Back to resultsA Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB149 in Patients With COPD Who Have Moderate to Severe Airflow Limitation
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
QVA149
QVA149
QAB149
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, QAB149, QVA149, indacaterol maleate, gylcopyrronium bromide
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
- Other protocol defined inclusion/exclusion criteria may apply
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
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- 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
Experimental
Active Comparator
Arm Label
QVA149 dose 1
QVA149 dose 2
QAB149
Arm Description
QVA149 27.5/12.5 μg capsules
QVA149 27.5/25 μg capsules
QAB149 75 μg capsules
Outcomes
Primary Outcome Measures
Number of Patients With Adverse Events, Serious Adverse Events, and Death
The overall rate of adverse events reported from initiation through 30 days post last dose.
Secondary Outcome Measures
Time to Premature Discontinuation of Treatment
methodTime 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 earl
Change From Baseline in Pre-dose Trough 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. 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.
Change From Baseline in 1 Hour Post-dose FEV1 Measurements
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.
Change From Baseline in FVC Measurement at All Post-baseline Time Points
Pulmonary function assessments were performed using centralized spirometry according to international standards.
Percentage of Participants Experiencing Moderate or Severe COPD Exacerbation
Percentage of participants experiencing moderate or severe Chronic Obstructive Pulmonary Disease (COPD)
Change From Baseline in Mean Total Daily Symptom Scores
The participant recorded symptom scores twice daily in the eDiary. The daily clinical symptoms included: cough, wheezing, shortness of breath, sputum volume, sputum color, and night time awakening. The range of scores for each assessment is 0 to 3 where 0 indications No symptom and 3 indicates a Severe symptom. The maximum daytime total score is 27 and the maximum nighttime total score is 27. The total daily symptom score is obtained by adding the scores for the morning and evening symptoms for each day. The maximum possible total daily score is 54. A negative change from baseline indicated improvement.
Change From Baseline in the Daily Number of Puffs of Rescue Medication Over the 52 Week Period
Participants completed an electronic diary (eDiary) twice daily at the same time in the morning and evening to record the number of puffs of rescue medication taken in the previous 12 hours.
Full Information
NCT ID
NCT01682863
First Posted
September 7, 2012
Last Updated
February 29, 2016
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01682863
Brief Title
A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB149 in Patients With COPD Who Have Moderate to Severe Airflow Limitation
Official Title
A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB149 in Patients With COPD Who Have Moderate to Severe Airflow Limitation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (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
This study is to assess the safety and tolerability of two different doses of QVA149 and QAB149 in 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
COPD, QAB149, QVA149, indacaterol maleate, gylcopyrronium bromide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
614 (Actual)
8. Arms, Groups, and Interventions
Arm Title
QVA149 dose 1
Arm Type
Experimental
Arm Description
QVA149 27.5/12.5 μg capsules
Arm Title
QVA149 dose 2
Arm Type
Experimental
Arm Description
QVA149 27.5/25 μg capsules
Arm Title
QAB149
Arm Type
Active Comparator
Arm Description
QAB149 75 μg capsules
Intervention Type
Drug
Intervention Name(s)
QVA149
Intervention Description
QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI
Intervention Type
Drug
Intervention Name(s)
QVA149
Intervention Description
QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI
Intervention Type
Drug
Intervention Name(s)
QAB149
Intervention Description
QAB149 and matching placebo will be supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
To mimic QAB149
Primary Outcome Measure Information:
Title
Number of Patients With Adverse Events, Serious Adverse Events, and Death
Description
The overall rate of adverse events reported from initiation through 30 days post last dose.
Time Frame
56 weeks
Secondary Outcome Measure Information:
Title
Time to Premature Discontinuation of Treatment
Description
methodTime 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 earl
Time Frame
56 weeks
Title
Change From Baseline in Pre-dose Trough 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. 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.
Time Frame
Day 29, 57,, 85, 141, 197, 253, 309 and 365
Title
Change From Baseline in 1 Hour Post-dose FEV1 Measurements
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. 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.
Time Frame
Day 1, 29, 57, 85, 141, 197, 253, 309, and 365
Title
Change From Baseline in FVC Measurement at All Post-baseline Time Points
Description
Pulmonary function assessments were performed using centralized spirometry according to international standards.
Time Frame
Day1, 29, 57, 85, 141, 197, 253, 309, and 365
Title
Percentage of Participants Experiencing Moderate or Severe COPD Exacerbation
Description
Percentage of participants experiencing moderate or severe Chronic Obstructive Pulmonary Disease (COPD)
Time Frame
52 weeks
Title
Change From Baseline in Mean Total Daily Symptom Scores
Description
The participant recorded symptom scores twice daily in the eDiary. The daily clinical symptoms included: cough, wheezing, shortness of breath, sputum volume, sputum color, and night time awakening. The range of scores for each assessment is 0 to 3 where 0 indications No symptom and 3 indicates a Severe symptom. The maximum daytime total score is 27 and the maximum nighttime total score is 27. The total daily symptom score is obtained by adding the scores for the morning and evening symptoms for each day. The maximum possible total daily score is 54. A negative change from baseline indicated improvement.
Time Frame
52 weeks
Title
Change From Baseline in the Daily Number of Puffs of Rescue Medication Over the 52 Week Period
Description
Participants completed an electronic diary (eDiary) twice daily at the same time in the morning and evening to record the number of puffs of rescue medication taken in the previous 12 hours.
Time Frame
52 weeks
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
Other protocol defined inclusion/exclusion criteria may apply
Facility Information:
Facility Name
Novartis Investigative Site
City
Vestavia
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Novartis Investigative Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Novartis Investigative Site
City
Lakewood
State/Province
California
ZIP/Postal Code
90712-151
Country
United States
Facility Name
Novartis Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Novartis Investigative Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Novartis Investigative Site
City
Stockton
State/Province
California
ZIP/Postal Code
95207
Country
United States
Facility Name
Novartis Investigative Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Novartis Investigative Site
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Novartis Investigative Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Novartis Investigative Site
City
Lombard
State/Province
Illinois
ZIP/Postal Code
60148
Country
United States
Facility Name
Novartis Investigative Site
City
O'Fallon
State/Province
Illinois
ZIP/Postal Code
62269
Country
United States
Facility Name
Novartis Investigative Site
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Novartis Investigative Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47712
Country
United States
Facility Name
Novartis Investigative Site
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
Novartis Investigative Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52240
Country
United States
Facility Name
Novartis Investigative Site
City
Waterloo
State/Province
Iowa
ZIP/Postal Code
50702
Country
United States
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Novartis Investigative Site
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
Novartis Investigative Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Novartis Investigative Site
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70458
Country
United States
Facility Name
Novartis Investigative Site
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Novartis Investigative Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Novartis Investigative Site
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48152
Country
United States
Facility Name
Novartis Investigative Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Novartis Investigative Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39209
Country
United States
Facility Name
Novartis Investigative Site
City
Picayune
State/Province
Mississippi
ZIP/Postal Code
39466
Country
United States
Facility Name
Novartis Investigative Site
City
St. Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
Novartis Investigative Site
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Novartis Investigative Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Novartis Investigative Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Novartis Investigative Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89014
Country
United States
Facility Name
Novartis Investigative Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Novartis Investigative Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Novartis Investigative Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Novartis Investigative Site
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
Facility Name
Novartis Investigative Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Novartis Investigative Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Novartis Investigative Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
Country
United States
Facility Name
Novartis Investigative Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504-8741
Country
United States
Facility Name
Novartis Investigative Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Novartis Investigative Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37912
Country
United States
Facility Name
Novartis Investigative Site
City
Corsicana
State/Province
Texas
ZIP/Postal Code
75110
Country
United States
Facility Name
Novartis Investigative Site
City
Ft. Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Novartis Investigative Site
City
Lufkin
State/Province
Texas
ZIP/Postal Code
75904
Country
United States
Facility Name
Novartis Investigative Site
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Facility Name
Novartis Investigative Site
City
Abingdon
State/Province
Virginia
ZIP/Postal Code
24210
Country
United States
Facility Name
Novartis Investigative Site
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
Facility Name
Novartis Investigative Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Novartis Investigative Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Novartis Investigative Site
City
HUS
ZIP/Postal Code
00029
Country
Finland
Facility Name
Novartis Investigative Site
City
Pori
ZIP/Postal Code
FIN-28500
Country
Finland
Facility Name
Novartis Investigative Site
City
Turku
ZIP/Postal Code
20521
Country
Finland
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1046
Country
Hungary
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Novartis Investigative Site
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Novartis Investigative Site
City
Mako
ZIP/Postal Code
6900
Country
Hungary
Facility Name
Novartis Investigative Site
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Novartis Investigative Site
City
Pecs
ZIP/Postal Code
7635
Country
Hungary
Facility Name
Novartis Investigative Site
City
Szazhalombatta
ZIP/Postal Code
2440
Country
Hungary
Facility Name
Novartis Investigative Site
City
Szolnok
ZIP/Postal Code
H-5000
Country
Hungary
Facility Name
Novartis Investigative Site
City
Torokbalint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Novartis Investigative Site
City
Barceloneta
ZIP/Postal Code
00617
Country
Puerto Rico
Facility Name
Novartis Investigative Site
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Novartis Investigative Site
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Novartis Investigative Site
City
Bucharest
State/Province
District 1
ZIP/Postal Code
10457
Country
Romania
Facility Name
Novartis Investigative Site
City
Bucharest
State/Province
District 1
ZIP/Postal Code
11475
Country
Romania
Facility Name
Novartis Investigative Site
City
Bucharest
State/Province
District 3
ZIP/Postal Code
030303
Country
Romania
Facility Name
Novartis Investigative Site
City
Bucharest
State/Province
District 3
ZIP/Postal Code
030317
Country
Romania
Facility Name
Novartis Investigative Site
City
Constanta
State/Province
Jud. Constanta
ZIP/Postal Code
900002
Country
Romania
Facility Name
Novartis Investigative Site
City
Iasi
State/Province
Jud. Iasi
ZIP/Postal Code
700115
Country
Romania
Facility Name
Novartis Investigative Site
City
Brasov
ZIP/Postal Code
500281
Country
Romania
Facility Name
Novartis Investigative Site
City
Bucharest
ZIP/Postal Code
060011
Country
Romania
Facility Name
Novartis Investigative Site
City
Bucuresti
ZIP/Postal Code
50554
Country
Romania
Facility Name
Novartis Investigative Site
City
Cluj-Napoca
ZIP/Postal Code
400371
Country
Romania
Facility Name
Novartis Investigative Site
City
Granada
State/Province
Andalucia
ZIP/Postal Code
18014
Country
Spain
Facility Name
Novartis Investigative Site
City
Málaga
State/Province
Andalucia
ZIP/Postal Code
29010
Country
Spain
Facility Name
Novartis Investigative Site
City
Badalona
State/Province
Cataluña
ZIP/Postal Code
08914
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Cataluña
Country
Spain
Facility Name
Novartis Investigative Site
City
Canet de Mar
State/Province
Cataluña
ZIP/Postal Code
08360
Country
Spain
Facility Name
Novartis Investigative Site
City
Centelles
State/Province
Cataluña
ZIP/Postal Code
08540
Country
Spain
Facility Name
Novartis Investigative Site
City
Tarragona
State/Province
Cataluña
ZIP/Postal Code
43350
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46015
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB149 in Patients With COPD Who Have Moderate to Severe Airflow Limitation
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