Back to results

1-year Study to Assess the Efficacy, Safety, and Tolerability of Glycopyrronium Bromide (NVA237) in Chronic Obstructive Pulmonary Disease (COPD) (GLOW2)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Glycopyrronium bromide

Placebo to glycopyrronium bromide

Tiotropium

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, NVA237, glycopyrronium bromide

Eligibility Criteria

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

Inclusion Criteria:

Male or female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
Patients with moderate to severe stable chronic obstructive pulmonary disease (COPD, Stage II or Stage III) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines 2008.
Current or ex-smokers who have a smoking history of at least 10 pack years.
Patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30% and < 80% of the predicted normal, and post-bronchodilator FEV1/forced vital capacity (FVC) < 0.7 at Visit 2 (Day -14).
Patients, according to daily electronic diary data between Visit 2 (Day -14) and Visit 3 (Day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to Visit 3 (Day 1).

Exclusion Criteria:

Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test).
Women of child-bearing potential, unless using an approved method of medical or surgical contraception.
Patients requiring long term oxygen therapy (> 15 h a day) on a daily basis for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 1 (Day -21) or between Visit 1 (Day -21) and Visit 3 (Day 1).
Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1 (Day -21).
Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition.
Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 600/mm^3 (at Visit 1, Day -21) and onset of symptoms prior to age 40 years.
Patients with a history of long QT syndrome or whose QTc measured at Visit 1 (Day -21) (Fridericia method) is prolonged (> 450 ms for males or > 470 ms for females.

Other protocol-defined inclusion/exclusion criteria may apply to the study.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Glycopyrronium bromide 50 μg

Placebo to glycopyrronium bromide

Tiotropium 18 μg

Arm Description

Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Outcomes

Primary Outcome Measures

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

FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose. The analysis included baseline FEV1 measurement, baseline inhaled corticosteroid use (Yes/No), FEV1 prior to inhalation of short-acting β2 agonist (SABA), and FEV1 45 min post-inhalation of SABA as covariates.

Secondary Outcome Measures

Transition Dyspnea Index (TDI) at Week 26

The TDI measured changes in dyspnea from baseline during treatment and included 3 domains: Functional impairment (activities of daily living), magnitude of task (intensity of activity), and magnitude of effort (difficulty breathing). Each domain was rated from -3 to 3 (major deterioration-major improvement). The total score ranged from -9 to 9; minus scores indicate deterioration. The analysis included the same covariates as the primary Outcome Measure.

Health-related Quality of Life (QoL) Assessed With the St. George Respiratory Questionnaire (SGRQ) at Week 52

The SGRQ contained 51 patient-rated items divided into three components: Symptoms (respiratory symptoms, their frequency, and severity), Activity (activities that cause or are limited by breathlessness), and Impacts (social functioning and psychological disturbances resulting from airway disease). A total score for the 3 components was calculated and ranged from 0 to 100. Higher values indicate greater impairment of QoL. The analysis included the same covariates as the primary Outcome Measure.

Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the Study (Baseline to Week 52)

Time to first moderate or severe COPD exacerbation was calculated as the number of days from baseline to the day on which the patient experienced the first moderate or severe COPD exacerbation. A COPD exacerbation was considered to be moderate if treatment with systemic corticosteroids and/or antibiotic was required. A COPD exacerbation was considered to be severe if treatment for moderate severity and hospitalization was required.

Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Taken During the Study (Baseline to Week 52)

The number of puffs of rescue medication taken in the previous 12 hours was recorded in the Patient Diary in the morning and evening. The mean daily number of puffs of rescue medication taken was calculated by dividing the number of puffs of rescue medication per day over the 52 weeks of the study by the number of days with non-missing rescue medication data. Rescue medication data recorded during the 14 day run-in period was used to calculate the baseline. The analysis included the same covariates as the primary Outcome Measure. A positive change score indicates more puffs taken.

Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1, Week 26, and Week 52

Trough Forced Vital Capacity (FVC) at Day 1, Week 12, Week 26, and Week 52

Trough FVC is defined as the average of the post-dose 23 h 15 min and the 23 h 45 min FVC values. Just prior to FVC measurement, patients performed normal tidal breathing. The patient was given a few breaths warning before being told "At the end of the next normal breath out, take a deep breath all the way in"; they were then verbally encouraged to make a maximal effort before relaxing. The analysis included the same covariates as the primary Outcome Measure.

Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52

FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks.

Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52

Just prior to FVC measurement, patients performed normal tidal breathing. The patient was given a few breaths warning before being told "At the end of the next normal breath out, take a deep breath all the way in"; they were then verbally encouraged to make a maximal effort before relaxing. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks.

Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52

Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52

Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at Day 1 and Weeks 12, 26, and 52

FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 3, and 4 hours post-dose. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included the same covariates as the primary Outcome Measure.

Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours Post-dose at Day 1 and Weeks 12 and 52

FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 3, 4, 6, 8 10, and 12 hours post-dose. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included the same covariates as the primary Outcome Measure.

Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 23 Hours 45 Minutes and From 12 Hours to 23 Hours 45 Minutes Post-dose at Weeks 12 and 52

FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; 1, 2, 3, 4, 6, 8, 10, and 12 hours; 23 hours 15 minutes; and 23 hours 45 minutes post-dose. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included the same covariates as the primary Outcome Measure.

Number of Moderate or Severe Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) Per Year During the Study (Baseline to Week 52)

The number of moderate or severe exacerbations of COPD per year during the study was calculated by dividing the total number of exacerbations during the study by the total number of years of treatment. A COPD exacerbation was considered to be moderate if treatment with systemic corticosteroids and/or antibiotic was required. A COPD exacerbation was considered to be severe if treatment for moderate severity and hospitalization was required.

Percentage of Patients Who Experienced a Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the Study (Baseline to Week 52)

A COPD exacerbation was considered to be moderate if treatment with systemic corticosteroids and/or antibiotic was required. A COPD exacerbation was considered to be severe if treatment for moderate severity and hospitalization was required.

Percentage of Nights With "no Nighttime Awakenings" During the Study (Baseline to Week 52)

A night with "no nighttime awakenings" was defined as any night where the patient did not wake up due to 1 or more of 6 symptoms (respiratory symptoms, cough, wheeze, amount of sputum, color of sputum, and breathlessness). Symptoms occurring during the previous 12 hours were recorded each morning and evening by the patient in an electronic diary. The percentage of nights with 'no nighttime awakenings' was calculated as the total number of nights with "no nighttime awakenings" over the 52 week treatment period divided by the total number of nights where diary recordings were made.

Percentage of Days With "no Daytime Symptoms" During the Study (Baseline to Week 52)

A day with "no daytime symptoms" was defined as any day where the patient recorded no cough, no wheeze, no production of sputum, no feeling of breathlessness (other than when running), and no puffs of rescue medication during the previous 12 hours in evening entry in the electronic patient diary. The percentage of days with "no daytime symptoms" was calculated as the total number of days with "no daytime symptoms" over the 52 week treatment period divided by the total number of days where diary recordings were made.

Percentage of "Days Able to Perform Usual Daily Activities" During the Study (Baseline to Week 52)

A "day able to perform usual daily activities" was defined as any day where the patient recorded in their electronic diary in the evening that they were not prevented from performing their usual daily activities due to respiratory symptoms during the previous 12 hours. The percentage of "days able to perform usual daily activities" was calculated as the total number of "days able to perform usual daily activities" over the 52 week treatment period divided by the total number of days where diary recordings were made.

Change From Baseline in the Mean Daily Total Symptom Score During the Study (Baseline to Week 52)

The daily total symptom score was defined as the sum of the morning and evening patient self-reported diary assessments of 6 symptoms (respiratory symptoms/impact on daily activities, cough, wheeze, amount of sputum, color of sputum, and breathlessness). Means for baseline (14 day maximum run-in period) and the 52 week treatment period were calculated. Mean scores ranged from 0-18, with a higher score indicating worse symptoms. A negative change score indicated improvement.

Full Information

NCT ID

NCT00929110

First Posted

June 25, 2009

Last Updated

August 9, 2012

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00929110

Brief Title

1-year Study to Assess the Efficacy, Safety, and Tolerability of Glycopyrronium Bromide (NVA237) in Chronic Obstructive Pulmonary Disease (COPD)

Acronym

GLOW2

Official Title

A 52-week Treatment, Randomized, Double-blind, Placebo-controlled, With Open-label Tiotropium, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Glycopyrronium Bromide (NVA237) in Patients With Chronic Obstructive Pulmonary Disease

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis

4. Oversight

5. Study Description

Brief Summary

This study was designed to investigate the 1 year efficacy and safety of the 50 µg once daily (od) dose of glycopyrronium bromide (NVA237) in patients with moderate to severe chronic obstructive pulmonary disease.

6. Conditions and Keywords

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

Chronic Obstructive Pulmonary Disease

Keywords

COPD, NVA237, glycopyrronium bromide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

1066 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Glycopyrronium bromide 50 μg

Arm Type

Experimental

Arm Description

Arm Title

Placebo to glycopyrronium bromide

Arm Type

Placebo Comparator

Arm Description

Arm Title

Tiotropium 18 μg

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Glycopyrronium bromide

Other Intervention Name(s)

NVA237

Intervention Description

Glycopyrronium bromide was supplied in powder-filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Intervention Type

Drug

Intervention Name(s)

Placebo to glycopyrronium bromide

Intervention Description

Placebo to glycopyrronium bromide was supplied in powder-filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Intervention Type

Drug

Intervention Name(s)

Tiotropium

Intervention Description

Tiotropium was supplied in powder-filled capsules together with the Handihaler® device.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Transition Dyspnea Index (TDI) at Week 26

Description

Time Frame

Week 26

Title

Health-related Quality of Life (QoL) Assessed With the St. George Respiratory Questionnaire (SGRQ) at Week 52

Description

Time Frame

Week 52

Title

Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the Study (Baseline to Week 52)

Description

Time Frame

Baseline to Week 52 (patients with no moderate or severe exacerbations who completed the study were censored at the final visit date, which may have exceeded 52 weeks)

Title

Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Taken During the Study (Baseline to Week 52)

Description

Time Frame

Baseline to Week 52

Title

Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1, Week 26, and Week 52

Description

Time Frame

Day 1, Week 26, and Week 52

Title

Trough Forced Vital Capacity (FVC) at Day 1, Week 12, Week 26, and Week 52

Description

Time Frame

Day 1, Week 12, Week 26, and Week 52

Title

Description

Time Frame

5, 15, and 30 minutes; 1, 2, 3, 4, 6, 8, 10, and 12 hours; 23 hours 15 minutes; and 23 hours 45 minutes post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52

Title

Description

Time Frame

5, 15, and 30 minutes; 1, 2, 3, 4, 6, 8, 10, and 12 hours; 23 hours 15 minutes; and 23 hours 45 minutes post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52

Title

Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52

Description

Time Frame

5, 15, and 30 minutes; and 1, 2, 3, 4 hours post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52

Title

Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52

Description

Time Frame

5, 15, and 30 minutes; and 1, 2, 3, 4 hours post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52

Title

Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at Day 1 and Weeks 12, 26, and 52

Description

Time Frame

From 5 minutes to 4 hours post-dose at Day 1 and Weeks 12, 26, and 52

Title

Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours Post-dose at Day 1 and Weeks 12 and 52

Description

Time Frame

From 5 minutes to 12 hours post-dose at Day 1 and Weeks 12 and 52

Title

Description

Time Frame

From 5 minutes to 23 hours 45 minutes post-dose at Weeks 12 and 52

Title

Number of Moderate or Severe Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) Per Year During the Study (Baseline to Week 52)

Description

Time Frame

Baseline to Week 52

Title

Percentage of Patients Who Experienced a Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the Study (Baseline to Week 52)

Description

Time Frame

Baseline to Week 52

Title

Percentage of Nights With "no Nighttime Awakenings" During the Study (Baseline to Week 52)

Description

Time Frame

Baseline to Week 52

Title

Percentage of Days With "no Daytime Symptoms" During the Study (Baseline to Week 52)

Description

Time Frame

Baseline to Week 52

Title

Percentage of "Days Able to Perform Usual Daily Activities" During the Study (Baseline to Week 52)

Description

Time Frame

Baseline to Week 52

Title

Change From Baseline in the Mean Daily Total Symptom Score During the Study (Baseline to Week 52)

Description

Time Frame

Baseline to Week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure. Patients with moderate to severe stable chronic obstructive pulmonary disease (COPD, Stage II or Stage III) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines 2008. Current or ex-smokers who have a smoking history of at least 10 pack years. Patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30% and < 80% of the predicted normal, and post-bronchodilator FEV1/forced vital capacity (FVC) < 0.7 at Visit 2 (Day -14). Patients, according to daily electronic diary data between Visit 2 (Day -14) and Visit 3 (Day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to Visit 3 (Day 1). Exclusion Criteria: Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test). Women of child-bearing potential, unless using an approved method of medical or surgical contraception. Patients requiring long term oxygen therapy (> 15 h a day) on a daily basis for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 1 (Day -21) or between Visit 1 (Day -21) and Visit 3 (Day 1). Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1 (Day -21). Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition. Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 600/mm^3 (at Visit 1, Day -21) and onset of symptoms prior to age 40 years. Patients with a history of long QT syndrome or whose QTc measured at Visit 1 (Day -21) (Fridericia method) is prolonged (> 450 ms for males or > 470 ms for females. Other protocol-defined inclusion/exclusion criteria may apply to the study.

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

Birmingham

State/Province

Alabama

ZIP/Postal Code

35249

Country

United States

Facility Name

Novartis Investigative Site

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Novartis Investigative Site

City

Montgomery

State/Province

Alabama

ZIP/Postal Code

36117

Country

United States

Facility Name

Novartis Investigator Site

City

Fort Smith

State/Province

Arkansas

ZIP/Postal Code

72901

Country

United States

Facility Name

Novartis Investigator Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Novartis Investigative Site

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Novartis Investigative Site

City

Lakewood

State/Province

California

ZIP/Postal Code

90712-151

Country

United States

Facility Name

Novartis Investigator Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

Facility Name

Novartis Investigator Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Novartis Investigator Site

City

Mission Viejo

State/Province

California

ZIP/Postal Code

92691

Country

United States

Facility Name

Novartis Investigator Site

City

Paramount

State/Province

California

ZIP/Postal Code

90723

Country

United States

Facility Name

Novartis Investigator Site

City

Riverside

State/Province

California

ZIP/Postal Code

92506

Country

United States

Facility Name

Novartis Investigative Site

City

Rolling Hills Estates

State/Province

California

ZIP/Postal Code

90274

Country

United States

Facility Name

Novartis Investigator Site

City

San Diego

State/Province

California

ZIP/Postal Code

92120

Country

United States

Facility Name

Novartis Investigator Site

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80907

Country

United States

Facility Name

Novartis Investigative site

City

DeLand

State/Province

Florida

ZIP/Postal Code

32720

Country

United States

Facility Name

Novartis Investigative Site

City

Ft. Lauderdale

State/Province

Florida

ZIP/Postal Code

33316-192

Country

United States

Facility Name

Novartis Investigative Site

City

Miami Beach

State/Province

Florida

ZIP/Postal Code

33140

Country

United States

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33186

Country

United States

Facility Name

Novartis Investigative Site

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

Novartis Investigative Site

City

Panama City

State/Province

Florida

ZIP/Postal Code

32405

Country

United States

Facility Name

Novartis Investigative Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Facility Name

Novartis Investigator Site

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32789

Country

United States

Facility Name

Novartis Investigative Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Novartis Investigative Site

City

Blue Ridge

State/Province

Georgia

ZIP/Postal Code

30513

Country

United States

Facility Name

Novartis Investigative Site

City

Duluth

State/Province

Georgia

ZIP/Postal Code

30096

Country

United States

Facility Name

Novartis Investigator Site

City

Coeur D'Alene

State/Province

Idaho

ZIP/Postal Code

83814

Country

United States

Facility Name

Novartis Investigator Site

City

Skokie

State/Province

Illinois

ZIP/Postal Code

60076

Country

United States

Facility Name

Novartis Investigator Site

City

New Albany

State/Province

Indiana

ZIP/Postal Code

47150-3054

Country

United States

Facility Name

Novartis Investigator Site

City

Valparaiso

State/Province

Indiana

ZIP/Postal Code

46383

Country

United States

Facility Name

Novartis Investigator Site

City

Council Bluffs

State/Province

Iowa

ZIP/Postal Code

51503-4658

Country

United States

Facility Name

Novartis Investigator Site

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52240

Country

United States

Facility Name

Novartis Investigator Site

City

Shawnee

State/Province

Kansas

ZIP/Postal Code

66216-1800

Country

United States

Facility Name

Novartis Investigative Center

City

Crescent Springs

State/Province

Kentucky

ZIP/Postal Code

41017

Country

United States

Facility Name

Novartis Investigative Site

City

Crestview Hills

State/Province

Kentucky

ZIP/Postal Code

41017-542

Country

United States

Facility Name

Novartis Investigative Site

City

Hazard

State/Province

Kentucky

ZIP/Postal Code

41701

Country

United States

Facility Name

Novartis Investigative Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40215

Country

United States

Facility Name

Novartis Investigator Site

City

Lafayette

State/Province

Louisiana

ZIP/Postal Code

70508

Country

United States

Facility Name

Novartis Investigator Site

City

Sunset

State/Province

Louisiana

ZIP/Postal Code

70584

Country

United States

Facility Name

Novartis Investigator Site

City

Boys Town

State/Province

Maine

ZIP/Postal Code

68010

Country

United States

Facility Name

Novartis Investigative Site

City

Columbia

State/Province

Maryland

ZIP/Postal Code

21044

Country

United States

Facility Name

Novartis Investigative Site

City

Wheaton

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

Facility Name

Novartis Investigative Site

City

North Dartmouth

State/Province

Massachusetts

ZIP/Postal Code

02747

Country

United States

Facility Name

Novartis Investigative Site

City

Taunton

State/Province

Massachusetts

ZIP/Postal Code

02780

Country

United States

Facility Name

Novartis Investigator Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55402

Country

United States

Facility Name

Novartis Investigator Site

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63122

Country

United States

Facility Name

Novartis Investigator Site

City

Bozeman

State/Province

Montana

ZIP/Postal Code

59718

Country

United States

Facility Name

Novartis Investigator Site

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68510

Country

United States

Facility Name

Novartis Investigator Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131-2197

Country

United States

Facility Name

Novartis Investigator Site

City

Papillion

State/Province

Nebraska

ZIP/Postal Code

68046

Country

United States

Facility Name

Novartis Investigative Site

City

Skillman

State/Province

New Jersey

ZIP/Postal Code

08558

Country

United States

Facility Name

Novartis Investigative Site

City

Endwell

State/Province

New York

ZIP/Postal Code

13760

Country

United States

Facility Name

Novartis Investigative site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Facility Name

Novartis Investigator Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45245

Country

United States

Facility Name

Novartis Investigator Site

City

Sylvania

State/Province

Ohio

ZIP/Postal Code

43560

Country

United States

Facility Name

Novartis Investigator Site

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43614

Country

United States

Facility Name

Novartis Investigator Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Novartis Investigator Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Novartis Investigator Site

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504-8741

Country

United States

Facility Name

Novartis Investigator Site

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Novartis Investigator Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

92713

Country

United States

Facility Name

Novartis Investigator Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97213

Country

United States

Facility Name

Novartis Investigative Site

City

Downingtown

State/Province

Pennsylvania

ZIP/Postal Code

19335-2620

Country

United States

Facility Name

Novartis Investigative Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19115

Country

United States

Facility Name

Novartis Investigative Site

City

East Providence

State/Province

Rhode Island

ZIP/Postal Code

02914

Country

United States

Facility Name

Novartis Investigative Site

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02906

Country

United States

Facility Name

Novartis Investigative Site

City

North Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

Novartis Investigator Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78750

Country

United States

Facility Name

Novartis Investigator Site

City

El Paso

State/Province

Texas

ZIP/Postal Code

79902

Country

United States

Facility Name

Novartis Investigator Site

City

New Braunfels

State/Province

Texas

ZIP/Postal Code

78130-6113

Country

United States

Facility Name

Novartis Investigator Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Novartis Investigator Site

City

Provo

State/Province

Utah

ZIP/Postal Code

84604-1584

Country

United States

Facility Name

Novartis Investigative Site

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Facility Name

Novartis Investigator Site

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405-4266

Country

United States

Facility Name

Novartis Investigator Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53209

Country

United States

Facility Name

Novartis Investigative Site

City

Buenos Aires

Country

Argentina

Facility Name

Novartis Investigative Site

City

Capital Federal

Country

Argentina

Facility Name

Novartis Investigative Site

City

La Plata - Bueno Aire

Country

Argentina

Facility Name

Novartis Investigative Site

City

Parana Entre Rios

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

Country

Argentina

Facility Name

Novartis Investigative Site

City

Tucuman

Country

Argentina

Facility Name

Novartis Investigator Site

City

Brampton

Country

Canada

Facility Name

Novartis Investigator Site

City

Calgary

Country

Canada

Facility Name

Novartis Investigator Site

City

Edmonton

Country

Canada

Facility Name

Novartis Investigator Site

City

Kelowna

Country

Canada

Facility Name

Novartis Investigator Site

City

Langley

Country

Canada

Facility Name

Novartis Investigator Site

City

Niagara Falls

Country

Canada

Facility Name

Novartis Investigator Site

City

Quebec

Country

Canada

Facility Name

Novartis Investigator Site

City

Ste-Foy

Country

Canada

Facility Name

Novartis Investigative Site

City

Santiago

Country

Chile

Facility Name

Novartis Investigative Site

City

Talcahuano

Country

Chile

Facility Name

Novartis Investigative Site

City

Vina del Mar

Country

Chile

Facility Name

Novartis Investigative Site

City

Dijon

Country

France

Facility Name

Novartis Investigative Site

City

Paris

Country

France

Facility Name

Novartis Investigative Site

City

Rennes Cedex

Country

France

Facility Name

Novartis Investigative Site

City

Berlin

Country

Germany

Facility Name

Novartis Investigative Site

City

Landsberg

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

Country

Germany

Facility Name

Novartis Investigative Site

City

Munich

Country

Germany

Facility Name

Novartis Investigative Site

City

Gyonsyos

Country

Hungary

Facility Name

Novartis Investigative Site

City

Siokok

Country

Hungary

Facility Name

Novartis Investigative Site

City

Be'er Sheva

Country

Israel

Facility Name

Novartis Investigative Site

City

Haifa

Country

Israel

Facility Name

Novartis Investigative Site

City

Jerusalem

Country

Israel

Facility Name

Novartis Investigative Site

City

Kfar Saba

Country

Israel

Facility Name

Novartis Investigative Site

City

Rehovot

Country

Israel

Facility Name

Novartis Investigative Site

City

Firenze

Country

Italy

Facility Name

Novartis Investigative Site

City

Monza

Country

Italy

Facility Name

Novartis Investigative Site

City

Parma

Country

Italy

Facility Name

Novartis Investigative Site

City

Busan

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Gyeonggi-go

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Incheon

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Guadalajara

Country

Mexico

Facility Name

Novartis Investigative Site

City

Monterrey

Country

Mexico

Facility Name

Novartis Investigative Site

City

San Luis Potosi

Country

Mexico

Facility Name

Novartis Investigative Site

City

Sneek

Country

Netherlands

Facility Name

Novartis Investigator Site

City

Auckland

Country

New Zealand

Facility Name

Novartis Investigator Site

City

Christchurch

Country

New Zealand

Facility Name

Novartis Investigator Site

City

Hamilton

Country

New Zealand

Facility Name

Novartis Investigator Site

City

Tauranga

Country

New Zealand

Facility Name

Novartis Investigator Site

City

Wellington

Country

New Zealand

Facility Name

Novartis Investigative Site

City

Lima

Country

Peru

Facility Name

Novartis Investigative Site

City

Santiago de Surco

Country

Peru

Facility Name

Novartis Investigative Site

City

Bialystok

Country

Poland

Facility Name

Novartis Investigative Site

City

Bydgoszcz

Country

Poland

Facility Name

Novartis Investigative Site

City

Bystra

Country

Poland

Facility Name

Novartis Investigative Site

City

Gdansk

Country

Poland

Facility Name

Novartis Investigative Site

City

Krakow

Country

Poland

Facility Name

Novartis Investigative Site

City

Ostrow Wielkopolski

Country

Poland

Facility Name

Novartis Investigative Site

City

Piekary Slaskic

Country

Poland

Facility Name

Novartis Investigative Site

City

Tarnow

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

Country

Poland

Facility Name

Novartis Investigative Site

City

Barnaul

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Irkutsk

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Smolensk

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Volgograd

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Yaroslavl

Country

Russian Federation

12. IPD Sharing Statement

Citations:

PubMed Identifier

24156566

Citation

D'Urzo A, Kerwin E, Overend T, D'Andrea P, Chen H, Goyal P. Once daily glycopyrronium for the treatment of COPD: pooled analysis of the GLOW1 and GLOW2 studies. Curr Med Res Opin. 2014 Mar;30(3):493-508. doi: 10.1185/03007995.2013.858618. Epub 2013 Nov 19.

Results Reference

derived

PubMed Identifier

23060624

Citation

Kerwin E, Hebert J, Gallagher N, Martin C, Overend T, Alagappan VK, Lu Y, Banerji D. Efficacy and safety of NVA237 versus placebo and tiotropium in patients with COPD: the GLOW2 study. Eur Respir J. 2012 Nov;40(5):1106-14. doi: 10.1183/09031936.00040712. Epub 2012 Jul 26.

Results Reference

derived

Learn more about this trial

1-year Study to Assess the Efficacy, Safety, and Tolerability of Glycopyrronium Bromide (NVA237) in Chronic Obstructive Pulmonary Disease (COPD)

We'll reach out to this number within 24 hrs

1-year Study to Assess the Efficacy, Safety, and Tolerability of Glycopyrronium Bromide (NVA237) in Chronic Obstructive Pulmonary Disease (COPD) (GLOW2)

Chronic Obstructive Pulmonary Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

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