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Comparison of Long-term Safety of the Combination Product QVA149A Against Placebo and Standard of Care Treatment in Chronic Obstructive Pulmonary Disease Patients With Moderate to Severe Airflow Limitation

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
QVA149
Tiotropium
placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring chronic obstructive pulmonary disease, COPD, QVA149, QAB149, NVA237, Indacaterol maleate, Glycopyronnium bromide

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Male and female adults aged ≥40 years.
  • Patients with stable COPD according to GOLD strategy (GOLD 2011).
  • Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥ 30% and <80% of the predicted normal, and a post-bronchodilator.
  • FEV1/FVC < 0.70.
  • Current or ex-smokers who have a smoking history of at least 10 pack years.
  • Patients with an mMRC ≥ grade 2

Exclusion criteria:

  • History of long QT syndrome or prolonged QTc.
  • 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 Visit 1.
  • Patients with Type I or uncontrolled Type II diabetes.
  • Patients with a history of asthma or have concomitant pulmonary disease.
  • Patients with paroxysmal (e.g. intermittent) atrial fibrillation. Only patients with persistent atrial fibrillation and controlled with a rate control strategy for at least six months could be eligible.
  • Patients who have clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of safety.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

QVA149

Tiotropium

placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of Patients With Serious Adverse Events
The overall rate of serious adverse events reported from initiation through 30 days post last dose.

Secondary Outcome Measures

Percentage of Patients With Composite Endpoint of All-cause Mortality, and Serious Cardio- and Cerebrovascular (CCV) Events.
The endpoint of all-cause mortality and serious CCV events (composite) was chosen to further characterize any discernible risks. The patients with an event in the analysis were those who had at least one of the 2 events namely, all-cause mortality and serious CCV, during treatment or within 30 days after the date of last dose of study drug.
Post-hoc Analysis: Percentage of Patients With Composite Endpoint of Cardiovascular Death and MACE
The composite endpoint included all deaths and all serious CCV events, including MACE and events which were not considered MACE. A rigorous post hoc analysis was done on composite endpoint of CV deaths and major adverse cardiovascular events (MACE). The patients with an event in the analysis were those who had at least one of the 2 events namely, CV deaths and MACE, during treatment or within 30 days after the date of last dose of study drug.
Change From Baseline in Pre-Dose Forced Expiratory Volume Over in Second (FEV1)
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.
Change From Baseline in Health Status as Measured by St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C)
The SGRQ-C contains 40 items divided into two parts covering three aspects of health related to COPD: Part I covers "Symptoms" and is concerned with respiratory symptoms, their frequency and severity; Part II covers "Activity" and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with "Impacts" which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score will be calculated for each of these three subscales and a "Total" score will also be calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status.
Change From Baseline in Daily, Morning and Evening Symptom Scores
Patients will be provided with an electronic diary (eDiary) to record daily clinical symptoms, or rescue medication. The patients will be instructed to routinely complete the patient diary twice daily. There are 9 total symptom questions for a total possible score of 27 at each timepoint. A higher score means the patient is reporting more symptoms related to Chronic Obstructive Pulmonary Disease. The mean daily total symptom score, the mean daytime total symptom score and the mean nighttime total symptom score were calculated for each patient over 52 weeks. Diary data recorded during the 14 day run-in period were used to calculate the baseline.
Change From Baseline in Percentage of Nights With 'no Nighttime Awakenings
A night with 'no nighttime awakenings' is defined from diary data as any night where the patient did not wake up due to symptoms.
Change From Baseline in Percentage of no Daytime Symptoms
A day with 'no daytime symptoms' is defined from the diary data as any day where the patient has recorded in the evening no cough, no wheeze, no production of sputum and no feeling of breathlessness (other than when running) during the past 12 hours (approx. 8 am to 8 pm).
Change From Baseline in Percentage of Days Able to Perform Usual Daily Activities.
A day able to perform usual daily activities' is defined from diary data as any day where the patient was not prevented from performing their usual daily activities due to respiratory symptoms.
Change From Baseline in 1 Hour Post-dose Forced Vital Capacity (FVC) Measurements
Pulmonary function assessments were performed using centralized spirometry according to international standards
Time to Premature Discontinuation
Time to premature treatment discontinuation for each treatment group was displayed using a Kaplan-Meier curve. The date of last dose of study medication was considered as the event date and also as the censoring date for those patients who did not discontinue treatment early. The range of the 'time to treatment discontinuation' varied from 5-407 days in the Tiotropium group. Hence the model estimated lower limit of the median time to treatment discontinuation is greater than the scheduled treatment period of 52 weeks.
Change From Baseline in 1 Hour Post-dose FEV1 Measurements
The avg 60 min post dose forced expiratory volume in 1 second (FEV1) at visit 4, 5, 6, 7, 8 and 9 will be analyzed.

Full Information

First Posted
May 30, 2012
Last Updated
May 9, 2016
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01610037
Brief Title
Comparison of Long-term Safety of the Combination Product QVA149A Against Placebo and Standard of Care Treatment in Chronic Obstructive Pulmonary Disease Patients With Moderate to Severe Airflow Limitation
Official Title
A Placebo and Active Controlled Study to Assess the Long-term Safety of Once Daily QVA149 for 52 Weeks in Chronic Obstructive Pulmonary Disease (COPD) Patients With Moderate to Severe Airflow Limitation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study will assess the long-term safety of the fixed combination product QVA149 versus placebo and a standard of care treatment (tiotropium) in Chronic Obstructive Pulmonary Disease (COPD) patients with moderate to severe airflow limitation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
chronic obstructive pulmonary disease, COPD, QVA149, QAB149, NVA237, Indacaterol maleate, Glycopyronnium bromide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
QVA149
Arm Type
Experimental
Arm Title
Tiotropium
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
QVA149
Intervention Description
QVA149 110/50 µg will be supplied as capsules in blister packs for once daily inhalation using the Novartis Concept1 SDDPI
Intervention Type
Drug
Intervention Name(s)
Tiotropium
Intervention Description
Tiotropium 18 µg will be supplied as capsules in blister packs for once daily inhalation using the HandiHaler SDDPI
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo to QVA149A and Tiotropium will be supplied in the appropriate capsule in blister packs for use in either the Novartis Concept1 SDDPI or the HandiHaler SDDPI
Primary Outcome Measure Information:
Title
Number of Patients With Serious Adverse Events
Description
The overall rate of serious adverse events reported from initiation through 30 days post last dose.
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Percentage of Patients With Composite Endpoint of All-cause Mortality, and Serious Cardio- and Cerebrovascular (CCV) Events.
Description
The endpoint of all-cause mortality and serious CCV events (composite) was chosen to further characterize any discernible risks. The patients with an event in the analysis were those who had at least one of the 2 events namely, all-cause mortality and serious CCV, during treatment or within 30 days after the date of last dose of study drug.
Time Frame
52 weeks
Title
Post-hoc Analysis: Percentage of Patients With Composite Endpoint of Cardiovascular Death and MACE
Description
The composite endpoint included all deaths and all serious CCV events, including MACE and events which were not considered MACE. A rigorous post hoc analysis was done on composite endpoint of CV deaths and major adverse cardiovascular events (MACE). The patients with an event in the analysis were those who had at least one of the 2 events namely, CV deaths and MACE, during treatment or within 30 days after the date of last dose of study drug.
Time Frame
52 weeks
Title
Change From Baseline in Pre-Dose Forced Expiratory Volume Over in Second (FEV1)
Description
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.
Time Frame
Day 22, 43, 85, 183, 274 and 364
Title
Change From Baseline in Health Status as Measured by St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C)
Description
The SGRQ-C contains 40 items divided into two parts covering three aspects of health related to COPD: Part I covers "Symptoms" and is concerned with respiratory symptoms, their frequency and severity; Part II covers "Activity" and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with "Impacts" which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score will be calculated for each of these three subscales and a "Total" score will also be calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status.
Time Frame
Measurment at day 364
Title
Change From Baseline in Daily, Morning and Evening Symptom Scores
Description
Patients will be provided with an electronic diary (eDiary) to record daily clinical symptoms, or rescue medication. The patients will be instructed to routinely complete the patient diary twice daily. There are 9 total symptom questions for a total possible score of 27 at each timepoint. A higher score means the patient is reporting more symptoms related to Chronic Obstructive Pulmonary Disease. The mean daily total symptom score, the mean daytime total symptom score and the mean nighttime total symptom score were calculated for each patient over 52 weeks. Diary data recorded during the 14 day run-in period were used to calculate the baseline.
Time Frame
52 weeks
Title
Change From Baseline in Percentage of Nights With 'no Nighttime Awakenings
Description
A night with 'no nighttime awakenings' is defined from diary data as any night where the patient did not wake up due to symptoms.
Time Frame
52 weeks
Title
Change From Baseline in Percentage of no Daytime Symptoms
Description
A day with 'no daytime symptoms' is defined from the diary data as any day where the patient has recorded in the evening no cough, no wheeze, no production of sputum and no feeling of breathlessness (other than when running) during the past 12 hours (approx. 8 am to 8 pm).
Time Frame
52 weeks
Title
Change From Baseline in Percentage of Days Able to Perform Usual Daily Activities.
Description
A day able to perform usual daily activities' is defined from diary data as any day where the patient was not prevented from performing their usual daily activities due to respiratory symptoms.
Time Frame
52 weeks
Title
Change From Baseline in 1 Hour Post-dose Forced Vital Capacity (FVC) Measurements
Description
Pulmonary function assessments were performed using centralized spirometry according to international standards
Time Frame
Day 1, 22, 43, 85, 183, 274 and 364
Title
Time to Premature Discontinuation
Description
Time to premature treatment discontinuation for each treatment group was displayed using a Kaplan-Meier curve. The date of last dose of study medication was considered as the event date and also as the censoring date for those patients who did not discontinue treatment early. The range of the 'time to treatment discontinuation' varied from 5-407 days in the Tiotropium group. Hence the model estimated lower limit of the median time to treatment discontinuation is greater than the scheduled treatment period of 52 weeks.
Time Frame
Time varied from 5 - 407 days
Title
Change From Baseline in 1 Hour Post-dose FEV1 Measurements
Description
The avg 60 min post dose forced expiratory volume in 1 second (FEV1) at visit 4, 5, 6, 7, 8 and 9 will be analyzed.
Time Frame
Day 1, 22, 43, 85, 183, 274 and 364

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Male and female adults aged ≥40 years. Patients with stable COPD according to GOLD strategy (GOLD 2011). Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥ 30% and <80% of the predicted normal, and a post-bronchodilator. FEV1/FVC < 0.70. Current or ex-smokers who have a smoking history of at least 10 pack years. Patients with an mMRC ≥ grade 2 Exclusion criteria: History of long QT syndrome or prolonged QTc. 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 Visit 1. Patients with Type I or uncontrolled Type II diabetes. Patients with a history of asthma or have concomitant pulmonary disease. Patients with paroxysmal (e.g. intermittent) atrial fibrillation. Only patients with persistent atrial fibrillation and controlled with a rate control strategy for at least six months could be eligible. Patients who have clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of safety.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
1028
Country
Argentina
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1113AAC
Country
Argentina
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1122AAK
Country
Argentina
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1180AAX
Country
Argentina
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1425AUA
Country
Argentina
Facility Name
Novartis Investigative Site
City
Florencio Varela
State/Province
Buenos Aires
ZIP/Postal Code
B2705XAE
Country
Argentina
Facility Name
Novartis Investigative Site
City
Florida
State/Province
Buenos Aires
ZIP/Postal Code
B1602DQD
Country
Argentina
Facility Name
Novartis Investigative Site
City
Lanus
State/Province
Buenos Aires
ZIP/Postal Code
B8000XAV
Country
Argentina
Facility Name
Novartis Investigative Site
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
B7600FZN
Country
Argentina
Facility Name
Novartis Investigative Site
City
Quilmes
State/Province
Buenos Aires
ZIP/Postal Code
B1878FNR
Country
Argentina
Facility Name
Novartis Investigative Site
City
San Isidro
State/Province
Buenos Aires
ZIP/Postal Code
B1642DCD
Country
Argentina
Facility Name
Novartis Investigative Site
City
Vicente Lopez
State/Province
Buenos Aires
ZIP/Postal Code
B1638AAI
Country
Argentina
Facility Name
Novartis Investigative Site
City
Concepcion del Uruguay
State/Province
Entre Rios
ZIP/Postal Code
E3260EPD
Country
Argentina
Facility Name
Novartis Investigative Site
City
Santa Fe
State/Province
Rosario
ZIP/Postal Code
S2000DBS
Country
Argentina
Facility Name
Novartis Investigative Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000AII
Country
Argentina
Facility Name
Novartis Investigative Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000CXH
Country
Argentina
Facility Name
Novartis Investigative Site
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
B1842DID
Country
Argentina
Facility Name
Novartis Investigative Site
City
Corrientes
ZIP/Postal Code
W3400
Country
Argentina
Facility Name
Novartis Investigative Site
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Facility Name
Novartis Investigative Site
City
Mendoza
ZIP/Postal Code
M5500CBA
Country
Argentina
Facility Name
Novartis Investigative Site
City
Salta
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Novartis Investigative Site
City
Santa Fe
ZIP/Postal Code
S3000FIL
Country
Argentina
Facility Name
Novartis Investigative Site
City
Santa Fe
ZIP/Postal Code
S3000FWO
Country
Argentina
Facility Name
Novartis Investigative Site
City
Bogota
State/Province
Cundinamarca
Country
Colombia
Facility Name
Novartis Investigative Site
City
Armenia
Country
Colombia
Facility Name
Novartis Investigative Site
City
Barranquilla
Country
Colombia
Facility Name
Novartis Investigative Site
City
Bogota
Country
Colombia
Facility Name
Novartis Investigative Site
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Novartis Investigative Site
City
Sisak
ZIP/Postal Code
44000
Country
Croatia
Facility Name
Novartis Investigative Site
City
Zagreb
ZIP/Postal Code
10 000
Country
Croatia
Facility Name
Novartis Investigative Site
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Novartis Investigative Site
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Novartis Investigative Site
City
Tallinn
ZIP/Postal Code
13619
Country
Estonia
Facility Name
Novartis Investigative Site
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Novartis Investigative Site
City
Budapest
State/Province
HUN
ZIP/Postal Code
1204
Country
Hungary
Facility Name
Novartis Investigative Site
City
Cegled
ZIP/Postal Code
2700
Country
Hungary
Facility Name
Novartis Investigative Site
City
Csorna
ZIP/Postal Code
H-9300
Country
Hungary
Facility Name
Novartis Investigative Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Novartis Investigative Site
City
Eger
ZIP/Postal Code
3300
Country
Hungary
Facility Name
Novartis Investigative Site
City
Erd
ZIP/Postal Code
H-2030
Country
Hungary
Facility Name
Novartis Investigative Site
City
Godollo
ZIP/Postal Code
2100
Country
Hungary
Facility Name
Novartis Investigative Site
City
Monor
ZIP/Postal Code
2200
Country
Hungary
Facility Name
Novartis Investigative Site
City
Mosonmagyarovar
ZIP/Postal Code
9200
Country
Hungary
Facility Name
Novartis Investigative Site
City
Siofok
ZIP/Postal Code
8600
Country
Hungary
Facility Name
Novartis Investigative Site
City
Szarvas
ZIP/Postal Code
5540
Country
Hungary
Facility Name
Novartis Investigative Site
City
Hyderabad
State/Province
A.p.
ZIP/Postal Code
500 001
Country
India
Facility Name
Novartis Investigative Site
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500004
Country
India
Facility Name
Novartis Investigative Site
City
Panjim
State/Province
Goa
ZIP/Postal Code
403 002
Country
India
Facility Name
Novartis Investigative Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560002
Country
India
Facility Name
Novartis Investigative Site
City
Mysore
State/Province
Karnataka
ZIP/Postal Code
570004
Country
India
Facility Name
Novartis Investigative Site
City
Trivandrum
State/Province
Kerala
ZIP/Postal Code
695 011
Country
India
Facility Name
Novartis Investigative Site
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440033
Country
India
Facility Name
Novartis Investigative Site
City
Bikaner
State/Province
Rajasthan
ZIP/Postal Code
334 001
Country
India
Facility Name
Novartis Investigative Site
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302 039
Country
India
Facility Name
Novartis Investigative Site
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302023
Country
India
Facility Name
Novartis Investigative Site
City
Coimbatore
State/Province
Tamil Nadu
ZIP/Postal Code
641 045.
Country
India
Facility Name
Novartis Investigative Site
City
Vellore
State/Province
Tamil Nadu
ZIP/Postal Code
632004
Country
India
Facility Name
Novartis Investigative Site
City
Ahmedabad
ZIP/Postal Code
380009
Country
India
Facility Name
Novartis Investigative Site
City
Nagpur - Maharashtra
ZIP/Postal Code
440012
Country
India
Facility Name
Novartis Investigative Site
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Novartis Investigative Site
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Novartis Investigative Site
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Novartis Investigative Site
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Novartis Investigative Site
City
Bucheon-Si
State/Province
Gyeonggi-Do
ZIP/Postal Code
14584
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
130-709
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Daegu
ZIP/Postal Code
705-703
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Incheon
ZIP/Postal Code
403-720
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
130-872
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
156-755
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Daugavpils
ZIP/Postal Code
LV-5401
Country
Latvia
Facility Name
Novartis Investigative Site
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Novartis Investigative Site
City
Riga
ZIP/Postal Code
LV-1038
Country
Latvia
Facility Name
Novartis Investigative Site
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06726
Country
Mexico
Facility Name
Novartis Investigative Site
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
14050
Country
Mexico
Facility Name
Novartis Investigative Site
City
León
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Novartis Investigative Site
City
Pachuca
State/Province
Hidalgo
ZIP/Postal Code
42090
Country
Mexico
Facility Name
Novartis Investigative Site
City
Panama City
State/Province
Panamá
ZIP/Postal Code
0834-00363
Country
Panama
Facility Name
Novartis Investigative Site
City
Panama City
State/Province
Panamá
Country
Panama
Facility Name
Novartis Investigative Site
City
Bialystok
ZIP/Postal Code
15-044
Country
Poland
Facility Name
Novartis Investigative Site
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
Novartis Investigative Site
City
Krakow
ZIP/Postal Code
31-159
Country
Poland
Facility Name
Novartis Investigative Site
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Novartis Investigative Site
City
Lodz
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
115280
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
125315
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
N.Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Nizhny Novgorod
ZIP/Postal Code
603018
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Saratov
ZIP/Postal Code
410012
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St-Petersburg
ZIP/Postal Code
193312
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St.-Petersburg
ZIP/Postal Code
193231
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Knez Selo
ZIP/Postal Code
18204
Country
Serbia
Facility Name
Novartis Investigative Site
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Novartis Investigative Site
City
Golnik
ZIP/Postal Code
4204
Country
Slovenia
Facility Name
Novartis Investigative Site
City
Kartal
ZIP/Postal Code
34890
Country
Turkey
Facility Name
Novartis Investigative Site
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Novartis Investigative Site
City
Mersin
ZIP/Postal Code
33079
Country
Turkey
Facility Name
Novartis Investigative Site
City
Pendik / Istanbul
ZIP/Postal Code
1330
Country
Turkey
Facility Name
Novartis Investigative Site
City
Yenisehir/Izmir
ZIP/Postal Code
35110
Country
Turkey
Facility Name
Novartis Investigative Site
City
Leamington Spa
State/Province
Warwickshire
ZIP/Postal Code
CV32 4RA
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Bradford
State/Province
West Yorkshire
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Birmingham
ZIP/Postal Code
B15 2WB
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Cheshire
ZIP/Postal Code
CW1 4QJ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Doncaster
ZIP/Postal Code
DN2 5LT
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Merseyside
ZIP/Postal Code
CH49 5PE
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Newport
ZIP/Postal Code
P030 5TG
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Portsmouth
ZIP/Postal Code
PO6 3AD
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Comparison of Long-term Safety of the Combination Product QVA149A Against Placebo and Standard of Care Treatment in Chronic Obstructive Pulmonary Disease Patients With Moderate to Severe Airflow Limitation

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