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The Effect of QVA149 on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD) (QUANTIFY)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
QVA149
Placebo to tiotropium
Placebo to formoterol
Tiotropium
Formoterol
Placebo to QVA149
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 QVA149, Health related quality of life, Formoterol, Tiotropium, COPD

Eligibility Criteria

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

Inclusion Criteria:

  • Male or female adults aged ≥ 40 yrs
  • Patients with moderate to severe chronic obstructive pulmonary disease (GOLD 2010 guidelines)
  • Smoking history of at least 10 pack years
  • Post-bronchodilator FEV1 < 80% and ≥30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%

Exclusion Criteria:

  • Pregnant women or nursing mothers or women of child-bearing potential not using adequate contraception
  • Patients with a history of long QT syndrome
  • Patients with Type I or uncontrolled Type II diabetes
  • Patients who have had a COPD exacerbation or respiratory tract infection within 6 weeks prior to screening
  • Patients with any history of asthma
  • Patients with pulmonary lobectomy, lung volume reduction surgery, or lung transplantation
  • Patients with concomitant pulmonary disease
  • Patients requiring long term oxygen therapy (>15 h a day)

Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

  • Novartis Investigative Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

QVA149 plus placebo to tiotropium and placebo to formoterol

Tiotropium plus Formoterol and placebo to QVA149

Arm Description

QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.

Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.

Outcomes

Primary Outcome Measures

St. George's Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Non-inferiority Analysis).
SGRQ is a health related quality of life questionnaire consisting of 40 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. For patients who completed the study but with missing SGRQ-C during treatment, the missing SGRQ-C were replaced by the last observation carried forward (LOCF). Symptom scores were expected to improve over treatment, therefore the replacement of missing values with earlier measurements did not result in overoptimistic imputation and this procedure could be regarded as conservative.

Secondary Outcome Measures

St. George's Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Superiority Analysis).
SGRQ is a health related quality of life questionnaire consisting of 40 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. For patients who completed the study but with missing SGRQ-C during treatment, the missing SGRQ-C were replaced by the last observation carried forward (LOCF). Symptom scores were expected to improve over treatment, therefore the replacement of missing values with earlier measurements did not result in overoptimistic imputation and this procedure could be regarded as conservative. Superiority of QVA 110/50 μg to tiotropium 18 μg q.d. plus formoterol 12 μg b.i.d. in terms of health related quality of life as assessed by St George's Respiratory Questionnaire (SGRQ-C) after 26 weeks of treatment
Transition Dyspnea Index (TDI) Focal Score After 26 Weeks of Treatment.
Baseline Dyspnea Index (BDI)/Transition Dyspnea Index (TDI) focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort and captures changes from baseline. BDI was measured at day 1 prior to the first dose with domain scores ranging from 0=very severe to 4=no impairment and a total score ranging from 0 to 12(best). TDI captures changes from baseline. Each domain is scored from -3=major deterioration to 3=major improvement to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score. missing values were replaced by the latest observed value (LOCF)
Percent of Participants With at Least One Exacerbation Requiring Systemic Corticosteroids and/or Antibiotics Over 26 Weeks
The percent of participants with at least one moderate exacerbation within the 26 weeks that required systemic corticosteroids and/or antibiotics during the treatment
Percent of Participants With at Least One Exacerbation Requiring Hospitalization
The percent of patients with at least one severe exacerbation within the 26 weeks that required hospitalization. COPD exacerbations were considered to be severe if hospitalization were required.
Time- Event Analysis, Number of Participants With at Least One COPD Exacerbation (Moderate or Severe) During the Treatment Period
The number of participants with at least one moderate or severe COPD exacerbation. COPD exacerbations are considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations are considered to be severe if hospitalizations were required.
Trough FEV1 at Baseline and Week 26
Trough FEV1 is the mean value of FEV1 (forced expiratory volume in one second) measured at 23:15h and 23:45h after the morning doses. The baseline value was measured at day 1 prior to the first dose.
FEV1 30 Min After the Morning Dose at Baseline and Week 26
FEV1 30min is the forced expiratory volume in one second measured 30 min after the morning dose.
Symptoms Score Reported by the Patients Using Part I "Symptoms" of SGRO-C
Part I of the SGRQ-C covers "symptoms" and is concerned with respiratory symptoms, their frequency and severity. Each questionnaire response has a unique empirically derived "weight". A score was calculated from these weights. The lowest possible value is zero and the highest 100. A higher value corresponds to greater impairment of health status.

Full Information

First Posted
April 6, 2012
Last Updated
May 19, 2014
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01574651
Brief Title
The Effect of QVA149 on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Acronym
QUANTIFY
Official Title
A 26-week Treatment, Multicenter, Randomized, Parallel Group, Blinded Study to Assess the Efficacy and Safety of QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease Using Tiotropium Plus Formoterol as Control
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will assess the efficacy and safety of QVA149 compared to tiotropium plus formoterol in patients with moderate to severe COPD.

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
QVA149, Health related quality of life, Formoterol, Tiotropium, COPD

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
QVA149 plus placebo to tiotropium and placebo to formoterol
Arm Type
Experimental
Arm Description
QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
Arm Title
Tiotropium plus Formoterol and placebo to QVA149
Arm Type
Active Comparator
Arm Description
Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
Intervention Type
Drug
Intervention Name(s)
QVA149
Intervention Description
QVA149 110/50µg, once daily (q.d.) is administered via a single-dose dry powder inhaler
Intervention Type
Drug
Intervention Name(s)
Placebo to tiotropium
Intervention Description
Placebo to tiotropium capsules daily (q.d.) for inhalation, delivered via proprietary inhaler (Handihaler®). Placebo tiotropium inhalation capsules were matched in size and color to tiotropium 18 μg q.d. inhalation capsules
Intervention Type
Drug
Intervention Name(s)
Placebo to formoterol
Intervention Description
Placebo to formoterol capsules twice daily (b.i.d) delivered via Aerolizer® device. Placebo formoterol inhalation capsules were equally matched in size, shape and color to formoterol 12 μg b.i.d. inhalation capsules.
Intervention Type
Drug
Intervention Name(s)
Tiotropium
Intervention Description
Tiotropium 18µg, once daily is administered via the manufacturer's proprietary inhalation device.
Intervention Type
Drug
Intervention Name(s)
Formoterol
Intervention Description
Formoterol 12µg, twice daily is administered via the manufacturer's proprietary inhalation device.
Intervention Type
Drug
Intervention Name(s)
Placebo to QVA149
Intervention Description
Placebo to QVA149 is administered via a single-dose dry powder inhaler. Placebo QVA149 inhalation capsules were equally matched in size, shape and color to QVA149 110/50 μg q.d. inhalation capsules
Primary Outcome Measure Information:
Title
St. George's Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Non-inferiority Analysis).
Description
SGRQ is a health related quality of life questionnaire consisting of 40 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. For patients who completed the study but with missing SGRQ-C during treatment, the missing SGRQ-C were replaced by the last observation carried forward (LOCF). Symptom scores were expected to improve over treatment, therefore the replacement of missing values with earlier measurements did not result in overoptimistic imputation and this procedure could be regarded as conservative.
Time Frame
Baseline, week 26
Secondary Outcome Measure Information:
Title
St. George's Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Superiority Analysis).
Description
SGRQ is a health related quality of life questionnaire consisting of 40 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. For patients who completed the study but with missing SGRQ-C during treatment, the missing SGRQ-C were replaced by the last observation carried forward (LOCF). Symptom scores were expected to improve over treatment, therefore the replacement of missing values with earlier measurements did not result in overoptimistic imputation and this procedure could be regarded as conservative. Superiority of QVA 110/50 μg to tiotropium 18 μg q.d. plus formoterol 12 μg b.i.d. in terms of health related quality of life as assessed by St George's Respiratory Questionnaire (SGRQ-C) after 26 weeks of treatment
Time Frame
Baseline, week 26
Title
Transition Dyspnea Index (TDI) Focal Score After 26 Weeks of Treatment.
Description
Baseline Dyspnea Index (BDI)/Transition Dyspnea Index (TDI) focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort and captures changes from baseline. BDI was measured at day 1 prior to the first dose with domain scores ranging from 0=very severe to 4=no impairment and a total score ranging from 0 to 12(best). TDI captures changes from baseline. Each domain is scored from -3=major deterioration to 3=major improvement to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score. missing values were replaced by the latest observed value (LOCF)
Time Frame
Week 26
Title
Percent of Participants With at Least One Exacerbation Requiring Systemic Corticosteroids and/or Antibiotics Over 26 Weeks
Description
The percent of participants with at least one moderate exacerbation within the 26 weeks that required systemic corticosteroids and/or antibiotics during the treatment
Time Frame
Week 26
Title
Percent of Participants With at Least One Exacerbation Requiring Hospitalization
Description
The percent of patients with at least one severe exacerbation within the 26 weeks that required hospitalization. COPD exacerbations were considered to be severe if hospitalization were required.
Time Frame
Week 26
Title
Time- Event Analysis, Number of Participants With at Least One COPD Exacerbation (Moderate or Severe) During the Treatment Period
Description
The number of participants with at least one moderate or severe COPD exacerbation. COPD exacerbations are considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations are considered to be severe if hospitalizations were required.
Time Frame
Week 26
Title
Trough FEV1 at Baseline and Week 26
Description
Trough FEV1 is the mean value of FEV1 (forced expiratory volume in one second) measured at 23:15h and 23:45h after the morning doses. The baseline value was measured at day 1 prior to the first dose.
Time Frame
Baseline, Week 26
Title
FEV1 30 Min After the Morning Dose at Baseline and Week 26
Description
FEV1 30min is the forced expiratory volume in one second measured 30 min after the morning dose.
Time Frame
Baseline, Week 26
Title
Symptoms Score Reported by the Patients Using Part I "Symptoms" of SGRO-C
Description
Part I of the SGRQ-C covers "symptoms" and is concerned with respiratory symptoms, their frequency and severity. Each questionnaire response has a unique empirically derived "weight". A score was calculated from these weights. The lowest possible value is zero and the highest 100. A higher value corresponds to greater impairment of health status.
Time Frame
Baseline, Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female adults aged ≥ 40 yrs Patients with moderate to severe chronic obstructive pulmonary disease (GOLD 2010 guidelines) Smoking history of at least 10 pack years Post-bronchodilator FEV1 < 80% and ≥30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70% Exclusion Criteria: Pregnant women or nursing mothers or women of child-bearing potential not using adequate contraception Patients with a history of long QT syndrome Patients with Type I or uncontrolled Type II diabetes Patients who have had a COPD exacerbation or respiratory tract infection within 6 weeks prior to screening Patients with any history of asthma Patients with pulmonary lobectomy, lung volume reduction surgery, or lung transplantation Patients with concomitant pulmonary disease Patients requiring long term oxygen therapy (>15 h a day) Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Koblenz
State/Province
NRW
ZIP/Postal Code
56068
Country
Germany
Facility Name
Novartis Investigative Site
City
Cottbus
State/Province
Sachsen
ZIP/Postal Code
03050
Country
Germany
Facility Name
Novartis Investigative Site
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Novartis Investigative Site
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Facility Name
Novartis Investigative Site
City
Bad Neustadt
ZIP/Postal Code
97616
Country
Germany
Facility Name
Novartis Investigative Site
City
Bad Woerishofen
ZIP/Postal Code
86825
Country
Germany
Facility Name
Novartis Investigative Site
City
Bamberg
ZIP/Postal Code
96049
Country
Germany
Facility Name
Novartis Investigative Site
City
Bensheim
ZIP/Postal Code
64625
Country
Germany
Facility Name
Novartis Investigative Site
City
Bergisch Gladbach
ZIP/Postal Code
51429
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10115
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10367
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10717
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10789
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10969
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12043
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12099
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Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12165
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12203
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Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12687
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Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13057
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Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13086
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13156
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Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13465
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Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13507
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
14050
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Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
14059
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Germany
Facility Name
Novartis Investigative Site
City
Bielefeld
ZIP/Postal Code
33617
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Germany
Facility Name
Novartis Investigative Site
City
Bochum
ZIP/Postal Code
44787
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Germany
Facility Name
Novartis Investigative Site
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Bonn
ZIP/Postal Code
53119
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Germany
Facility Name
Novartis Investigative Site
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Bonn
ZIP/Postal Code
53123
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Germany
Facility Name
Novartis Investigative Site
City
Borna
ZIP/Postal Code
04552
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Germany
Facility Name
Novartis Investigative Site
City
Chemnitz
ZIP/Postal Code
09130
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Germany
Facility Name
Novartis Investigative Site
City
Delitzsch
ZIP/Postal Code
04509
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Germany
Facility Name
Novartis Investigative Site
City
Donaustauf
ZIP/Postal Code
93093
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Germany
Facility Name
Novartis Investigative Site
City
Dortmund
ZIP/Postal Code
44135
Country
Germany
Facility Name
Novartis Investigative Site
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Dresden
ZIP/Postal Code
01069
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Germany
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Novartis Investigative Site
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Dueren
ZIP/Postal Code
52349
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Germany
Facility Name
Novartis Investigative Site
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Duisburg
ZIP/Postal Code
47057
Country
Germany
Facility Name
Novartis Investigative Site
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Düsseldorf
ZIP/Postal Code
40489
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Germany
Facility Name
Novartis Investigative Site
City
Eggenfelden
ZIP/Postal Code
84307
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Germany
Facility Name
Novartis Investigative Site
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Eisenach
ZIP/Postal Code
99817
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Germany
Facility Name
Novartis Investigative Site
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Erlangen
ZIP/Postal Code
91052
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Germany
Facility Name
Novartis Investigative Site
City
Eschwege
ZIP/Postal Code
37269
Country
Germany
Facility Name
Novartis Investigative Site
City
Essen
ZIP/Postal Code
45138
Country
Germany
Facility Name
Novartis Investigative Site
City
Essen
ZIP/Postal Code
45276
Country
Germany
Facility Name
Novartis Investigative Site
City
Euskirchen
ZIP/Postal Code
53879
Country
Germany
Facility Name
Novartis Investigative Site
City
Forchheim
ZIP/Postal Code
91301
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Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60389
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Novartis Investigative Site
City
Fulda
ZIP/Postal Code
36039
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Germany
Facility Name
Novartis Investigative Site
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Gauting
ZIP/Postal Code
82131
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Germany
Facility Name
Novartis Investigative Site
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Geesthacht
ZIP/Postal Code
22502
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Germany
Facility Name
Novartis Investigative Site
City
Gelnhausen
ZIP/Postal Code
63571
Country
Germany
Facility Name
Novartis Investigative Site
City
Gelsenkirchen
ZIP/Postal Code
45879
Country
Germany
Facility Name
Novartis Investigative Site
City
Grosshansdorf
ZIP/Postal Code
22947
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Germany
Facility Name
Novartis Investigative Site
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Gummersbach
ZIP/Postal Code
51643
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Germany
Facility Name
Novartis Investigative Site
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Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Novartis Investigative Site
City
Güstrow
ZIP/Postal Code
18273
Country
Germany
Facility Name
Novartis Investigative Site
City
Hagen
ZIP/Postal Code
59065
Country
Germany
Facility Name
Novartis Investigative Site
City
Halberstadt
ZIP/Postal Code
38820
Country
Germany
Facility Name
Novartis Investigative Site
City
Halle
ZIP/Postal Code
06108
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
20357
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
22299
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
22527
Country
Germany
Facility Name
Novartis Investigative Site
City
Hannover Münden
ZIP/Postal Code
34346
Country
Germany
Facility Name
Novartis Investigative Site
City
Hannover
ZIP/Postal Code
30163
Country
Germany
Facility Name
Novartis Investigative Site
City
Hannover
ZIP/Postal Code
30317
Country
Germany
Facility Name
Novartis Investigative Site
City
Hannover
ZIP/Postal Code
30419
Country
Germany
Facility Name
Novartis Investigative Site
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Novartis Investigative Site
City
Heidelberg
ZIP/Postal Code
69117
Country
Germany
Facility Name
Novartis Investigative Site
City
Hettstedt
ZIP/Postal Code
06333
Country
Germany
Facility Name
Novartis Investigative Site
City
Hildesheim
ZIP/Postal Code
31134
Country
Germany
Facility Name
Novartis Investigative Site
City
Höchstadt
ZIP/Postal Code
91315
Country
Germany
Facility Name
Novartis Investigative Site
City
Kamenz
ZIP/Postal Code
01917
Country
Germany
Facility Name
Novartis Investigative Site
City
Kamen
ZIP/Postal Code
59174
Country
Germany
Facility Name
Novartis Investigative Site
City
Kassel
ZIP/Postal Code
34121
Country
Germany
Facility Name
Novartis Investigative Site
City
Koeln
ZIP/Postal Code
51069
Country
Germany
Facility Name
Novartis Investigative Site
City
Krefeld
ZIP/Postal Code
47798
Country
Germany
Facility Name
Novartis Investigative Site
City
Köln
ZIP/Postal Code
51605
Country
Germany
Facility Name
Novartis Investigative Site
City
Landsberg
ZIP/Postal Code
86899
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04207
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04275
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04357
Country
Germany
Facility Name
Novartis Investigative Site
City
Luedenscheid
ZIP/Postal Code
58507
Country
Germany
Facility Name
Novartis Investigative Site
City
Lübeck
ZIP/Postal Code
23558
Country
Germany
Facility Name
Novartis Investigative Site
City
Mainz
ZIP/Postal Code
55116
Country
Germany
Facility Name
Novartis Investigative Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Novartis Investigative Site
City
Mannheim
ZIP/Postal Code
68165
Country
Germany
Facility Name
Novartis Investigative Site
City
Marburg
ZIP/Postal Code
35037
Country
Germany
Facility Name
Novartis Investigative Site
City
Menden
ZIP/Postal Code
58706
Country
Germany
Facility Name
Novartis Investigative Site
City
Minden
ZIP/Postal Code
32423
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenchen
ZIP/Postal Code
80539
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenchen
ZIP/Postal Code
81677
Country
Germany
Facility Name
Novartis Investigative Site
City
München
ZIP/Postal Code
80335
Country
Germany
Facility Name
Novartis Investigative Site
City
Münster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Novartis Investigative Site
City
Münster
ZIP/Postal Code
48147
Country
Germany
Facility Name
Novartis Investigative Site
City
Neu Isenburg
ZIP/Postal Code
63263
Country
Germany
Facility Name
Novartis Investigative Site
City
Neu-Ulm
ZIP/Postal Code
89231
Country
Germany
Facility Name
Novartis Investigative Site
City
Neumünster
ZIP/Postal Code
24534
Country
Germany
Facility Name
Novartis Investigative Site
City
Neunkirchen
ZIP/Postal Code
66539
Country
Germany
Facility Name
Novartis Investigative Site
City
Neuruppin
ZIP/Postal Code
16816
Country
Germany
Facility Name
Novartis Investigative Site
City
Neuss
ZIP/Postal Code
41462
Country
Germany
Facility Name
Novartis Investigative Site
City
Oranienburg
ZIP/Postal Code
16515
Country
Germany
Facility Name
Novartis Investigative Site
City
Oschatz
ZIP/Postal Code
04758
Country
Germany
Facility Name
Novartis Investigative Site
City
Oschersleben
ZIP/Postal Code
39387
Country
Germany
Facility Name
Novartis Investigative Site
City
Osnabrück
ZIP/Postal Code
49074
Country
Germany
Facility Name
Novartis Investigative Site
City
Peine
ZIP/Postal Code
31224
Country
Germany
Facility Name
Novartis Investigative Site
City
Potsdam
ZIP/Postal Code
14467
Country
Germany
Facility Name
Novartis Investigative Site
City
Potsdam
ZIP/Postal Code
14469
Country
Germany
Facility Name
Novartis Investigative Site
City
Potsdam
ZIP/Postal Code
14478
Country
Germany
Facility Name
Novartis Investigative Site
City
Prien a. Chiemsee
ZIP/Postal Code
83209
Country
Germany
Facility Name
Novartis Investigative Site
City
Radebeul
ZIP/Postal Code
01445
Country
Germany
Facility Name
Novartis Investigative Site
City
Rathenow
ZIP/Postal Code
14712
Country
Germany
Facility Name
Novartis Investigative Site
City
Ratingen
ZIP/Postal Code
40878
Country
Germany
Facility Name
Novartis Investigative Site
City
Reinfeld
ZIP/Postal Code
23858
Country
Germany
Facility Name
Novartis Investigative Site
City
Rheine
ZIP/Postal Code
48431
Country
Germany
Facility Name
Novartis Investigative Site
City
Roth
ZIP/Postal Code
91154
Country
Germany
Facility Name
Novartis Investigative Site
City
Rüdersdorf
ZIP/Postal Code
15562
Country
Germany
Facility Name
Novartis Investigative Site
City
Rüsselsheim
ZIP/Postal Code
65428
Country
Germany
Facility Name
Novartis Investigative Site
City
Saarbruecken
ZIP/Postal Code
66111
Country
Germany
Facility Name
Novartis Investigative Site
City
Saarlouis
ZIP/Postal Code
66740
Country
Germany
Facility Name
Novartis Investigative Site
City
Schleswig
ZIP/Postal Code
24837
Country
Germany
Facility Name
Novartis Investigative Site
City
Schwabach
ZIP/Postal Code
91126
Country
Germany
Facility Name
Novartis Investigative Site
City
Siegen
ZIP/Postal Code
57072
Country
Germany
Facility Name
Novartis Investigative Site
City
Singen
ZIP/Postal Code
76224
Country
Germany
Facility Name
Novartis Investigative Site
City
Solingen
ZIP/Postal Code
42651
Country
Germany
Facility Name
Novartis Investigative Site
City
Solingen
ZIP/Postal Code
42665
Country
Germany
Facility Name
Novartis Investigative Site
City
Sonneberg
ZIP/Postal Code
96515
Country
Germany
Facility Name
Novartis Investigative Site
City
Stade
ZIP/Postal Code
21680
Country
Germany
Facility Name
Novartis Investigative Site
City
Teterow
ZIP/Postal Code
17166
Country
Germany
Facility Name
Novartis Investigative Site
City
Teuchern
ZIP/Postal Code
06682
Country
Germany
Facility Name
Novartis Investigative Site
City
Ulm
ZIP/Postal Code
89073
Country
Germany
Facility Name
Novartis Investigative Site
City
Vöhringen
ZIP/Postal Code
89269
Country
Germany
Facility Name
Novartis Investigative Site
City
Wedel
ZIP/Postal Code
22880
Country
Germany
Facility Name
Novartis Investigative Site
City
Weyhe
ZIP/Postal Code
28844
Country
Germany
Facility Name
Novartis Investigative Site
City
Wiesloch
ZIP/Postal Code
69168
Country
Germany
Facility Name
Novartis Investigative Site
City
Wissen
ZIP/Postal Code
57537
Country
Germany
Facility Name
Novartis Investigative Site
City
Witten
ZIP/Postal Code
58452
Country
Germany
Facility Name
Novartis Investigative Site
City
Wuppertal
ZIP/Postal Code
42117
Country
Germany
Facility Name
Novartis Investigative Site
City
Zerbst
ZIP/Postal Code
39261
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

The Effect of QVA149 on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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