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NVA237 BID Versus Placebo Twelve-week Efficacy Study

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

NVA237

Placebo

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

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

3. Current or ex-smokers with at least 10 cigarette pack years smoking history.

Exclusion criteria:

Patients with a history of long QT syndrome, with a prolonged QTc measured during screening, or patients who have a clinically significant ECG abnormality at screening.
History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
Pregnant or nursing (lactating) women. Women of childbearing potential unless using an effective method of contraception.
Patients who in the judgment of the investigator, would be at potential risk if enrolled into the study.
Patients who have a clinically significant concomitant disease at screening, including but not limited to clinically significant laboratory abnormalities, clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities, or with uncontrolled diabetes, which could interfere with the assessment of the efficacy and safety of the study treatment.
Patients with a body mass index (BMI) of more than 40 kg/m2.
Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to anticholinergic agents, long and short acting beta-2 agonists, or sympathomimetic amines.
Patients with any history of asthma, with onset of symptoms prior to age 40 years, or patients with a high blood eosinophil count during screening.

Other protocol-defnied inclusion/exclusion criteria may apply.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NVA237

Placebo

Arm Description

NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks

Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks

Outcomes

Primary Outcome Measures

Change From Baseline in Standardized Area Under the Curve for Forced Expiratory Volume in One Second Post Dosing

The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) post dosing (FEV1 AUC) is measured at week 12 of treatment. Serial lung function measurements are taken at the following time points following dosing at week 12 to calculate the FEV1 AUC: 5 min, 15 min, 1:00 h, 2:00 h, 4:00 h, 6:00 h, 8:00 h, and 11:55 h after the morning dose. The primary endpoint was the change from baseline in FEV1 AUC0-12h following the morning dose at Week 12 (defined as the mean FEV1 change from baseline (CFB) over 5 min to 11 h 55 mins divided by 11 h 50 mins). Where the FEV1 AUC is smaller than at baseline, a negative value can occur

Secondary Outcome Measures

Change From Baseline in Standardized Area Under the Curve (AUC(0-12h)) for Forced Expiratory Volume in One Second Post Dosing

The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) post dosing (FEV1 AUC) is assessed at day 1 of treatment. Serial lung function measurements are taken at the following various time points post dosing at day 1 to calculate the FEV1 AUC: 5 min, 15 min, 1:00 h, 2:00 h, 4:00 h, 6:00 h, 8:00 h, and 11:55 h after the morning dose. .The endpoint was the change from baseline (CFB) in FEV1 AUC0-12h following the morning dose at day 1 (defined as the mean FEV1 change from baseline over 5 min to 11 h 55 mins divided by 11 h 50 mins). Where the FEV1 AUC is smaller than at baseline, a negative value can occur.

Change From Baseline in Standardized Area Under The Curve for Forced Expiratory Volume in One Second for Different Time Spans Post Dosing

The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1FEV1) is assessed for different time spans (0-4 h, 4-8 h, 8-12 h) within the overall serial measurement post dosing (FEV1 AUCs Time Spans), at day 1 and at week 12 of treatment. Serial lung function measurements are taken at various the following time points post dosing on day 1 and at week 12 to calculate the FEV1 AUC for these different time spans: .5 min, 15 min, 1:00 h, 2:00 h, 4:00 h, 6:00 h, 8:00 h, and 11:55 h after the morning dose. The endpoint was the change from baseline (CFB) in FEV1 AUC0-12h following the morning dose at day 1 or week 12, respectively, (defined as the mean FEV1 change from baseline over 5 min to 11 h 55 mins divided by 11 h 50 mins). Where the FEV1 AUC is smaller than at baseline, a negative value can occur.

Change From Baseline in Forced Expiratory Volume in One Second at All Individual Timepoints

The Forced Expiratory Volume in one second (FEV1) assessments for all individual time points of the serial measurements on day 1 and at week 12 are analyzed. Time points of the serial lung function measurements are 5 min, 15 min, 1:00 h, 2:00 h, 4:00 h, 6:00 h, 8:00 h, and 11:55 h after the morning dose. The table indicates the percent change from baseline (CFB) in FEV1 and standard deviation in brackets. Where the FEV1 is lower than at baseline, a negative percent value can occur.

Mean Trough Forced Expiratory Volume in One Second

Mean trough Forced Expiratory Volume in one second (FEV1) is assessed as the arithmetic mean of two FEV1 measurements, conducted within the last hour of a 24 hour period from a morning dose, either that of day 1 or at week 12 of treatment. The data is reported as the change from baseline (CFB), with the baseline being the arithmetic mean of the two pre-dose measurements (-45 min and -15 min) preceding the serial lung function measurements on Day 1

Change From Baseline in the Health Status Assessed by St. George's Respiratory Questionnaire

The health status, as reported by the patients, is assessed using the St. George's Respiratory Questionnaire (SGRQ). The SGRQ is a 50 item scale assessing symptoms, patient activities and impact of the disease. Scores range from 0 to 100 units, with higher scores indicating more limitations. The assessment is based on total score as well as the percentage of patients with clinically significant improvement at week 12 versus day 1. A clinically meaningful improvement (MCID) in SGRQ is defined as a decrease of 4 or more units of the SGRQ scale in the total score, as compared to baseline (change from baseline).

Breathlessness Assessed by Transition Dyspnea Index

Breathlessness at week 12 is measured using the interviewer-administered Transition Dyspnea Index (TDI). On day 1, breathlessness is assessed by the interviewer-administered Baseline Dyspnea Index (BDI). The change from BDI to TDI is assessed, with the TDI total score ranging from -9 to +9 units of the scale. The lower the score, the more deterioration in severity of dyspnea. Patients are considered to have clinically significant improvement (MCID) with the TDI score change versus BDI being equal to or greater than 1.

Change From Baseline in Mean Number of Puffs of Rescue Medication Per Day

Patients report the number of puffs of rescue medication (salbutamol / albuterol) using an electronic diary. The use of rescue medication is analyzed as the change from baseline in the mean daily number of puffs used per patient over the 12 weeks treatment period. The baseline is calculated from the run-in epoch prior to randomization (mean number of puffs per day). A negative number indicates a reduction in the mean daily number of puffs of rescue medication.

Change From Baseline in the Percentage of Days Without Rescue Medication Use

Patients report the number of puffs of rescue medication (salbutamol / albuterol) using an electronic diary. The use of rescue medication is analyzed as the change from baseline in the percentage of days without usage of rescue medication over the 12 weeks treatment period. The baseline is calculated as the percentage of days without usage of rescue medication from during the the run-in epoch prior to randomization.

Change From Baseline in Daily Symptom Scores

Patients are reporting symptoms by using an electronic diary. The electronic diary has 9 symptom questions each morning and each evening. Each question can be answered with one of four pre-defined answers, corresponding to a unit value of 0-3, where 0 stands for the lowest and 3 for the most severe symptom experience. Symptom scores are calculated as the mean of the combined daily symptom scores (combined from morning and evening scores) for each patient over 12 weeks (Day 1 to week 12). The baseline is calculated from the run-in epoch prior to randomization. The change from baseline in the least squares mean daily symptom scores over the 12 week treatment period is provided. Where the mean daily symptom score over the 12 week treatment period is lower than the baseline, the result is negative. A negative result indicates an improvement in COPD symptom severity.

Change From Baseline in the Percentage of Nights With "no Nighttime Awakenings"

Patients are reporting symptoms by using an electronic diary. The electronic diary has 9 symptom questions each morning and each evening. One of the symptom questions of the morning questionnaire relates to the number of awakenings due to COPD symptoms during the previous night. The answer with the lowest symptom score is "no waking due to symptoms." A night with "no nighttime awakening" is defined from diary data as any night where the patient did not wake up due to symptoms. The change from baseline in the percentage of nights with "no nighttime awakening" is calculated from the mean percentage of nights with this answer over the 12 week treatment period, with the baseline being The baseline is calculated from the run-in epoch prior to randomization.

Change From Baseline in the Percentage of Days With "no Daytime Symptoms"

Patients are reporting symptoms by using an electronic diary. The electronic diary has 9 symptom questions each morning and each evening. Each question can be answered with one of four pre-defined answers, corresponding to a unit value of 0-3, where 0 stands for the lowest and 3 for the most severe symptom experience. A day with "no daytime symptoms" is defined from diary data as any day where the patient has recorded in the evening no cough, no wheeze, no production of sputum, and no feeling of breathlessness (other than when running) during the past approximately 12 hours in the evening questionnaire. The change from baseline in the percentage of days with "no daytime symptoms" is calculated from the mean percentage of days with this answer over the 12 week treatment period, with the baseline being. The baseline is calculated from the run-in epoch prior to randomization.

Change From Baseline in Percentage of "Days Able to Perform Usual Daily Activities"

Patients are reporting symptoms by using an electronic diary. The electronic diary has 9 symptom questions each morning and each evening. One of the symptom questions of the evening questionnaire relates to the impact of COPD symptoms on the performance of usual daily activities ("Did your respiratory symptoms stop you performing your usual daily activities today"). The answer with the lowest symptom score is "not at all." A "day able to perform usual daily activities" is defined from diary data as any day where the patient was not prevented from performing their usual daily activities due to respiratory symptoms. The change from baseline in the percentage of "days able to perform usual daily activities" is calculated from the mean percentage of days with this answer over the 12 week treatment period, with the baseline beingThe baseline is calculated from the run-in epoch prior to randomization.

Change From Baseline in Forced Vital Capacity at All Individual Timepoints

The Forced Vital Capacity (FVC)assessments for all individual time points of the serial measurements on day 1 and at week 12 are analyzed. Serial lung function measurements are taken at the following time points following dosing on Day 1 and at week 12: 5 min, 15 min, 1:00 h, 2:00 h, 4:00 h, 6:00 h, 8:00 h, and 11:55 h after the morning dose. For week 12 (day 85), the pre-dose measurements (-45 min and -15 min) and the trough measurements (23:15 h and 23:45 h post-dose) are included. The endpoints are the change from baseline in FVC following the morning dose on Day 1 and at Week 12. Where the FVC at any one timepoint is smaller than at baseline, a negative value can occur.

Change From Baseline in Mean Trough Forced Vital Capacity

Mean trough Forced Vital Capacity (FVC) is assessed as the arithmetic mean of two FVC measurements, conducted within the last hour of a 24 hours period from a morning dose, either that of day 1 or at week 12 of treatment (23:15 h and 23:45 h assessments). The endpoints are the change from baseline in trough FVC on Day 1 and at Week 12, with the mean of the -45 min and -15 min measurements on Day 1 as the baseline.

Change From Baseline in Morning and Nighttime Symptom Scores

Patients are reporting morning and nighttime symptoms by using an electronic diary. The electronic diary has 9 symptom questions each morning and each evening. Each question can be answered with one of four pre-defined answers, corresponding to a unit value of 0-3, where 0 stands for the lowest and 3 for the most severe symptom experience. Morning and nighttime symptoms scores for each patient over 12 weeks are reported and analyzed. Symptom scores are calculated as the mean of the symptom scores (morning symptom scores or nighttime symptom scores, respectively) for each patient over 12 weeks (Day 1 to week 12). The baseline is calculated from the run-in epoch prior to randomization. The outcome is calculated as the change from baseline in the morning and nighttime symptom scores, respectively. A negative number indicates a reduction in the symptom severity and is owed to the calculation of the change from baseline.

Full Information

NCT ID

NCT01715298

First Posted

October 24, 2012

Last Updated

March 9, 2015

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01715298

Brief Title

NVA237 BID Versus Placebo Twelve-week Efficacy Study

Official Title

A 12-week Multi-center, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of NVA237 in Stable COPD Patients

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (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

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 will be tested against a placebo treatment. The primary criterion to assess efficacy will be the difference between the serial lung function measurements of patients who have been treated for 12 weeks with NVA237 versus those that have received placebo treatment for 12 weeks. A serial lung function measurement (FEV1 testing) will be conducted and the "area under the curve" will be the measure for the ability to breathe.

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 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

432 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NVA237

Arm Type

Experimental

Arm Description

NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks

Intervention Type

Drug

Intervention Name(s)

NVA237

Intervention Description

NVA237 (Glycopyrronioum bromide) as a powder for inhalation in single-dose capsules

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo powder for inhalation in single-dose capsules (matching those for NVA237).

Primary Outcome Measure Information:

Title

Change From Baseline in Standardized Area Under the Curve for Forced Expiratory Volume in One Second Post Dosing

Description

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Change From Baseline in Standardized Area Under the Curve (AUC(0-12h)) for Forced Expiratory Volume in One Second Post Dosing

Description

Time Frame

Day 1

Title

Change From Baseline in Standardized Area Under The Curve for Forced Expiratory Volume in One Second for Different Time Spans Post Dosing

Description

Time Frame

Day 1 and Week 12

Title

Change From Baseline in Forced Expiratory Volume in One Second at All Individual Timepoints

Description

Time Frame

Day 1 and week 12

Title

Mean Trough Forced Expiratory Volume in One Second

Description

Time Frame

Day 1 and week 12

Title

Change From Baseline in the Health Status Assessed by St. George's Respiratory Questionnaire

Description

Time Frame

Week 12

Title

Breathlessness Assessed by Transition Dyspnea Index

Description

Time Frame

Week 12

Title

Change From Baseline in Mean Number of Puffs of Rescue Medication Per Day

Description

Time Frame

Baseline and week 12

Title

Change From Baseline in the Percentage of Days Without Rescue Medication Use

Description

Patients report the number of puffs of rescue medication (salbutamol / albuterol) using an electronic diary. The use of rescue medication is analyzed as the change from baseline in the percentage of days without usage of rescue medication over the 12 weeks treatment period. The baseline is calculated as the percentage of days without usage of rescue medication from during the the run-in epoch prior to randomization.

Time Frame

Baseline and week 12

Title

Change From Baseline in Daily Symptom Scores

Description

Time Frame

day 1 to week 12

Title

Change From Baseline in the Percentage of Nights With "no Nighttime Awakenings"

Description

Time Frame

Day 1 and week 12

Title

Change From Baseline in the Percentage of Days With "no Daytime Symptoms"

Description

Patients are reporting symptoms by using an electronic diary. The electronic diary has 9 symptom questions each morning and each evening. Each question can be answered with one of four pre-defined answers, corresponding to a unit value of 0-3, where 0 stands for the lowest and 3 for the most severe symptom experience. A day with "no daytime symptoms" is defined from diary data as any day where the patient has recorded in the evening no cough, no wheeze, no production of sputum, and no feeling of breathlessness (other than when running) during the past approximately 12 hours in the evening questionnaire. The change from baseline in the percentage of days with "no daytime symptoms" is calculated from the mean percentage of days with this answer over the 12 week treatment period, with the baseline being. The baseline is calculated from the run-in epoch prior to randomization.

Time Frame

Day 1 to week 12

Title

Change From Baseline in Percentage of "Days Able to Perform Usual Daily Activities"

Description

Time Frame

Day 1 to week 12

Title

Change From Baseline in Forced Vital Capacity at All Individual Timepoints

Description

Time Frame

Day 1 and week 12

Title

Change From Baseline in Mean Trough Forced Vital Capacity

Description

Time Frame

Day 1 and week 12

Title

Change From Baseline in Morning and Nighttime Symptom Scores

Description

Time Frame

Day 1 to week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: 1. Patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with airflow obstruction of level 2 and 3 according to the current Global initiative for chronic Obstructive Lung Disease (GOLD) strategy (2011). 2. Patients with Forced Expiratory Volume in one second (FEV1) ≥ 30% and <80 % of the predicted normal, and FEV1/FVC < 0.70 when measured 45 min after the inhalation of 84 µg ipratropium bromide. 3. Current or ex-smokers with at least 10 cigarette pack years smoking history. Exclusion criteria: Patients with a history of long QT syndrome, with a prolonged QTc measured during screening, or patients who have a clinically significant ECG abnormality at screening. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. Pregnant or nursing (lactating) women. Women of childbearing potential unless using an effective method of contraception. Patients who in the judgment of the investigator, would be at potential risk if enrolled into the study. Patients who have a clinically significant concomitant disease at screening, including but not limited to clinically significant laboratory abnormalities, clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities, or with uncontrolled diabetes, which could interfere with the assessment of the efficacy and safety of the study treatment. Patients with a body mass index (BMI) of more than 40 kg/m2. Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to anticholinergic agents, long and short acting beta-2 agonists, or sympathomimetic amines. Patients with any history of asthma, with onset of symptoms prior to age 40 years, or patients with a high blood eosinophil count during screening. Other protocol-defnied 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

*See Various Dept.'s*

State/Province

Arizona

Country

United States

Facility Name

Novartis Investigative Site

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

Novartis Investigative Site

City

Fresno

State/Province

California

ZIP/Postal Code

93726

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

Yorba Linda

State/Province

California

ZIP/Postal Code

92886-7921

Country

United States

Facility Name

Novartis Investigative Site

City

Yorba Linda

State/Province

California

ZIP/Postal Code

92886

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United States

Facility Name

Novartis Investigative Site

City

Boulder

State/Province

Colorado

ZIP/Postal Code

80304

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United States

Facility Name

Novartis Investigative Site

City

Wheat Ridge

State/Province

Colorado

ZIP/Postal Code

80033

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United States

Facility Name

Novartis Investigative Site

City

Lynn Haven

State/Province

Florida

ZIP/Postal Code

32444

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United States

Facility Name

Novartis Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33173

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United States

Facility Name

Novartis Investigative Site

City

Port Orange

State/Province

Florida

ZIP/Postal Code

32127

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United States

Facility Name

Novartis Investigative Site

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32789

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United States

Facility Name

Novartis Investigative Site

City

Conyers

State/Province

Georgia

ZIP/Postal Code

30094

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United States

Facility Name

Novartis Investigative Site

City

River Forest

State/Province

Illinois

ZIP/Postal Code

60305

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United States

Facility Name

Novartis Investigative Site

City

Skokie

State/Province

Illinois

ZIP/Postal Code

60076

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United States

Facility Name

Novartis Investigative Site

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Evansville

State/Province

Indiana

ZIP/Postal Code

47714

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United States

Facility Name

Novartis Investigative Site

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Lexington

State/Province

Kentucky

ZIP/Postal Code

40509

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United States

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Sunset

State/Province

Louisiana

ZIP/Postal Code

70584

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United States

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Novartis Investigative Site

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Fall River

State/Province

Massachusetts

ZIP/Postal Code

02720

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United States

Facility Name

Novartis Investigative Site

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North Dartmouth

State/Province

Massachusetts

ZIP/Postal Code

02747

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United States

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Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55402

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United States

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Plymouth

State/Province

Minnesota

ZIP/Postal Code

55441

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United States

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Saint Louis

State/Province

Missouri

ZIP/Postal Code

63128

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United States

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Novartis Investigative Site

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St. Charles

State/Province

Missouri

ZIP/Postal Code

63301

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United States

Facility Name

Novartis Investigative Site

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St. Louis

State/Province

Missouri

ZIP/Postal Code

63141

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United States

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Fremont

State/Province

Nebraska

ZIP/Postal Code

68025

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United States

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Lincoln

State/Province

Nebraska

ZIP/Postal Code

68510

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United States

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Novartis Investigative Site

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Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

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United States

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Novartis Investigative Site

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Cherry Hill

State/Province

New Jersey

ZIP/Postal Code

08003

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United States

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Novartis Investigative Site

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Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87108

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United States

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Novartis Investigative Site

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Brooklyn

State/Province

New York

ZIP/Postal Code

11229

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United States

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Novartis Investigative Site

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Brooklyn

State/Province

New York

ZIP/Postal Code

11234

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United States

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Novartis Investigative Site

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Great Neck

State/Province

New York

ZIP/Postal Code

11021

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United States

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Novartis Investigative Site

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Massapequa

State/Province

New York

ZIP/Postal Code

11758

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United States

Facility Name

Novartis Investigative Site

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New Windsor

State/Province

New York

ZIP/Postal Code

12553

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United States

Facility Name

Novartis Investigative Site

City

New York

State/Province

New York

ZIP/Postal Code

10003

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United States

Facility Name

Novartis Investigative Site

City

New York

State/Province

New York

ZIP/Postal Code

10028

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United States

Facility Name

Novartis Investigative Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

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United States

Facility Name

Novartis Investigative Site

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Cincinnati

State/Province

Ohio

ZIP/Postal Code

45231

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United States

Facility Name

Novartis Investigative Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

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United States

Facility Name

Novartis Investigative Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45245

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United States

Facility Name

Novartis Investigative Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43213

Country

United States

Facility Name

Novartis Investigative Site

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504-8741

Country

United States

Facility Name

Novartis Investigative Site

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Novartis Investigative Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97213

Country

United States

Facility Name

Novartis Investigative Site

City

Langhorne

State/Province

Pennsylvania

ZIP/Postal Code

19047

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United States

Facility Name

Novartis Investigative Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15243

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United States

Facility Name

Novartis Investigative Site

City

Pottstown

State/Province

Pennsylvania

ZIP/Postal Code

19464

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United States

Facility Name

Novartis Investigative Site

City

Tipton

State/Province

Pennsylvania

ZIP/Postal Code

16684

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United States

Facility Name

Novartis Investigative Site

City

East Providence

State/Province

Rhode Island

ZIP/Postal Code

02914

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United States

Facility Name

Novartis Investigative Site

City

Fort Mill

State/Province

South Carolina

ZIP/Postal Code

29707

Country

United States

Facility Name

Novartis Investigative Site

City

Rock Hll

State/Province

South Carolina

ZIP/Postal Code

29732

Country

United States

Facility Name

Novartis Investigative Site

City

Denton

State/Province

Texas

ZIP/Postal Code

76210

Country

United States

Facility Name

Novartis Investigative Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Novartis Investigative Site

City

Midvale

State/Province

Utah

ZIP/Postal Code

84047

Country

United States

Facility Name

Novartis Investigative Site

City

South Burlington

State/Province

Vermont

ZIP/Postal Code

05403

Country

United States

Facility Name

Novartis Investigative Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23219

Country

United States

Facility Name

Novartis Investigative Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23233

Country

United States

Facility Name

Novartis Investigative Site

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28848879

Citation

Kerwin E, Siler TM, Korenblat P, White A, Eckert JH, Henley M, Patalano F, D'Andrea P. Efficacy and Safety of Twice-Daily Glycopyrrolate Versus Placebo in Patients With COPD: The GEM2 Study. Chronic Obstr Pulm Dis. 2016 Mar 28;3(2):549-559. doi: 10.15326/jcopdf.3.2.2015.0157.

Results Reference

derived

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NVA237 BID Versus Placebo Twelve-week Efficacy Study

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NVA237 BID Versus Placebo Twelve-week Efficacy Study

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