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A Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus Placebo (GLOW 1)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Glycopyrronium bromide
Placebo
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, NVA, FEV1

Eligibility Criteria

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

Inclusion Criteria:

1. Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008) and:

  • Smoking history of at least 10 pack-years
  • Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value
  • Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%

Exclusion Criteria:

  1. Patients who have had a lower respiratory tract infection within 6 weeks prior to Visit 1
  2. Patients with concomitant pulmonary disease
  3. Patients with a history of asthma
  4. Any patient with lung cancer or a history of lung cancer
  5. Patients with a history of certain cardiovascular comorbid conditions
  6. Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
  7. Patients in the active phase of a supervised pulmonary rehabilitation program
  8. Patients contraindicated for tiotropium or ipratropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents 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

Placebo Comparator

Arm Label

Glycopyrronium bromide

Placebo

Arm Description

Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.

Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.

Outcomes

Primary Outcome Measures

Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks
Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.

Secondary Outcome Measures

Transition Dyspnea Index (TDI) Focal Score After 26 Weeks of Treatment
Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline. Mixed model used baseline TDI, baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.
Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Total Score After 26 Weeks of Treatment
SGRQ is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. Mixed model used baseline SGRQ, baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.
Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During 26 Weeks of Treatment
The time to the first moderate or severe COPD exacerbation was the study day on which the patient experienced first 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 treatment for moderate severity and hospitalization were required.
Change From Baseline in the Mean Number of Puffs Per Day of Rescue Medication Over the Study Duration (Baseline to Week 26)
Participants recorded the number of puffs of rescue medication taken in the previous 12 hours in the morning and evening. The total number of puffs of rescue medication per day over the full 26 weeks was calculated and divided by the total number of days with non-missing rescue medication data to derive the mean daily number of puffs of rescue medication taken for the patient.
FEV1 at Each Time-point on Day 1 and Week 26
Spirometry was conducted according to internationally accepted standards. FEV1 was measured at all time points up to 4 hours post-dose, and at 23 hours 15 min and 23 hours 45 min, by visit. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.
Forced Vital Capacity (FVC) at Each Time-point on Day 1 and Week 26
Spirometry was conducted according to internationally accepted standards. FVC was calculated at each time point up to 4 hours post-dose and at 23 hours 15 min and 23 hours 45 min, by visit. Mixed model used baseline FVC, baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.
FEV1 Area Under the Curve (AUC) (5 Min - 12 Hour) at Day 1, Week 12 and Week 26
The standardized (with respect to the length of time) area under the curve (AUC) for FEV1 was calculated using trapezoidal rule between 5 min and 12 h post dose at Week 1 Day 1, Week 12 and Week 26 for every patient in the serial spirometry subgroup. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.
FEV1 Area Under Curve (AUC) (5 Min - 23 Hour 45 Min) at Week 12 and Week 26
The standardized (with respect to the length of time) area under the curve (AUC) for FEV1 was calculated using trapezoidal rule between 5 min and 23 h 45 min post dose at week12/week 13and week 26/week 27 where available for every patient in the serial spirometry subgroup. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.
Trough FEV1 and FVC at Day 1 and Week 26
Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates. Trough FVC was defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FVC readings. Mixed model used baseline FVC, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates.
Change in 24-hourly Mean Heart Rate at Day 1, Week 12 and Week 26
The mean heart rate was collected with a 24 hour Holter monitor in a sub-set of the safety population. The change between baseline and day 1, week 12 and week 26 was calculated. The analysis of the Holter recordings was performed by a central facility. Data on heart rate, heart rate variability, supraventricular and ventricular ectopy were collected and assessed.
Number of Participants With Adverse Events, Death, and Serious or Clinically Significant Adverse Events or Related Discontinuations
Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Rate of Moderate or Severe COPD Exacerbations Over the 26 Week Treatment Period
One overall rate is calculated for the entire study population. Rate is the number of moderate or severe exacerbations per year = total number of moderate or severe exacerbations for all participants/total number of treatment years for all participants. COPD exacerbations were considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations were considered to be severe if treatment for moderate severity and hospitalization were required.
Percentage of Nights With no Nighttime Awakenings Over the 26 Week Treatment Period
The percentage of nights with no nighttime awakenings is defined as the total number of nights with no nighttime awakenings over the 26 week treatment period divided by the total number of night where diary recordings have been made. Mixed model used baseline nighttime awakenings, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates.
Percentage of Days With no Daytime Symptoms Over the 26 Week Treatment Period
The percentage of days with no daytime symptoms is defined as the total number of days with no daytime symptoms over the 26 week treatment period divided by the total number of days where diary recordings have been made. Mixed model used baseline daytime symptoms, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates.
Percentage of Days Able to Perform Usual Daily Activities Over the 26 Week Treatment Period
The percentage of days able to perform usual daily activities is defined as the total number of days able to perform usual activities over the 26 week treatment period divided by the total number of days where diary recordings have been made. Mixed model used baseline ability to perform usual daily activities, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates.
Mean Daily Total Symptom Score Over the 26 Week Treatment Period
The daily symptom score was calculated as the sum of the worst of the morning and evening assessments for each symptom (symptoms, cough, wheeze, sputum color/production, and breathlessness). The score can range from 0 to 18 with 0 indicating no symptoms. The higher the score, the worse the symptomatic status. A negative change (lower number) indicates improvement. Mixed model used baseline symptom variables, baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.

Full Information

First Posted
October 30, 2009
Last Updated
March 15, 2012
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01005901
Brief Title
A Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus Placebo
Acronym
GLOW 1
Official Title
A 26-week Treatment, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of NVA237 in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
A study to assess the safety, tolerability and efficacy of NVA237 versus placebo in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).

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, NVA, FEV1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1324 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glycopyrronium bromide
Arm Type
Experimental
Arm Description
Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
Intervention Type
Drug
Intervention Name(s)
Glycopyrronium bromide
Intervention Description
Glycopyrronium bromide 50µg was supplied as inhalation capsules for use via a Single Dose Dry Powder Inhaler (SDDPI)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo inhalation capsules were provided for use via a SDDPI
Primary Outcome Measure Information:
Title
Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks
Description
Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Transition Dyspnea Index (TDI) Focal Score After 26 Weeks of Treatment
Description
Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline. Mixed model used baseline TDI, baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.
Time Frame
26 weeks
Title
Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Total Score After 26 Weeks of Treatment
Description
SGRQ is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. Mixed model used baseline SGRQ, baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.
Time Frame
26 weeks
Title
Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During 26 Weeks of Treatment
Description
The time to the first moderate or severe COPD exacerbation was the study day on which the patient experienced first 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 treatment for moderate severity and hospitalization were required.
Time Frame
26 weeks
Title
Change From Baseline in the Mean Number of Puffs Per Day of Rescue Medication Over the Study Duration (Baseline to Week 26)
Description
Participants recorded the number of puffs of rescue medication taken in the previous 12 hours in the morning and evening. The total number of puffs of rescue medication per day over the full 26 weeks was calculated and divided by the total number of days with non-missing rescue medication data to derive the mean daily number of puffs of rescue medication taken for the patient.
Time Frame
26 weeks
Title
FEV1 at Each Time-point on Day 1 and Week 26
Description
Spirometry was conducted according to internationally accepted standards. FEV1 was measured at all time points up to 4 hours post-dose, and at 23 hours 15 min and 23 hours 45 min, by visit. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.
Time Frame
Day 1 and Week 26
Title
Forced Vital Capacity (FVC) at Each Time-point on Day 1 and Week 26
Description
Spirometry was conducted according to internationally accepted standards. FVC was calculated at each time point up to 4 hours post-dose and at 23 hours 15 min and 23 hours 45 min, by visit. Mixed model used baseline FVC, baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.
Time Frame
Day 1 and Week 26
Title
FEV1 Area Under the Curve (AUC) (5 Min - 12 Hour) at Day 1, Week 12 and Week 26
Description
The standardized (with respect to the length of time) area under the curve (AUC) for FEV1 was calculated using trapezoidal rule between 5 min and 12 h post dose at Week 1 Day 1, Week 12 and Week 26 for every patient in the serial spirometry subgroup. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.
Time Frame
Day 1, Week 12 and Week 26
Title
FEV1 Area Under Curve (AUC) (5 Min - 23 Hour 45 Min) at Week 12 and Week 26
Description
The standardized (with respect to the length of time) area under the curve (AUC) for FEV1 was calculated using trapezoidal rule between 5 min and 23 h 45 min post dose at week12/week 13and week 26/week 27 where available for every patient in the serial spirometry subgroup. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.
Time Frame
Week 12 and Week 26
Title
Trough FEV1 and FVC at Day 1 and Week 26
Description
Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates. Trough FVC was defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FVC readings. Mixed model used baseline FVC, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates.
Time Frame
Day 1 and Week 26
Title
Change in 24-hourly Mean Heart Rate at Day 1, Week 12 and Week 26
Description
The mean heart rate was collected with a 24 hour Holter monitor in a sub-set of the safety population. The change between baseline and day 1, week 12 and week 26 was calculated. The analysis of the Holter recordings was performed by a central facility. Data on heart rate, heart rate variability, supraventricular and ventricular ectopy were collected and assessed.
Time Frame
Baseline, Day 1, Week 12 and Week 26
Title
Number of Participants With Adverse Events, Death, and Serious or Clinically Significant Adverse Events or Related Discontinuations
Description
Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Time Frame
26 Weeks and 30 Day follow-up
Title
Rate of Moderate or Severe COPD Exacerbations Over the 26 Week Treatment Period
Description
One overall rate is calculated for the entire study population. Rate is the number of moderate or severe exacerbations per year = total number of moderate or severe exacerbations for all participants/total number of treatment years for all participants. COPD exacerbations were considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations were considered to be severe if treatment for moderate severity and hospitalization were required.
Time Frame
26 weeks
Title
Percentage of Nights With no Nighttime Awakenings Over the 26 Week Treatment Period
Description
The percentage of nights with no nighttime awakenings is defined as the total number of nights with no nighttime awakenings over the 26 week treatment period divided by the total number of night where diary recordings have been made. Mixed model used baseline nighttime awakenings, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates.
Time Frame
26 Weeks
Title
Percentage of Days With no Daytime Symptoms Over the 26 Week Treatment Period
Description
The percentage of days with no daytime symptoms is defined as the total number of days with no daytime symptoms over the 26 week treatment period divided by the total number of days where diary recordings have been made. Mixed model used baseline daytime symptoms, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates.
Time Frame
26 Weeks
Title
Percentage of Days Able to Perform Usual Daily Activities Over the 26 Week Treatment Period
Description
The percentage of days able to perform usual daily activities is defined as the total number of days able to perform usual activities over the 26 week treatment period divided by the total number of days where diary recordings have been made. Mixed model used baseline ability to perform usual daily activities, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates.
Time Frame
26 Weeks
Title
Mean Daily Total Symptom Score Over the 26 Week Treatment Period
Description
The daily symptom score was calculated as the sum of the worst of the morning and evening assessments for each symptom (symptoms, cough, wheeze, sputum color/production, and breathlessness). The score can range from 0 to 18 with 0 indicating no symptoms. The higher the score, the worse the symptomatic status. A negative change (lower number) indicates improvement. Mixed model used baseline symptom variables, baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.
Time Frame
26 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008) and: Smoking history of at least 10 pack-years Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value Post-bronchodilator FEV1/FVC (forced vital capacity) < 70% Exclusion Criteria: Patients who have had a lower respiratory tract infection within 6 weeks prior to Visit 1 Patients with concomitant pulmonary disease Patients with a history of asthma Any patient with lung cancer or a history of lung cancer Patients with a history of certain cardiovascular comorbid conditions Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency Patients in the active phase of a supervised pulmonary rehabilitation program Patients contraindicated for tiotropium or ipratropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents 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
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Novartis Investigative Site
City
Fairhope
State/Province
Alabama
Country
United States
Facility Name
Novartis Investigative Site
City
Glendale
State/Province
Arizona
Country
United States
Facility Name
Novartis Investigative Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Novartis Investigative Site
City
Walnut Creek
State/Province
California
Country
United States
Facility Name
Novartis Investigative Site
City
Newark
State/Province
Delaware
Country
United States
Facility Name
Novartis Investigative Site
City
Port Orange
State/Province
Florida
Country
United States
Facility Name
Novartis Investigative Site
City
Tamarac
State/Province
Florida
Country
United States
Facility Name
Novartis Investigative Site
City
Topeka
State/Province
Kansas
Country
United States
Facility Name
Novartis Investigative Site
City
Madisonville
State/Province
Kentucky
Country
United States
Facility Name
Novartis Investigative Site
City
Slidell
State/Province
Louisiana
Country
United States
Facility Name
Novartis Investigative Site
City
Biddeford
State/Province
Maine
Country
United States
Facility Name
Novartis Investigative Site
City
Pikesville
State/Province
Maryland
Country
United States
Facility Name
Novartis Investigative Site
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Novartis Investigative Site
City
Livonia
State/Province
Michigan
Country
United States
Facility Name
Novartis Investigative Site
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Novartis Investigative Site
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Novartis Investigative Site
City
St. Charles
State/Province
Missouri
Country
United States
Facility Name
Novartis Investigative Site
City
Missoula
State/Province
Montana
Country
United States
Facility Name
Novartis Investigative Site
City
Bellevue
State/Province
Nebraska
Country
United States
Facility Name
Novartis Investigative Site
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Novartis Investigative Site
City
Reno
State/Province
Nevada
Country
United States
Facility Name
Novartis Investigative Site
City
New Brunswick
State/Province
New Jersey
Country
United States
Facility Name
Novartis Investigative Site
City
Rochester
State/Province
New York
Country
United States
Facility Name
Novartis Investigative Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Novartis Investigative Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Novartis Investigative Site
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
Novartis Investigative Site
City
Lincoln
State/Province
Rhode Island
Country
United States
Facility Name
Novartis Investigative Site
City
Johnson City
State/Province
Tennessee
Country
United States
Facility Name
Novartis Investigative Site
City
Corpus Christi
State/Province
Texas
Country
United States
Facility Name
Novartis Investigative Site
City
McKinney
State/Province
Texas
Country
United States
Facility Name
Novartis Investigative Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Novartis Investigative Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Novartis Investigative Site
City
Daw Park SA
Country
Australia
Facility Name
Novartis Investigative Site
City
Bridgewater
State/Province
Nova Scotia
Country
Canada
Facility Name
Novartis Investigative Site
City
Courtice
State/Province
Ontario
Country
Canada
Facility Name
Novartis Investigative Site
City
Mississuaga
State/Province
Ontario
Country
Canada
Facility Name
Novartis Investigative Site
City
North York
State/Province
Ontario
Country
Canada
Facility Name
Novartis Investigative Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Novartis Investigative Site
City
Asahikawa
Country
Japan
Facility Name
Novartis Investigative Site
City
Hamakita
Country
Japan
Facility Name
Novartis Investigative Site
City
Himeji
Country
Japan
Facility Name
Novartis Investigative Site
City
Hitachi
Country
Japan
Facility Name
Novartis Investigative Site
City
Kishiwada
Country
Japan
Facility Name
Novartis Investigative Site
City
Kyoto
Country
Japan
Facility Name
Novartis Investigative Site
City
Matsue
Country
Japan
Facility Name
Novartis Investigative Site
City
Matsusaka
Country
Japan
Facility Name
Novartis Investigative Site
City
Moriya
Country
Japan
Facility Name
Novartis Investigative Site
City
Naka-gun
Country
Japan
Facility Name
Novartis Investigative Site
City
Obihiro
Country
Japan
Facility Name
Novartis Investigative Site
City
Osaka
Country
Japan
Facility Name
Novartis Investigative Site
City
Ota
Country
Japan
Facility Name
Novartis Investigative Site
City
Otsu
Country
Japan
Facility Name
Novartis Investigative Site
City
Sapporo
Country
Japan
Facility Name
Novartis Investigative Site
City
Takatsuki
Country
Japan
Facility Name
Novartis Investigative Site
City
Tokyo
Country
Japan
Facility Name
Novartis Investigative Site
City
Yabu
Country
Japan
Facility Name
Novartis Investigative Site
City
Yonezawa
Country
Japan
Facility Name
Novartis Investigative Site
City
Daegu
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Pusan
Country
Korea, Republic of
Facility Name
Novartis Investigative site
City
Seoul
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Almelo
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Eindhoven
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Harderwijk
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Heerlen
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Zutphen
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Bucharest
Country
Romania
Facility Name
Novartis Investigative Site
City
Bucuresti
Country
Romania
Facility Name
Novartis Investigative Site
City
Iasi
Country
Romania
Facility Name
Novartis Investigative Site
City
Timisoara
Country
Romania
Facility Name
Novartis Investigative Site
City
Irkutsk
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Kazan
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Krasnodar
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
N. Novgorod
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Novosibirsk
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Sochy
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Stavropol
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Yaroslavl
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Singapore
Country
Singapore
Facility Name
Novartis Investigative Site
City
Alicante
Country
Spain
Facility Name
Novartis Investigative Site
City
Badalona
Country
Spain
Facility Name
Novartis Investigative Site
City
Caceres
Country
Spain
Facility Name
Novartis Investigative Site
City
Canet de Mar
Country
Spain
Facility Name
Novartis Investigative Site
City
Centelles
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
Country
Spain
Facility Name
Novartis Investigative Site
City
Altunizade
Country
Turkey
Facility Name
Novartis Investigative Site
City
Aydin
Country
Turkey
Facility Name
Novartis Investigative Site
City
Diyarbakir
Country
Turkey
Facility Name
Novartis Investigative Site
City
Istanbul
Country
Turkey
Facility Name
Novartis Investigative Site
City
Izmir
Country
Turkey
Facility Name
Novartis Investigative Site
City
Kinikli/Denizli
Country
Turkey
Facility Name
Novartis Investigative Site
City
Mersin
Country
Turkey
Facility Name
Novartis Investigative Site
City
Soke/Aydin
Country
Turkey
Facility Name
Novartis Investigative Site
City
Yenisehir/Izmir
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
22151296
Citation
D'Urzo A, Ferguson GT, van Noord JA, Hirata K, Martin C, Horton R, Lu Y, Banerji D, Overend T. Efficacy and safety of once-daily NVA237 in patients with moderate-to-severe COPD: the GLOW1 trial. Respir Res. 2011 Dec 7;12(1):156. doi: 10.1186/1465-9921-12-156.
Results Reference
result
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

Learn more about this trial

A Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus Placebo

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