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A Study of the Efficacy and Safety of NVA237 in Patients With Moderate to Severe COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

NVA237

Placebo

Salbutamol

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Anticholinergic, Antimuscarinic, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease, Chronic Obstructive Pulmonary Disease, COPD, LAMA, Lung Disease, Lung Diseases, Obstructive, Lung Function, Muscarinic receptor antagonist, Pulmonary Disease, Chronic Obstructive, Respiratory Tract Diseases

Eligibility Criteria

41 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written informed consent must be obtained before any assessment is performed
Male and female adults aged ≥40 years
Patients with stable COPD according to the current GOLD strategy (GOLD 2014)
Current or ex-smokers who have a smoking history of at least 10 pack years- an ex-smoker may be defined as a subject who has not smoked for ≥ 6 months at screening
mMRC grade of at least 2 at Visit 101
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 at Visit 101.

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 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
Patients with Type I or uncontrolled Type II diabetes; Patients with a history of long QT syndrome or whose QTc measured at run-in (Fridericia method) is prolonged (>450 ms for males and >460 for females) and confirmed by a central assessor
Patients requiring long term oxygen therapy prescribed for >12 h per day; Patients with any history of asthma.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

NVA237 Twice daily

NVA237 Once daily

Arm Description

Patients randomized to this arm received an NVA237 22 μg capsule in the morning and evening for 26 weeks. All participants received salbutamol as rescue medicine.

Patients randomized to this arm received an NVA237 44 μg capsule in the morning and a placebo capsule in the evening for 26 weeks. All participants received salbutamol as rescue medicine.

Outcomes

Primary Outcome Measures

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12

Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 defined as the mean of two measurements at 23 hours 15 minutes and 23 hour 45 minutes post dosing. Baseline FEV1 was defined as the average of the -45 minutes and -15 minutes FEV1 values taken on Day 1. An analysis-of-covariance (ANCOVA) for repeated measurements, also known as mixed model for repeated measures (MMRM), was performed for the change from baseline of trough FEV1 at Week 12. The model included treatment, COPD severity, baseline smoking status, baseline ICS use, region, and visit (Day 1, and Weeks 12 and 26) as factors and baseline FEV1 as a covariate.

Secondary Outcome Measures

Change From Baseline in Area Under The Curve (AUC) for Forced Expiratory Volume in One Second (FEV1) for Different Time Spans Post Dosing at Week 12

The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) is assessed for different time spans (0-12h, 0-24h, 12-24h) within the overall serial measurement post dosing at week 12 of treatment. Baseline FEV1 was defined as the average of the -45 minutes and -15 minutes FEV1 values taken on Day 1.

Change From Baseline in Area Under The Curve (AUC 0-12 Hour) for Forced Expiratory Volume in One Second (FEV1) Post Dosing at Day 1

The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) is assessed for 0-12 hour, post dosing at Day 1 of treatment. Baseline FEV1 was defined as the average of the -45 minutes and -15 minutes FEV1 values taken on Day 1.

Change From Baseline in Area Under The Curve (AUC) for Forced Expiratory Volume in One Second (FEV1) for Different Time Spans Post Dosing at Week 26

The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) is assessed for different time spans (0-12h, 0-24h, 12-24h) within the overall serial measurement post dosing at week 26 of treatment. Baseline FEV1 was defined as the average of the -45 minutes and -15 minutes FEV1 values taken on Day 1.

Change From Baseline in Total St. George's Respiratory Questionnaire (SGRQ) Score at Week 12 and Week 26

The health status, as reported by the patients, is assessed using the St. George's Respiratory Questionnaire (SGRQ). The SGRQ contains 50 items divided into 2 parts covering 3 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 caused 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 was calculated for each of these three subscales and the total score was calculated. In each case, the lowest possible value was 0 and the highest 100. Higher values corresponded to greater impairment of health status.

Percentage of Patients With a Clinically Significant Improvement in St George Respiratory Questionnaire at Week 12 and Week 26

The health status, as reported by the patients, is assessed using the St. George's Respiratory Questionnaire (SGRQ). The SGRQ contains 50 items divided into 2 parts covering 3 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 caused 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 was calculated for each of these three subscales and the total score was calculated. In each case, the lowest possible value was 0 and the highest 100. A clinically significant improvement is defined as ≥ 4 unit improvement from baseline score (a decrease of ≥ 4).

Change From Baseline in Transitional Dyspnea Index (TDI) Focal Score at Week 12 and Week 26

Breathlessness at Week 12 and Week 26 is measured using the Transition Dyspnea Index (TDI). On day 1, breathlessness is assessed by the Baseline Dyspnea Index (BDI). 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.

Percentage of Patients With a Clinically Important Improvement on Transitional Dyspnea Index (TDI) Focal Score at Week 12 and Week 26

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1 and Week 26

Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 defined as the mean of two measurements at 23 hours 15 minutes and 23 hour 45 minutes post dosing. Baseline FEV1 was defined as the average of the -45 minutes and -15 minutes FEV1 values taken on Day 1. An analysis-of-covariance (ANCOVA) for repeated measurements, also known as mixed model for repeated measures (MMRM), was performed for the change from baseline of trough FEV1. The model included treatment, COPD severity, baseline smoking status, baseline ICS use, region, and visit (Day 1, and Weeks 12 and 26) as factors and baseline FEV1 as a covariate.

Change From Baseline in Forced Vital Capacity (FVC) at Individual Timepoints at Week 26

Mixed model for repeated measures was used to analyze change from baseline in FVC. Baseline FVC is defined as the average of the -45 min and -15 min FVC values taken on Day 1 prior to first dose.

Change From Baseline in Inspiratory Capacity (IC) at Individual Timepoints at Week 26

Mixed model for repeated measures was used to analyze change from baseline in IC.

Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Individual Timepoints at Week 26

Mixed model for repeated measures was used to analyze change from baseline in FEV1. Baseline FEV1 is defined as the average of the -45 min and -15 min FEV1 values taken on Day 1 prior to first dose.

Change From Baseline in the Percentage of Days With no Rescue Medication Use Over the 26 Weeks

Patients report the number of puffs of rescue medication (salbutamol / albuterol) using an electronic diary. change from baseline in percentage of days without rescue medication usage over 26 weeks was analyzed.

Change From Baseline in Mean Daily COPD Symptom Score at Week 26

Patients reported symptoms by using an electronic diary. The mean daily total symptom score, the mean morning symptom score and the mean evening symptom score were calculated for each patient over 26 weeks. Each symptom measured in a numeric rating scale of 0-10; 0 indicates no symptom and 10 indicates severe symptom. 0 is no waking due to symptoms, 1 woke up once, 2 woke up more than once due to symptoms ; 10 was the worst score.The daily score for an individual symptom score was the worst of the morning and evening scores on a particular day. If either the morning or evening score was missing for a symptom then the non-missing value was taken as the worst. A negative change indicates improvement. Only the scores for the 6 COPD symptoms (respiratory symptoms, cough, wheeze, production of sputum, sputum color, and breathlessness) were used to derive the total symptom score

Number of Patients With Adverse Events, Serious Adverse Events and Death

This endpoint reports patients affected by any adverse events (AE), serious adverse events (SAE) and death. Only treatment emergent AE, SAE, deaths are reported for this endpoint.

Full Information

NCT ID

NCT02371629

First Posted

February 19, 2015

Last Updated

June 21, 2019

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02371629

Brief Title

A Study of the Efficacy and Safety of NVA237 in Patients With Moderate to Severe COPD

Official Title

A Randomized, Double-blind, Parallel Group, 26-week Study Evaluating the Efficacy, Safety and Tolerability of NVA237 Given Once or Twice Daily, in Patients With Moderate and Severe Chronic Obstructive Pulmonary Disease

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

June 24, 2015 (Actual)

Primary Completion Date

November 16, 2016 (Actual)

Study Completion Date

November 16, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study is a post-authorization commitment to the European Medicines Agency (EMA). The study serves to determine whether the treatment of patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is efficient and safe. The efficacy and safety of the drug was tested for twice daily dosing against once daily dosing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

Anticholinergic, Antimuscarinic, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease, Chronic Obstructive Pulmonary Disease, COPD, LAMA, Lung Disease, Lung Diseases, Obstructive, Lung Function, Muscarinic receptor antagonist, Pulmonary Disease, Chronic Obstructive, Respiratory Tract Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

776 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NVA237 Twice daily

Arm Type

Experimental

Arm Description

Patients randomized to this arm received an NVA237 22 μg capsule in the morning and evening for 26 weeks. All participants received salbutamol as rescue medicine.

Arm Title

NVA237 Once daily

Arm Type

Experimental

Arm Description

Patients randomized to this arm received an NVA237 44 μg capsule in the morning and a placebo capsule in the evening for 26 weeks. All participants received salbutamol as rescue medicine.

Intervention Type

Drug

Intervention Name(s)

NVA237

Other Intervention Name(s)

glycopyrronioum bromide

Intervention Description

NVA237 capsules for inhalation, delivered via a Single Dose Dry Powder Inhaler (SDDPI) called Concept1

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo to NVA237

Intervention Type

Drug

Intervention Name(s)

Salbutamol

Intervention Description

All patients received salbutamol (100 μg) as only rescue medication

Primary Outcome Measure Information:

Title

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12

Description

Time Frame

Baseline, Week 12

Secondary Outcome Measure Information:

Title

Change From Baseline in Area Under The Curve (AUC) for Forced Expiratory Volume in One Second (FEV1) for Different Time Spans Post Dosing at Week 12

Description

Time Frame

Baseline, 0-12 hour, 0-24 hour , 12-24 hour post dose at Week 12

Title

Change From Baseline in Area Under The Curve (AUC 0-12 Hour) for Forced Expiratory Volume in One Second (FEV1) Post Dosing at Day 1

Description

Time Frame

Baseline, 0-12 hour post dose at Day 1

Title

Change From Baseline in Area Under The Curve (AUC) for Forced Expiratory Volume in One Second (FEV1) for Different Time Spans Post Dosing at Week 26

Description

The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) is assessed for different time spans (0-12h, 0-24h, 12-24h) within the overall serial measurement post dosing at week 26 of treatment. Baseline FEV1 was defined as the average of the -45 minutes and -15 minutes FEV1 values taken on Day 1.

Time Frame

Baseline, 0-12 hour, 0-24 hour , 12-24 hour post dose at Week 26

Title

Change From Baseline in Total St. George's Respiratory Questionnaire (SGRQ) Score at Week 12 and Week 26

Description

Time Frame

Baseline, 12 Weeks, 26 Weeks

Title

Percentage of Patients With a Clinically Significant Improvement in St George Respiratory Questionnaire at Week 12 and Week 26

Description

The health status, as reported by the patients, is assessed using the St. George's Respiratory Questionnaire (SGRQ). The SGRQ contains 50 items divided into 2 parts covering 3 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 caused 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 was calculated for each of these three subscales and the total score was calculated. In each case, the lowest possible value was 0 and the highest 100. A clinically significant improvement is defined as ≥ 4 unit improvement from baseline score (a decrease of ≥ 4).

Time Frame

Baseline, 12 Weeks, 26 Weeks

Title

Change From Baseline in Transitional Dyspnea Index (TDI) Focal Score at Week 12 and Week 26

Description

Time Frame

Baseline, 12 Weeks, 26 Weeks

Title

Percentage of Patients With a Clinically Important Improvement on Transitional Dyspnea Index (TDI) Focal Score at Week 12 and Week 26

Description

Time Frame

Baseline, 12 Weeks, 26 Weeks

Title

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1 and Week 26

Description

Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 defined as the mean of two measurements at 23 hours 15 minutes and 23 hour 45 minutes post dosing. Baseline FEV1 was defined as the average of the -45 minutes and -15 minutes FEV1 values taken on Day 1. An analysis-of-covariance (ANCOVA) for repeated measurements, also known as mixed model for repeated measures (MMRM), was performed for the change from baseline of trough FEV1. The model included treatment, COPD severity, baseline smoking status, baseline ICS use, region, and visit (Day 1, and Weeks 12 and 26) as factors and baseline FEV1 as a covariate.

Time Frame

Baseline, Day 1, Week 26

Title

Change From Baseline in Forced Vital Capacity (FVC) at Individual Timepoints at Week 26

Description

Mixed model for repeated measures was used to analyze change from baseline in FVC. Baseline FVC is defined as the average of the -45 min and -15 min FVC values taken on Day 1 prior to first dose.

Time Frame

Baseline, Week 26 (Day 183-184)

Title

Change From Baseline in Inspiratory Capacity (IC) at Individual Timepoints at Week 26

Description

Mixed model for repeated measures was used to analyze change from baseline in IC.

Time Frame

Baseline, Week 26 (Day 183-184)

Title

Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Individual Timepoints at Week 26

Description

Mixed model for repeated measures was used to analyze change from baseline in FEV1. Baseline FEV1 is defined as the average of the -45 min and -15 min FEV1 values taken on Day 1 prior to first dose.

Time Frame

Baseline, Week 26 (Day 183-184)

Title

Change From Baseline in the Percentage of Days With no Rescue Medication Use Over the 26 Weeks

Description

Time Frame

Baseline, 26 Weeks

Title

Change From Baseline in Mean Daily COPD Symptom Score at Week 26

Description

Time Frame

Baseline, 26 Weeks

Title

Number of Patients With Adverse Events, Serious Adverse Events and Death

Description

This endpoint reports patients affected by any adverse events (AE), serious adverse events (SAE) and death. Only treatment emergent AE, SAE, deaths are reported for this endpoint.

Time Frame

26 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

41 Years

Maximum Age & Unit of Time

84 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent must be obtained before any assessment is performed Male and female adults aged ≥40 years Patients with stable COPD according to the current GOLD strategy (GOLD 2014) Current or ex-smokers who have a smoking history of at least 10 pack years- an ex-smoker may be defined as a subject who has not smoked for ≥ 6 months at screening mMRC grade of at least 2 at Visit 101 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 at Visit 101. 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 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 Patients with Type I or uncontrolled Type II diabetes; Patients with a history of long QT syndrome or whose QTc measured at run-in (Fridericia method) is prolonged (>450 ms for males and >460 for females) and confirmed by a central assessor Patients requiring long term oxygen therapy prescribed for >12 h per day; Patients with any history of asthma.

Facility Information:

Facility Name

Novartis Investigative Site

City

Genk

State/Province

Limburg

ZIP/Postal Code

3600

Country

Belgium

Facility Name

Novartis Investigative Site

City

Jambes

State/Province

Namur

ZIP/Postal Code

5100

Country

Belgium

Facility Name

Novartis Investigative Site

City

Sevlievo

State/Province

Gabrovo

ZIP/Postal Code

5400

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

State/Province

Sofia-Grad

ZIP/Postal Code

1336

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Gabrovo

ZIP/Postal Code

5300

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Kozloduj

ZIP/Postal Code

3320

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Lom

ZIP/Postal Code

3600

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Lovech

ZIP/Postal Code

5500

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Montana

ZIP/Postal Code

3400

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Razgrad

ZIP/Postal Code

7200

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Roman

ZIP/Postal Code

3130

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Ruse

ZIP/Postal Code

7000

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Silistra

ZIP/Postal Code

7500

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sliven

ZIP/Postal Code

8800

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Smolyan

ZIP/Postal Code

4700

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1202

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1233

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Troyan

ZIP/Postal Code

5600

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Veliko Tarnovo

ZIP/Postal Code

5000

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Vidin

ZIP/Postal Code

3700

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Turku

ZIP/Postal Code

FIN-20100

Country

Finland

Facility Name

Novartis Investigative Site

City

Heidelberg

State/Province

Baden-Württemberg

ZIP/Postal Code

69126

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30159

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30167

Country

Germany

Facility Name

Novartis Investigative Site

City

Koblenz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

56068

Country

Germany

Facility Name

Novartis Investigative Site

City

Großhansdorf

State/Province

Schleswig-Holstein

ZIP/Postal Code

22927

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01069

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60596

Country

Germany

Facility Name

Novartis Investigative Site

City

Greifswald

ZIP/Postal Code

17475

Country

Germany

Facility Name

Novartis Investigative Site

City

Lubeck

ZIP/Postal Code

23552

Country

Germany

Facility Name

Novartis Investigative Site

City

Schwerin

ZIP/Postal Code

19055

Country

Germany

Facility Name

Novartis Investigative Site

City

Wiesbaden

ZIP/Postal Code

65187

Country

Germany

Facility Name

Novartis Investigative Site

City

Balassagyarmat

ZIP/Postal Code

2660

Country

Hungary

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Novartis Investigative Site

City

Farkasgyepu

ZIP/Postal Code

8582

Country

Hungary

Facility Name

Novartis Investigative Site

City

Pecs

ZIP/Postal Code

7635

Country

Hungary

Facility Name

Novartis Investigative Site

City

Sopron

ZIP/Postal Code

H-9400

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szarvas

ZIP/Postal Code

5540

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szeged

ZIP/Postal Code

6722

Country

Hungary

Facility Name

Novartis Investigative Site

City

Rehovot

ZIP/Postal Code

7610001

Country

Israel

Facility Name

Novartis Investigative Site

City

Wroclaw

State/Province

Dolnoslaskie

ZIP/Postal Code

53-301

Country

Poland

Facility Name

Novartis Investigative Site

City

Lodz

State/Province

Lódzkie

ZIP/Postal Code

90-153

Country

Poland

Facility Name

Novartis Investigative Site

City

Tarnow

State/Province

Malopolskie

ZIP/Postal Code

33-100

Country

Poland

Facility Name

Novartis Investigative Site

City

Chorzow

State/Province

Slaskie

ZIP/Postal Code

41-500

Country

Poland

Facility Name

Novartis Investigative Site

City

Bialystok

ZIP/Postal Code

15-044

Country

Poland

Facility Name

Novartis Investigative Site

City

Gdansk

ZIP/Postal Code

80 952

Country

Poland

Facility Name

Novartis Investigative Site

City

Kielce

ZIP/Postal Code

25-751

Country

Poland

Facility Name

Novartis Investigative Site

City

Lodz

ZIP/Postal Code

90-141

Country

Poland

Facility Name

Novartis Investigative Site

City

Sopot

ZIP/Postal Code

81-741

Country

Poland

Facility Name

Novartis Investigative Site

City

Wilkowice

ZIP/Postal Code

43-365

Country

Poland

Facility Name

Novartis Investigative Site

City

Craiova

State/Province

Dolj

ZIP/Postal Code

200515

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

Tg Mures

State/Province

Mures

ZIP/Postal Code

540136

Country

Romania

Facility Name

Novartis Investigative Site

City

Timisoara

State/Province

Timis

ZIP/Postal Code

300310

Country

Romania

Facility Name

Novartis Investigative Site

City

Baia Mare

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

ZIP/Postal Code

030317

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucuresti

ZIP/Postal Code

050159

Country

Romania

Facility Name

Novartis Investigative Site

City

Cluj Napoca

ZIP/Postal Code

400162

Country

Romania

Facility Name

Novartis Investigative Site

City

Cluj-Napoca

ZIP/Postal Code

400371

Country

Romania

Facility Name

Novartis Investigative Site

City

Kazan

State/Province

Tatarstan Republic

ZIP/Postal Code

420015

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Chelyabinsk

ZIP/Postal Code

454021

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Izhevsk

ZIP/Postal Code

426061

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kemerovo

ZIP/Postal Code

650002

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kemerovo

ZIP/Postal Code

650099

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

603011

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Ryazan

ZIP/Postal Code

390039

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Sestroretsk

ZIP/Postal Code

197706

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Smolensk

ZIP/Postal Code

214019

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St Petersburg

ZIP/Postal Code

194325

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St. Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Yaroslavl

ZIP/Postal Code

150000

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Yaroslavl

ZIP/Postal Code

150062

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Linkoping

State/Province

Ostergotlands Lan

ZIP/Postal Code

587 58

Country

Sweden

Facility Name

Novartis Investigative Site

City

Malmo

State/Province

Skane Lan

ZIP/Postal Code

21152

Country

Sweden

Facility Name

Novartis Investigative Site

City

Lidingo

State/Province

Sodermanlands Lan

ZIP/Postal Code

18158

Country

Sweden

Facility Name

Novartis Investigative Site

City

Göteborg

State/Province

Vastra Gotalands Lan

ZIP/Postal Code

SE-413 45

Country

Sweden

Facility Name

Novartis Investigative Site

City

Lund

ZIP/Postal Code

SE-221 85

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

A Study of the Efficacy and Safety of NVA237 in Patients With Moderate to Severe COPD

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A Study of the Efficacy and Safety of NVA237 in Patients With Moderate to Severe COPD

Chronic Obstructive Pulmonary Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial