate of adverse events reported from initiation through 30 days post last dose.


Enrollment: 3362
Study Start Date: July 2013
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QVA149
QVA149 (110/50 μg) once daily
Drug: QVA149
QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept 1 SDDPI.
Active Comparator: Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS)
Salmeterol/fluticasone (50/500μg) b.i.d
Drug: Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS)
Salmeterol/fluticasone dry inhalation powder delivered via the Accuhaler device.

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent must be obtained before any assessment is performed
  • Male or female adults aged ≥40 years
  • Patients with stable Chronic Obstructive Pulmonary Disease ( COPD) according to the current GOLD strategy (GOLD 2011)
  • Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years)
  • Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥25 and < 60% of the predicted normal value, and post-bronchodilator FEV1/FVC (Forced Vital Capacity) < 0.70 at day -28. (Post refers to 1 hour after sequential inhalation of 84 µg (or equivalent dose) of ipratropium bromide and 400 µg of salbutamol)
  • A documented history of at least 1 COPD exacerbation in the previous 12 months that required treatment with systemic glucocorticosteroids and/or antibiotics
  • Patients taking stable COPD medication (at least 60 days) prior to day 28
  • Patients with an mMRC grade of at least 2 at day 28

Exclusion Criteria:

  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG (human Chorionic Gonadotropin) laboratory test
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
  • Patients with Type I or uncontrolled Type II diabetes
  • Patients with a history of long QT syndrome or whose QTc measured at day 28 (Fridericia method) is prolonged (>450 ms for males and females) and confirmed by a central assessor. These patients should not be re-screened
  • Patients who have a clinically significant ECG abnormality prior to randomization. (These patients should not be re-screened)
  • Patients who have a clinically significant laboratory abnormality at screening
  • Patients who have clinically significant renal, cardiovascular (such as but not limited to unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, myocardial infarction), arrhythmia (see below for patients with atrial fibrillation), neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of the efficacy and safety of the study treatment
  • Patients with paroxysmal (e.g. intermittent) atrial fibrillation are excluded
  • Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., selective beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, atrial fibrillation must be present at both pre-randomization visits, with a resting ventricular rate < 100/min. At screening the atrial fibrillation must be confirmed by central reading
  • Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof: anticholinergic agents, long and short acting beta-2 agonists, sympathomimetic amines, lactose or any of the other excipients of trial medication
  • Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
  • Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention. Benign Prostatic Hyperplasia (BPH) patients who are stable on treatment can be considered
  • Patients who have not achieved an acceptable spirometry results at screening in accordance with American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria for acceptability (one retest may be performed for patients that don't meet the acceptability criteria)
  • Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids and/or hospitalization in the 6 weeks prior to screening
  • Patients who develop a COPD exacerbation of any severity (mild/moderate/severe) between screening and treatment will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation
  • Patients who have had a respiratory tract infection within 4 weeks prior to screening
  • Patients who develop a respiratory tract infection between screening and prior to treatment will not be eligible, but will be permitted to be re-screened 4 weeks after the resolution of the respiratory tract infection
  • Patients requiring long term oxygen therapy prescribed for >12 hours per day
  • Patients with any history of asthma
  • Patients with an onset of respiratory symptoms, including a COPD diagnosis prior to age 40 years
  • Patients with a blood eosinophil count > 600/mm3 at screening
  • Patients with allergic rhinitis who use a H1 antagonist or intra-nasal corticosteroids intermittently (treatment with a stable dose or regimen is permitted)
  • Patients with concomitant pulmonary disease (e.g. lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension)
  • Patients with clinically significant bronchiectasis
  • Patients with a diagnosis of α-1 anti-trypsin deficiency
  • Patients with active pulmonary tuberculosis, unless confirmed by imaging to be no longer active
  • Patients with pulmonary lobectomy or lung volume reduction surgery or lung transplantation
  • Patients participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the study. (Maintenance program is permitted.)
  • Patients receiving any medications in the classes listed in the protocol
  • Patients receiving any COPD related medications in the classes specified in the protocol must undergo the required washout period prior to screening and follow the adjustment to treatment program
  • Use of other investigational drugs/devices (approved or unapproved) at the time of enrollment, or within 30 days or 5 half-lives of screening, whichever is longer
  • Patients unable to use an electronic patient diary and EXACT pro diary
  • Patients unable to use a dry powder inhaler device, Metered Dose Inhaler (MDI) or a pressurized MDI (rescue medication) or comply with the study regimen.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782326

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Locations
Argentina
Novartis Investigative Site
Caba, Buenos Aires, Argentina, 1122
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1056ABJ
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1122AAK
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1414AIF
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1424BSF
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1425BEA
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1425BEN
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1426ABP
Novartis Investigative Site
Lanus, Buenos Aires, Argentina, B8000XAV
Novartis Investigative Site
Mar del Plata, Buenos Aires, Argentina, 7600
Novartis Investigative Site
Mar del Plata, Buenos Aires, Argentina, B7600FZN
Novartis Investigative Site
Mar del Plata, Buenos Aires, Argentina, B7600
Novartis Investigative Site
Buenos Aires, Capital Federal, Argentina, C1028AAP
Novartis Investigative Site
Concepcion del Uruguay, Entre Ríos, Argentina, 3260
Novartis Investigative Site
Rosario, Santa Fe, Argentina, S2000AII
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Rosario, Santa Fe, Argentina, S2000DBS
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San Miguel de Tucuman, Tucuman, Argentina, 4000
Novartis Investigative Site
San Miguel de Tucuman, Tucuman, Argentina, T4000IFL
Novartis Investigative Site
Buenos Aires, Argentina, 1425
Novartis Investigative Site
Buenos Aires, Argentina, C1120AAC
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Ciudad de Buenos Aires, Argentina, C1425AUA
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Mendoza, Argentina, 5500
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Mendoza, Argentina, M5500CBA
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Salta, Argentina, 4000
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Santa Fe, Argentina, S3000FIL
Austria
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Innsbruck, Tyrol, Austria, 6020
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Feldbach, Austria, 8330
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Feldkirch, Austria, 6800
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Graz, Austria, A-8036
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Grieskirchen, Austria, 4710
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Linz, Austria, 4020
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Salzburg, Austria, 5020
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Thalheim bei Wels, Austria, 4600
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Vienna, Austria, A-1230
Novartis Investigative Site
Wels, Austria, 4600
Belgium
Novartis Investigative Site
Gosselies, BEL, Belgium, 6041
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Genk, Limburg, Belgium, 3600
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Aalst, Belgium, 9300
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Brussel, Belgium, 1090
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Bruxelles, Belgium, 1000
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Bruxelles, Belgium, 1070
Novartis Investigative Site
Bruxelles, Belgium, 1200
Novartis Investigative Site
Erpent, Belgium, 5101
Novartis Investigative Site
Gent, Belgium, 9000
Novartis Investigative Site
Gilly, Belgium, 6060
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Hasselt, Belgium, 3500
Novartis Investigative Site
Leuven, Belgium, 3000
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Liège, Belgium, 4000
Novartis Investigative Site
Luxembourg, Belgium, 1210
Novartis Investigative Site
Oostende, Belgium, 8400
Novartis Investigative Site
Roeselare, Belgium, 8800
Novartis Investigative Site
Turnhout, Belgium, 2300
Novartis Investigative Site
Wavre, Belgium, 1301
Bulgaria
Novartis Investigative Site
Gabrovo, Bulgaria, 5300
Novartis Investigative Site
Pleven, Bulgaria, 5800
Novartis Investigative Site
Plovdiv, Bulgaria, 4002
Novartis Investigative Site
Ruse, Bulgaria, 7002
Novartis Investigative Site
Sofia, Bulgaria, 1431
Novartis Investigative Site
Stara Zagora, Bulgaria, 6000
Novartis Investigative Site
Troyan, Bulgaria, 5600
Novartis Investigative Site
Varna, Bulgaria, 9020
Canada, Alberta
Novartis Investigative Site
Calgary, Alberta, Canada, T2N 4n1
Canada, British Columbia
Novartis Investigative Site
Vancouver, British Columbia, Canada, V5Z 4E1
Canada, New Brunswick
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Moncton, New Brunswick, Canada, E1G 1A7
Canada, Ontario
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Burlington, Ontario, Canada, L7N 3V2
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Downsview, Ontario, Canada, M3N 2Z9
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Toronto, Ontario, Canada, M5T 3A9
Canada, Quebec
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Mirabel, Quebec, Canada, J7J 2K8
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Montreal, Quebec, Canada, H1M 1B1
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Montreal, Quebec, Canada, H3G 1L5
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Sherbrooke, Quebec, Canada, J1H 5N4
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St-Charles-Borromée, Quebec, Canada, J6E 2B4
Canada
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Quebec, Canada, G1N 4V3
Chile
Novartis Investigative Site
Quillota, Chile, 2260877
Novartis Investigative Site
Santiago, Chile, 8910131
Novartis Investigative Site
Santiago, Chile
China, Beijing
Novartis Investigative Site
Beijing, Beijing, China, 100023
Novartis Investigative Site
Beijing, Beijing, China, 100730
China, Guangdong
Novartis Investigative Site
Guang Zhou, Guangdong, China, 510120
China, Hainan
Novartis Investigative Site
Haikou, Hainan, China, 570311
China, Hebei
Novartis Investigative Site
Shijiazhuang, Hebei, China, 050000
China, Hunan
Novartis Investigative Site
Changsha, Hunan, China, 410003
China, Jiangsu
Novartis Investigative Site
Nanjing, Jiangsu, China, 210029
Novartis Investigative Site
Suzhou, Jiangsu, China, 215006
China, Jiangxi
Novartis Investigative Site
Nanchang, Jiangxi, China, 330006
China, Liaoning
Novartis Investigative Site
Shengyang, Liaoning, China, 110016
China, Shanghai
Novartis Investigative Site
Shanghai, Shanghai, China, 200433
China, Shanxi
Novartis Investigative Site
Xi'an, Shanxi, China, 710032
China, Sichuan
Novartis Investigative Site
Chengdu, Sichuan, China, 610041
China, Zhejiang
Novartis Investigative Site
Hangzhou, Zhejiang, China, 310006
China
Novartis Investigative Site
Beijing, China, 100050
Novartis Investigative Site
Chongqing, China, 400037
Novartis Investigative Site
Chongqing, China, 400038
Novartis Investigative Site
Guang Zhou, China, 510010
Novartis Investigative Site
Shanghai, China, 200025
Novartis Investigative Site
Tianjin, China, 300052
Colombia
Novartis Investigative Site
Bogota, Cundinamarca, Colombia
Novartis Investigative Site
Floridablanca, Santander, Colombia, 57-7
Novartis Investigative Site
Armenia, Colombia
Novartis Investigative Site
Medellín, Colombia
Croatia
Novartis Investigative Site
Karlovac, Croatia, 47000
Novartis Investigative Site
Zagreb, Croatia, 10 000
Novartis Investigative Site
Zagreb, Croatia, 10000
Czech Republic
Novartis Investigative Site
Benesov, Czech Republic, 256 30
Novartis Investigative Site
Cesky Krumlov, Czech Republic, 381 01
Novartis Investigative Site
Cvikov, Czech Republic, 471 54
Novartis Investigative Site
Jindrichuv Hradec III, Czech Republic, 377 01
Novartis Investigative Site
Liberec, Czech Republic, 460 01
Novartis Investigative Site
Melnik, Czech Republic, 267 01
Novartis Investigative Site
Olomouc, Czech Republic, 775 20
Novartis Investigative Site
Ostrava - Hrabuvka, Czech Republic, 70030
Novartis Investigative Site
Ostrava, Czech Republic, 708 68
Novartis Investigative Site
Pardubice, Czech Republic, 530 09
Novartis Investigative Site
Prague 4, Czech Republic, 142 00
Novartis Investigative Site
Praha 10, Czech Republic, 108 00
Novartis Investigative Site
Praha 5, Czech Republic, 158 00
Novartis Investigative Site
Praha 6 - Repy, Czech Republic, 163 00
Novartis Investigative Site
Praha 6, Czech Republic, 169 00
Novartis Investigative Site
Strakonice, Czech Republic, 38601
Novartis Investigative Site
Teplice, Czech Republic, 415 01
Novartis Investigative Site
Zatec, Czech Republic, 438 01
Denmark
Novartis Investigative Site
Aalborg, Denmark, DK-9000
Novartis Investigative Site
Copenhagen NV, Denmark, DK-2400
Novartis Investigative Site
Hellerup, Denmark, DK-2900
Novartis Investigative Site
Hvidovre, Denmark, DK-2650
Novartis Investigative Site
Næstved, Denmark, 4700
Novartis Investigative Site
Roskilde, Denmark, DK-4000
Novartis Investigative Site
Silkeborg, Denmark, 8600
Novartis Investigative Site
Sønderborg, Denmark, DK-6400
Novartis Investigative Site
Århus, Denmark, DK-8000
Estonia
Novartis Investigative Site
Tallinn, Estonia, 13419
Novartis Investigative Site
Tallinn, Estonia, 13619
Novartis Investigative Site
Tartu, Estonia, 51014
Finland
Novartis Investigative Site
Helsinki, Finland, 00290
Novartis Investigative Site
HUS, Finland, 00029
Novartis Investigative Site
Jyvaskyla, Finland, 40100
Novartis Investigative Site
Kuopio, Finland, FIN-70211
Novartis Investigative Site
Pori, Finland, FIN-28500
Novartis Investigative Site
Turku, Finland, FIN-20100
France
Novartis Investigative Site
Angers, France, 49000
Novartis Investigative Site
Beuvry, France, 62660
Novartis Investigative Site
Briis Sous Forges, France, 91640
Novartis Investigative Site
Cournonterral, France, 34660
Novartis Investigative Site
Lyon cedex 04, France, 69317
Novartis Investigative Site
Montpellier, France, 34059
Novartis Investigative Site
Nantes, France, 44000
Novartis Investigative Site
Nantes, France, 44300
Novartis Investigative Site
Nimes Cedex, France, 30029
Novartis Investigative Site
Pessac, France, 33604
Novartis Investigative Site
Reims, France, 51092
Novartis Investigative Site
St Genis des Fontaines, France, 66740
Germany
Novartis Investigative Site
Heidelberg, Baden-Württemberg, Germany, 69126
Novartis Investigative Site
Hannover, Niedersachsen, Germany, 30159
Novartis Investigative Site
Peine, Niedersachsen, Germany, 31224
Novartis Investigative Site
Koblenz, NRW, Germany, 56068
Novartis Investigative Site
Cottbus, Sachsen, Germany, 03050
Novartis Investigative Site
Geesthacht, Schleswig Holstein, Germany, 12502
Novartis Investigative Site
Aschaffenburg, Germany, 63739
Novartis Investigative Site
Bad Woerishofen, Germany, 86825
Novartis Investigative Site
Bamberg, Germany, 96049
Novartis Investigative Site
Berlin, Germany, 10117
Novartis Investigative Site
Berlin, Germany, 10119
Novartis Investigative Site
Berlin, Germany, 10367
Novartis Investigative Site
Berlin, Germany, 10789
Novartis Investigative Site
Berlin, Germany, 10969
Novartis Investigative Site
Berlin, Germany, 12043
Novartis Investigative Site
Berlin, Germany, 12099
Novartis Investigative Site
Berlin, Germany, 12203
Novartis Investigative Site
Berlin, Germany, 13086
Novartis Investigative Site
Berlin, Germany, 13156
Novartis Investigative Site
Berlin, Germany, 13581
Novartis Investigative Site
Bielefeld, Germany, 33617
Novartis Investigative Site
Bochum, Germany, 44787
Novartis Investigative Site
Bonn, Germany, 53119
Novartis Investigative Site
Bonn, Germany, 53123
Novartis Investigative Site
Delitzsch, Germany, 04509
Novartis Investigative Site
Dresden, Germany, 01307
Novartis Investigative Site
Duisburg, Germany, 47057
Novartis Investigative Site
Erlangen, Germany, 91052
Novartis Investigative Site
Frankfurt, Germany, 60389
Novartis Investigative Site
Frankfurt, Germany, 60596
Novartis Investigative Site
Freudenberg, Germany, 57258
Novartis Investigative Site
Gauting, Germany, 82131
Novartis Investigative Site
Hagen, Germany, 59065
Novartis Investigative Site
Halle, Germany, 06108
Novartis Investigative Site
Hamburg, Germany, 20253
Novartis Investigative Site
Hamburg, Germany, 20354
Novartis Investigative Site
Hamburg, Germany, 22299
Novartis Investigative Site
Hannover Münden, Germany, 34346
Novartis Investigative Site
Kassel, Germany, 34121
Novartis Investigative Site
Koeln, Germany, 51069
Novartis Investigative Site
Landsberg, Germany, 86899
Novartis Investigative Site
Leipzig, Germany, 04103
Novartis Investigative Site
Leipzig, Germany, 04207
Novartis Investigative Site
Leipzig, Germany, 04275
Novartis Investigative Site
Leipzig, Germany, 04357
Novartis Investigative Site
Lübeck, Germany, 23552
Novartis Investigative Site
Lübeck, Germany, 23558
Novartis Investigative Site
Marburg, Germany, 35037
Novartis Investigative Site
Minden, Germany, 32423
Novartis Investigative Site
München, Germany, 80335
Novartis Investigative Site
Neu Isenburg, Germany, 63263
Novartis Investigative Site
Neumünster, Germany, 24534
Novartis Investigative Site
Oranienburg, Germany, 16515
Novartis Investigative Site
Potsdam, Germany, 14467
Novartis Investigative Site
Potsdam, Germany, 14469
Novartis Investigative Site
Prien a. Chiemsee, Germany, 83209
Novartis Investigative Site
Ratingen, Germany, 40878
Novartis Investigative Site
Reinfeld, Germany, 23858
Novartis Investigative Site
Rüdersdorf, Germany, 15562
Novartis Investigative Site
Schleswig, Germany, 24837
Novartis Investigative Site
Schwabach, Germany, 91126
Novartis Investigative Site
Solingen, Germany, 42651
Novartis Investigative Site
Stade, Germany, 21680
Novartis Investigative Site
Teuchern, Germany, 06682
Novartis Investigative Site
Ulm, Germany, 89073
Novartis Investigative Site
Warendorf, Germany, 48231
Novartis Investigative Site
Weinheim, Germany, 69469
Novartis Investigative Site
Wissen, Germany, 57537
Novartis Investigative Site
Witten, Germany, 58452
Greece
Novartis Investigative Site
Athens, GR, Greece, 106 76
Novartis Investigative Site
Athens, GR, Greece, 115 27
Novartis Investigative Site
Larissa, GR, Greece, 411 10
Novartis Investigative Site
Rethymno, GR, Greece, 741 00
Novartis Investigative Site
Thessaloniki, GR, Greece, 564 03
Novartis Investigative Site
Athens, Greece, 12462
Novartis Investigative Site
Athens, Greece, GR 115 27
Novartis Investigative Site
Heraklion Crete, Greece, GR 711 10
Novartis Investigative Site
Serres, Greece, GR 62 100
Novartis Investigative Site
Thessaloniki, Greece, GR 570 10
Guatemala
Novartis Investigative Site
Ciudad, Gautemala, Guatemala, 01010
Novartis Investigative Site
Guatemala City, Guatemala, 01010
Novartis Investigative Site
Guatemala City, Guatemala, 01011
Hong Kong
Novartis Investigative Site
Kowloon, Hong Kong
Novartis Investigative Site
New Territories, Hong Kong
Hungary
Novartis Investigative Site
Budapest, Hungary, 1121
Novartis Investigative Site
Budapest, Hungary, 1125
Novartis Investigative Site
Budapest, Hungary, 1145
Novartis Investigative Site
Deszk, Hungary, 6772
Novartis Investigative Site
Komarom, Hungary, 2900
Novartis Investigative Site
Torokbalint, Hungary, 2045
Iceland
Novartis Investigative Site
Reykjavik, Iceland, IS-109
India
Novartis Investigative Site
Hyderabad, Andhra Pradesh, India, 500004
Novartis Investigative Site
Vijayawada, Andhra Pradesh, India, 520 002
Novartis Investigative Site
Vishakhapatnam, Andhra Pradesh, India, 530002
Novartis Investigative Site
Ahmedabad, Gujarat, India, 380 008
Novartis Investigative Site
Ahmedabad, Gujarat, India, 380 060
Novartis Investigative Site
Gurgaon, Haryana, India, 122 002
Novartis Investigative Site
Manipal, Karnataka, India, 576 104
Novartis Investigative Site
Nagpur, Maharashtra, India, 400 012
Novartis Investigative Site
Nagpur, Maharashtra, India, 440010
Novartis Investigative Site
Ludhiana, Punjab, India, 141001
Novartis Investigative Site
Chennai, Tamil Nadu, India, 641037
Novartis Investigative Site
Coimbatore, Tamil Nadu, India, 641 045.
Novartis Investigative Site
Coimbatore, Tamil Nadu, India, 641037
Novartis Investigative Site
Coimbatore, Tamilnadu, India, 641 018
Novartis Investigative Site
Kolkata, West Bengal, India, 700 107
Novartis Investigative Site
Bangalore, India, 560 034
Italy
Novartis Investigative Site
Ancona, AN, Italy, 60020
Novartis Investigative Site
Cassano delle Murge, BA, Italy, 70020
Novartis Investigative Site
Crema, CR, Italy, 26013
Novartis Investigative Site
Foggia, FG, Italy, 71100
Novartis Investigative Site
Firenze, FI, Italy, 50100
Novartis Investigative Site
Genova, GE, Italy, 16132
Novartis Investigative Site
Milano, MI, Italy, 20126
Novartis Investigative Site
Pavullo nel Frignano, MO, Italy, 41026
Novartis Investigative Site
Palermo, PA, Italy, 90146
Novartis Investigative Site
Cittadella, PD, Italy, 35013
Novartis Investigative Site
Pisa, PI, Italy, 56124
Novartis Investigative Site
Pordenone, PN, Italy, 33170
Novartis Investigative Site
Pavia, PV, Italy, 27100
Novartis Investigative Site
Reggio Emilia, RE, Italy, 42123
Novartis Investigative Site
Cuasso al Monte, VA, Italy, 21050
Novartis Investigative Site
Tradate, VA, Italy, 21049
Novartis Investigative Site
Negrar, VR, Italy, 37024
Novartis Investigative Site
Napoli, Italy, 80131
Japan
Novartis Investigative Site
Komaki-city, Aichi, Japan, 485-0041
Novartis Investigative Site
Nagoya, Aichi, Japan, 457-8511
Novartis Investigative Site
Seto-city, Aichi, Japan, 489-8642
Novartis Investigative Site
Toyoake-city, Aichi, Japan, 470-1192
Novartis Investigative Site
Fukuoka-city, Fukuoka, Japan, 811-1394
Novartis Investigative Site
Yanagawa-city, Fukuoka, Japan, 832-0059
Novartis Investigative Site
Asahikawa-city, Hokkaido, Japan, 070-8644
Novartis Investigative Site
Sapporo-city, Hokkaido, Japan, 060-8648
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 062-8618
Novartis Investigative Site
Himeji-city, Hyogo, Japan, 672-8064
Novartis Investigative Site
Sakaide-city, Kagawa, Japan, 762-8550
Novartis Investigative Site
Takamatsu, Kagawa, Japan, 760-8538
Novartis Investigative Site
Kawasaki-city, Kanagawa, Japan, 210-0852
Novartis Investigative Site
Koshi-city, Kumamoto, Japan, 861-1196
Novartis Investigative Site
Kyoto-city, Kyoto, Japan, 606-8507
Novartis Investigative Site
Matsusaka-city, Mie, Japan, 515-8544
Novartis Investigative Site
Sendai-city, Miyagi, Japan, 980-8574
Novartis Investigative Site
Kishiwada-city, Osaka, Japan, 596-8501
Novartis Investigative Site
Koshigaya-city, Saitama, Japan, 343-0851
Novartis Investigative Site
Hamamatsu, Shizuoka, Japan, 430-8525
Novartis Investigative Site
Hamamatsu, Shizuoka, Japan, 434-8511
Novartis Investigative Site
Iwata, Shizuoka, Japan, 438-8550
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan, 113-8431
Novartis Investigative Site
Chuo-ku, Tokyo, Japan, 103-0027
Novartis Investigative Site
Itabashi-ku, Tokyo, Japan, 173-8610
Novartis Investigative Site
Kiyose-city, Tokyo, Japan, 204-8585
Novartis Investigative Site
Meguro, Tokyo, Japan, 152-8902
Novartis Investigative Site
Fukuoka, Japan, 812-0033
Novartis Investigative Site
Kochi, Japan, 780-8077
Korea, Republic of
Novartis Investigative Site
Bucheon-Si, Gyeonggi-Do, Korea, Republic of, 14584
Novartis Investigative Site
Jeonju-si, Jeollabuk-do, Korea, Republic of, 561-712
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 03080
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 130-709
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 137-701
Novartis Investigative Site
Incheon, Korea, Republic of, 403-720
Novartis Investigative Site
Seoul, Korea, Republic of, 130-872
Novartis Investigative Site
Seoul, Korea, Republic of, 136-705
Novartis Investigative Site
Seoul, Korea, Republic of, 156-755
Latvia
Novartis Investigative Site
Riga, LV, Latvia, LV-1038
Novartis Investigative Site
Daugavpils, Latvia, LV-5401
Novartis Investigative Site
Riga, Latvia, 1002
Lithuania
Novartis Investigative Site
Kaunas, LTU, Lithuania, 50009
Novartis Investigative Site
Kaunas, LT, Lithuania, 50128
Novartis Investigative Site
Vilnius, LT, Lithuania, 01117
Novartis Investigative Site
Alytus, Lithuania, LT-62114
Novartis Investigative Site
Kaunas, Lithuania, LT-45130
Novartis Investigative Site
Klaipeda, Lithuania, 92288
Novartis Investigative Site
Klaipeda, Lithuania, LT-92231
Novartis Investigative Site
Vilnius, Lithuania, 06122
Novartis Investigative Site
Vilnius, Lithuania, LT-08661
Mexico
Novartis Investigative Site
Mexico, Distrito Federal, Mexico, 14050
Novartis Investigative Site
México, Distrito Federal, Mexico, 14080
Novartis Investigative Site
Guadalajara Jalisco, Jalisco, Mexico, 44220
Novartis Investigative Site
Zapopan, Jalisco, Mexico, 45200
Novartis Investigative Site
Aguascalientes, Mexico, 20230
Novartis Investigative Site
Mexico D.F., Mexico, 06726
Novartis Investigative Site
Puebla, Mexico, 72000
Netherlands
Novartis Investigative Site
Almelo, Netherlands, 7609 PP
Novartis Investigative Site
Assen, Netherlands, 9401 RK
Novartis Investigative Site
Breda, Netherlands, 4818 CK
Novartis Investigative Site
Eindhoven, Netherlands, 5623 EJ
Novartis Investigative Site
Enschede, Netherlands, 7513 ER
Novartis Investigative Site
Geldrop, Netherlands, 5664 EH
Novartis Investigative Site
Groningen, Netherlands, 9728 NT
Novartis Investigative Site
Harderwijk, Netherlands, 3840 AC
Novartis Investigative Site
Zutphen, Netherlands, 7207 AE
Norway
Novartis Investigative Site
Follebu, Norway, 2656
Novartis Investigative Site
Hønefoss, Norway, 3515
Novartis Investigative Site
Kløfta, Norway, 2040
Novartis Investigative Site
Kongsvinger, Norway, 2212
Novartis Investigative Site
Skedsmokorset, Norway, 2020
Novartis Investigative Site
Stavanger, Norway, 4005
Novartis Investigative Site
Svelvik, Norway, 3060
Novartis Investigative Site
Trondheim, Norway, 7006
Philippines
Novartis Investigative Site
Lipa City, Batangas, Philippines, 4217
Novartis Investigative Site
Bulacan, Philippines, 3020
Novartis Investigative Site
Quezon City, Philippines, 1100
Poland
Novartis Investigative Site
Bialystok, Poland, 15-010
Novartis Investigative Site
Bialystok, Poland, 15-044
Novartis Investigative Site
Lodz, Poland, 90-153
Novartis Investigative Site
Pila, Poland, 64-920
Novartis Investigative Site
Poznan, Poland, 60-569
Novartis Investigative Site
Sopot, Poland, 81-741
Novartis Investigative Site
Wroclaw, Poland, 51-162
Portugal
Novartis Investigative Site
Almada, Portugal, 2801-951
Novartis Investigative Site
Barcelos, Portugal, 4754-909
Novartis Investigative Site
Braga, Portugal, 4710-243
Novartis Investigative Site
Coimbra, Portugal, 3041-853
Novartis Investigative Site
Lisboa, Portugal, 1169-024
Novartis Investigative Site
Lisboa, Portugal, 1769-001
Novartis Investigative Site
Porto, Portugal, 4200-319
Novartis Investigative Site
Torres Vedras, Portugal, 2560-324
Novartis Investigative Site
Vila Franca de Xira, Portugal, 2600-009
Novartis Investigative Site
Vila Nova de Gaia, Portugal, 4434-502
Novartis Investigative Site
Viseu, Portugal, 3504-509
Romania
Novartis Investigative Site
Bucuresti, District 1, Romania, 10457
Novartis Investigative Site
Bucharest, District 3, Romania, 030317
Novartis Investigative Site
Craiova, Dolj, Romania, 200515
Novartis Investigative Site
Iasi, Jud. Iasi, Romania, 700115
Novartis Investigative Site
Timisoara, Timis, Romania, 300310
Novartis Investigative Site
Arad, Romania, 310013
Novartis Investigative Site
Arad, Romania, 310086
Novartis Investigative Site
Brasov, Romania, 500086
Novartis Investigative Site
Bucharest, Romania, 050159
Novartis Investigative Site
Bucharest, Romania, 060011
Novartis Investigative Site
Bucharest, Romania
Novartis Investigative Site
Bucuresti, Romania, 50159
Novartis Investigative Site
Cluj-Napoca, Romania, 400371
Novartis Investigative Site
Deva, Romania, 330084
Novartis Investigative Site
Deva, Romania, 330162
Novartis Investigative Site
Iasi, Romania, 700305
Novartis Investigative Site
Oradea, Romania, 410051
Novartis Investigative Site
Targu Mures, Romania, 540072
Russian Federation
Novartis Investigative Site
Barnaul, Russian Federation, 656045
Novartis Investigative Site
Chelyabinsk, Russian Federation, 454021
Novartis Investigative Site
Kazan, Russian Federation, 420012
Novartis Investigative Site
N.Novgorod, Russian Federation, 603126
Novartis Investigative Site
Rostov-on-Don, Russian Federation, 344090
Novartis Investigative Site
Ryazan, Russian Federation, 390026
Novartis Investigative Site
Saratov, Russian Federation, 410012
Novartis Investigative Site
Tver, Russian Federation, 170100
Novartis Investigative Site
Ufa, Russian Federation, 450000
Novartis Investigative Site
Yaroslavl, Russian Federation, 150030
Serbia
Novartis Investigative Site
Belgrade, Serbia, 11000
Novartis Investigative Site
Belgrade, Serbia, 11080
Novartis Investigative Site
Knez Selo, Serbia, 18204
Novartis Investigative Site
Kragujevac, Serbia, 34000
Slovakia
Novartis Investigative Site
Bardejov, Slovak Republic, Slovakia, 085 01
Novartis Investigative Site
Bojnice, Slovak Republic, Slovakia, 972 01
Novartis Investigative Site
Humenné, Slovak republic, Slovakia, 066 01
Novartis Investigative Site
Kosice, Slovak republic, Slovakia, 04001
Novartis Investigative Site
Liptovsky Hradok, Slovak Republic, Slovakia, 033 01
Novartis Investigative Site
Partizanske, Slovak Republic, Slovakia, 958 01
Novartis Investigative Site
Námestovo, Slovensko, Slovakia, 02901
Novartis Investigative Site
Bratislava, Slovakia, 84104
Novartis Investigative Site
Kosice, Slovakia, 040 01
Novartis Investigative Site
Lucenec, Slovakia, 98439
Novartis Investigative Site
Martin, Slovakia, 036 59
Novartis Investigative Site
Nove Zamky, Slovakia, 940 01
Novartis Investigative Site
Poprad, Slovakia, 058 01
Novartis Investigative Site
Povazska Bystrica, Slovakia, 017 01
Novartis Investigative Site
Spisská Nová Ves, Slovakia, 052 01
South Africa
Novartis Investigative Site
Berea, Durban, South Africa, 4001
Novartis Investigative Site
Sandton, Gauteng, South Africa, 2057
Novartis Investigative Site
Cape Town, South Africa, 7500
Novartis Investigative Site
Cape Town, South Africa, 7505
Novartis Investigative Site
Cape Town, South Africa, 7531
Novartis Investigative Site
Cape Town, South Africa, 7925
Novartis Investigative Site
Gatesville, South Africa, 7764
Novartis Investigative Site
Port Elizabeth, South Africa, 6014
Novartis Investigative Site
Pretoria, South Africa, 0132
Novartis Investigative Site
Pretoria, South Africa, 0181
Spain
Novartis Investigative Site
Cordoba, Andalucia, Spain, 14004
Novartis Investigative Site
Malaga, Andalucia, Spain, 29010
Novartis Investigative Site
Sanlucar de Barrameda, Andalucia, Spain, 11540
Novartis Investigative Site
Oviedo, Asturias, Spain, 33006
Novartis Investigative Site
Torrelavega, Cantabria, Spain, 39300
Novartis Investigative Site
Burgos, Castilla y Leon, Spain, 09006
Novartis Investigative Site
Ponferrada, Castilla y Leon, Spain, 24400
Novartis Investigative Site
Valladolid, Castilla y Leon, Spain, 47011
Novartis Investigative Site
Barcelona, Cataluna, Spain, 08026
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08003
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site
Barcelona, Cataluña, Spain, 08024
Novartis Investigative Site
Salt, Cataluña, Spain, 17190
Novartis Investigative Site
Alicante, Comunidad Valenciana, Spain, 03550
Novartis Investigative Site
Alzira, Comunidad Valenciana, Spain, 46600
Novartis Investigative Site
Valencia, Comunidad Valenciana, Spain, 46014
Novartis Investigative Site
Merida, Extremadura, Spain, 06800
Novartis Investigative Site
Pozuelo de Alarcón, Madrid, Spain, 28223
Novartis Investigative Site
Cartagena, Murcia, Spain, 30202
Novartis Investigative Site
Baracaldo, Vizcaya, Spain, 48903
Novartis Investigative Site
Barcelona, Spain, 08022
Novartis Investigative Site
Madrid, Spain, 28029
Novartis Investigative Site
Madrid, Spain, 28046
Sweden
Novartis Investigative Site
Boras, Sweden, 506 30
Novartis Investigative Site
Luleå, Sweden, SE-971 80
Novartis Investigative Site
Lund, Sweden, SE-221 85
Novartis Investigative Site
Stockholm, Sweden, 111 57
Novartis Investigative Site
Trollhattan, Sweden, 461 85
Novartis Investigative Site
Uddevalla, Sweden, 451 50
Taiwan
Novartis Investigative Site
Tainan 704, Taiwan ROC, Taiwan
Novartis Investigative Site
Chiayi County, Taiwan, 613
Novartis Investigative Site
Niaosong Township, Taiwan, 83301
Novartis Investigative Site
Taichung, Taiwan, 40447
Novartis Investigative Site
Taichung, Taiwan, 40705
Novartis Investigative Site
Taipei County, Taiwan, 22060
Novartis Investigative Site
Taipei, Taiwan, 10002
Novartis Investigative Site
Taipei, Taiwan, 112
Thailand
Novartis Investigative Site
Bangkok, Thailand, 10700
Novartis Investigative Site
Chiang Mai, Thailand, 50200
Novartis Investigative Site
Khon Kaen, Thailand, 40002
Novartis Investigative Site
Songkla, Thailand, 90110
Turkey
Novartis Investigative Site
Ankara, Turkey, 06100
Novartis Investigative Site
Ankara, Turkey, 06490
Novartis Investigative Site
Istanbul, Turkey, 34854
Novartis Investigative Site
Istanbul, Turkey
Novartis Investigative Site
Izmir, Turkey, 35040
Novartis Investigative Site
Kinikli / Denizli, Turkey, 20070
Novartis Investigative Site
Manisa, Turkey, 45040
Novartis Investigative Site
Mersin, Turkey, 33079
United Kingdom
Novartis Investigative Site
Huntingdon, Cambridgeshire, United Kingdom, PE29 6NT
Novartis Investigative Site
Stockton, Cleveland, United Kingdom, TS19 8PE
Novartis Investigative Site
Midsomer Norton, Radstock, United Kingdom, BA3 2UH
Novartis Investigative Site
Axbridge, Somerset, United Kingdom, BS26 2BJ
Novartis Investigative Site
Taunton, Somerset, United Kingdom, TA1 5DA
Novartis Investigative Site
South Shields, Tyne and Wear, United Kingdom, NE34 0PL
Novartis Investigative Site
Crawley, West Sussex, United Kingdom, RH10 7DX
Novartis Investigative Site
Bradford, West Yorkshire, United Kingdom, BD9 6RJ
Novartis Investigative Site
Birmingham, United Kingdom, B15 2TH
Novartis Investigative Site
Cambridge, United Kingdom, CB7 5JD
Novartis Investigative Site
Chester, United Kingdom, CH2 1UL
Novartis Investigative Site
Darlington, United Kingdom, DL3 6HX
Novartis Investigative Site
Lancashire, United Kingdom, FY3 7EN
Novartis Investigative Site
Leeds, United Kingdom, LS9 7TF
Novartis Investigative Site
London, United Kingdom, EC14 7BE
Novartis Investigative Site
Newcastle-upon-Tyne, United Kingdom, NE7 7DN
Novartis Investigative Site
Southampton, United Kingdom, SO16 6YD
Novartis Investigative Site
Tyne & Wear, United Kingdom, NE29 8NH
Novartis Investigative Site
Wiltshire, United Kingdom, SN15 2SB
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01782326     History of Changes
Other Study ID Numbers: CQVA149A2318 
Study First Received: January 30, 2013
Results First Received: May 4, 2016
Last Updated: May 5, 2016
Health Authority: European Union: European Medicines Agency

Keywords provided by Novartis:
COPD, QVA149, FLAME( EFfect of Indacaterol Glycopyronium Vs Fluticasone salmeterol on COPD Exacerbations)

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Fluticasone
Salmeterol Xinafoate
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Glycopyrrolate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 27, 2016