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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVA237 | Experimental | NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks |
|
| Placebo | Placebo Comparator | Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVA237 | Drug | NVA237 (Glycopyrronioum bromide) as a powder for inhalation in single-dose capsules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
Other protocol-defnied inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | *See Various Dept.'s* | Arizona | United States | |||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28848879 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | NVA237 | NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks |
| FG001 | Placebo | Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo |
| Drug |
Placebo powder for inhalation in single-dose capsules (matching those for NVA237). |
|
| Day 1 |
| 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. | Day 1 and Week 12 |
| 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. | Day 1 and week 12 |
| 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 | Day 1 and week 12 |
| 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). | Week 12 |
| 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. | Week 12 |
| 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. | Baseline and week 12 |
| 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. | Baseline and week 12 |
| 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. | day 1 to week 12 |
| 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. | Day 1 and week 12 |
| 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. | Day 1 to week 12 |
| 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. | Day 1 to week 12 |
| 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. | Day 1 and week 12 |
| 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. | Day 1 and week 12 |
| 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. | Day 1 to week 12 |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Novartis Investigative Site | Fresno | California | 93726 | United States |
| Novartis Investigative Site | Fullerton | California | 92835 | United States |
| Novartis Investigative Site | Yorba Linda | California | 92886-7921 | United States |
| Novartis Investigative Site | Yorba Linda | California | 92886 | United States |
| Novartis Investigative Site | Boulder | Colorado | 80304 | United States |
| Novartis Investigative Site | Wheat Ridge | Colorado | 80033 | United States |
| Novartis Investigative Site | Lynn Haven | Florida | 32444 | United States |
| Novartis Investigative Site | Miami | Florida | 33173 | United States |
| Novartis Investigative Site | Port Orange | Florida | 32127 | United States |
| Novartis Investigative Site | Winter Park | Florida | 32789 | United States |
| Novartis Investigative Site | Conyers | Georgia | 30094 | United States |
| Novartis Investigative Site | River Forest | Illinois | 60305 | United States |
| Novartis Investigative Site | Skokie | Illinois | 60076 | United States |
| Novartis Investigative Site | Evansville | Indiana | 47714 | United States |
| Novartis Investigative Site | Lexington | Kentucky | 40509 | United States |
| Novartis Investigative Site | Sunset | Louisiana | 70584 | United States |
| Novartis Investigative Site | Fall River | Massachusetts | 02720 | United States |
| Novartis Investigative Site | North Dartmouth | Massachusetts | 02747 | United States |
| Novartis Investigative Site | Minneapolis | Minnesota | 55402 | United States |
| Novartis Investigative Site | Plymouth | Minnesota | 55441 | United States |
| Novartis Investigative Site | Saint Charles | Missouri | 63301 | United States |
| Novartis Investigative Site | St Louis | Missouri | 63128 | United States |
| Novartis Investigative Site | St Louis | Missouri | 63141 | United States |
| Novartis Investigative Site | Fremont | Nebraska | 68025 | United States |
| Novartis Investigative Site | Lincoln | Nebraska | 68510 | United States |
| Novartis Investigative Site | Omaha | Nebraska | 68114 | United States |
| Novartis Investigative Site | Cherry Hill | New Jersey | 08003 | United States |
| Novartis Investigative Site | Albuquerque | New Mexico | 87108 | United States |
| Novartis Investigative Site | Brooklyn | New York | 11229 | United States |
| Novartis Investigative Site | Brooklyn | New York | 11234 | United States |
| Novartis Investigative Site | Great Neck | New York | 11021 | United States |
| Novartis Investigative Site | Massapequa | New York | 11758 | United States |
| Novartis Investigative Site | New Windsor | New York | 12553 | United States |
| Novartis Investigative Site | New York | New York | 10003 | United States |
| Novartis Investigative Site | New York | New York | 10028 | United States |
| Novartis Investigative Site | Charlotte | North Carolina | 28207 | United States |
| Novartis Investigative Site | Cincinnati | Ohio | 45231 | United States |
| Novartis Investigative Site | Cincinnati | Ohio | 45242 | United States |
| Novartis Investigative Site | Cincinnati | Ohio | 45245 | United States |
| Novartis Investigative Site | Columbus | Ohio | 43213 | United States |
| Novartis Investigative Site | Medford | Oregon | 97504-8741 | United States |
| Novartis Investigative Site | Medford | Oregon | 97504 | United States |
| Novartis Investigative Site | Portland | Oregon | 97213 | United States |
| Novartis Investigative Site | Langhorne | Pennsylvania | 19047 | United States |
| Novartis Investigative Site | Pittsburgh | Pennsylvania | 15243 | United States |
| Novartis Investigative Site | Pottstown | Pennsylvania | 19464 | United States |
| Novartis Investigative Site | Tipton | Pennsylvania | 16684 | United States |
| Novartis Investigative Site | East Providence | Rhode Island | 02914 | United States |
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| Novartis Investigative Site | Denton | Texas | 76210 | United States |
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| Novartis Investigative Site | Midvale | Utah | 84047 | United States |
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| Novartis Investigative Site | Richmond | Virginia | 23233 | United States |
| Novartis Investigative Site | Tacoma | Washington | 98405 | United States |
| Full Analysis Set (FAS) |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | NVA237 | NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks |
| BG001 | Placebo | Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. analyzed participants had values at both baseline and the corresponding time frame, i.e. week 12 | Posted | Least Squares Mean | Standard Error | Liters | Week 12 |
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| Secondary | 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. | The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Day 1 | Posted | Least Squares Mean | Standard Error | Liters | Day 1 |
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| Secondary | 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. | The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Day 1and Week 12 | Posted | Least Squares Mean | Standard Error | Liters | Day 1 and Week 12 |
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| Secondary | 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. | The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Day 1and Week 12 | Posted | Mean | Standard Deviation | Percent | Day 1 and week 12 |
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| Secondary | 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 | The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Day 1and Week 12 | Posted | Least Squares Mean | Standard Error | Liters | Day 1 and week 12 |
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| Secondary | 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). | The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Week 12 | Posted | Least Squares Mean | Standard Error | Score | Week 12 |
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| Secondary | 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. | The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Week 12 | Posted | Least Squares Mean | Standard Error | Score | Week 12 |
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| Secondary | 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. | The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Week 12 | Posted | Least Squares Mean | Standard Error | Number of puffs | Baseline and week 12 |
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| Secondary | 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. | The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 12 | Posted | Least Squares Mean | Standard Error | percentage of days | Baseline and week 12 |
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| Secondary | 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. | The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame. | Posted | Least Squares Mean | Standard Error | Score | day 1 to week 12 |
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| Secondary | 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. | The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization | Posted | Least Squares Mean | Standard Error | Percentage of nights | Day 1 and week 12 |
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| Secondary | 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. | The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization | Posted | Least Squares Mean | Standard Error | Percentage of days | Day 1 to week 12 |
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| Secondary | 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. | The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization | Posted | Least Squares Mean | Standard Error | Percentage of days | Day 1 to week 12 |
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| Secondary | 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. | The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization | Posted | Least Squares Mean | Standard Error | Liters | Day 1 and week 12 |
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| Secondary | 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. | The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization | Posted | Least Squares Mean | Standard Error | Liters | Day 1 and week 12 |
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| Secondary | 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. | The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization | Posted | Least Squares Mean | Standard Error | Score | Day 1 to week 12 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NVA237 | NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks | 9 | 216 | 88 | 216 | ||
| EG001 | Placebo | Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks | 5 | 214 | 81 | 214 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| HERPES SIMPLEX | Infections and infestations | MedDRA | Systematic Assessment |
| |
| OPHTHALMIC HERPES ZOSTER | Infections and infestations | MedDRA | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA | Systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| METASTATIC SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA OF THE VULVA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| PULMONARY MASS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| PERIPHERAL ARTERY ANEURYSM | Vascular disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| VISION BLURRED | Eye disorders | MedDRA | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| CANDIDA INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| ORAL CANDIDIASIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
| |
| ACCIDENTAL OVERDOSE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| MUSCLE STRAIN | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| BLOOD PRESSURE INCREASED | Investigations | MedDRA | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| RESPIRATORY TRACT CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| RHINITIS ALLERGIC | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D008171 | Lung Diseases |
| D008173 | Lung Diseases, Obstructive |
| D012140 | Respiratory Tract Diseases |
| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D006024 | Glycopyrrolate |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
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