Efficacy and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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Condition  Intervention  Phase 

Chronic Obstructive Pulmonary Disease 
Drug: NVA237 12.5 µg once daily Drug: NVA237 25.0 µg once daily Drug: NVA237 12.5 µg twice daily Drug: NVA237 50.0 µg once daily Drug: NVA237 25.0 µg twice daily Drug: NVA237 100.0 µg once daily Drug: NVA237 50.0 µg twice daily Drug: Placebo to NVA237 once daily 
Phase 2 
Study Type:  Interventional 
Study Design:  Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment 
Official Title:  A Randomized, Doubleblind, Placebocontrolled, 2period, Crossover Study to Assess the Efficacy and Safety of Differing Doses of NVA237 Administered Either Once Daily or Twice Daily, in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) 
 Maximal Response of Incremental Once Daily and Twice Daily Doses of NVA237 That Each Dose Achieves in Relation to the Maximal Effect of NVA237 on Trough Forced Expiratory Volume in One Second at Day 28 [ Time Frame: Day 28 ]
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. The maximal response of incremental once daily and twice daily doses of NVA237 that each dose achieves in relation to the maximal effect of NVA237 on Trough FEV1 was measured at Day 28. FEV1 was measured in response to all doses administered (see Outcome Measure #19).
All trough FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebocorrected data, and extrapolated to estimate the maximal response. All trough FEV1 data are reported as a percentage of the theoretical maximal response.
Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute postdose values.
 Trough Forced Expiratory Volume in One Second for Once and Twice Daily Regimens of NVA237 for the Same Total Daily Dose of NVA237 [ Time Frame: day 28 ]
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.
FEV1 was measured between dosing regimens (over the range 20 micrograms to 55 micrograms total daily dose) after 28 days of treatment.
Mean trough FEV1 was measured in response to all doses administered (12.5 µg q.d., 25.0 µg q.d., 12.5 µg b.i.d., 50 µg q.d., 25 µg b.i.d., 100 µg q.d., 50.0 µg b.i.d., and Placebo; see Outcome Measure # 19), and was used to compute modeled doseresponse curves for oncedaily and twicedaily regimens separately. The difference between those curves was computed at prespecified theoretical doses (20 µg, 25 µg, 30 µg, 35 µg, 40 µg, 45 µg, 50 µg, and 55 µg) chosen at points likely to show the largest differences between the oncedaily and twicedaily regimens. The theoretical responses to each dosing schedule separately and the difference between the oncedaily and twicedaily regimens are represented below.
 Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve 024 Hours at Day 28 of Treatment [ Time Frame: 5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28 ]
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.
Percentage of the maximal response of NVA237 doses on FEV1 Area Under the Curve (AUC) 024 hours at day 28 of treatment was calculated from measurements taken at 5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28.
AUC FEV1 was measured in response to all doses administered (see Outcome Measure #20). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebocorrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response.
 Forced Expiratory Volume in One Second AUC 024 Hours for Once and Twice Daily Regimens of NVA237 for the Same Total Daily Dose of NVA237, After 28 Days of Treatment [ Time Frame: 25 min,15 min (predose); 5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28 ]
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.
The Area Under the Curve (AUC) 024 hours FEV1 between dosing regimens over the range 20 micrograms to 55 micrograms total daily dose at 25 min,15 min (predose); 5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28.
AUC 024 hours FEV1 was measured in response to all doses administered (12.5 µg q.d., 25.0 µg q.d., 12.5 µg b.i.d., 50 µg q.d., 25 µg b.i.d., 100 µg q.d., 50.0 µg b.i.d., and Placebo; see Outcome Measure # 20), and was used to compute modeled doseresponse curves for oncedaily and twicedaily regimens separately. The difference between those curves was computed at prespecified theoretical doses (20 µg, 25 µg, 30 µg, 35 µg, 40 µg, 45 µg, 50 µg, and 55 µg) chosen at points likely to show the largest differences between the oncedaily and twicedaily regimens.
 Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve at Different Time Points (04 Hours, 08 Hours, 012 Hours, 1224 Hours) on Day 28 [ Time Frame: 5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28 ]
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.
Percentage of the maximal response of NVA237 doses on FEV1 Area Under the Curve (AUC) 04 Hours, 08 Hours, 012 Hours, 1224 Hours were calculated from measurements taken at: 5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28.
AUC FEV1 was measured in response to all doses administered (see Outcome Measure #21). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebocorrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response.
 Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second at 12 Hours at Day 28 of Treatment [ Time Frame: 12 hours on day 28 ]
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response within different doses/regimens of NVA237 was measured using FEV1 at 12 hours on day 28 of treatment.
FEV1 was measured in response to all doses administered (see Outcome Measure #22). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebocorrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response.
 Percentage of the Maximal Response of NVA237 Doses on Peak Forced Expiratory Volume in One Second at Day 28 of Treatment [ Time Frame: day 28 ]
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Peak FEV1 is the maximum FEV1 recorded in a predetermined period of time.
Percentage of the maximal response of NVA237 within different doses/regimens of NVA237 on Peak FEV1 was measured at day 28 of treatment.
Peak FEV1 was measured in response to all doses administered (see Outcome Measure #23). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebocorrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response.
 Percentage of the Maximal Response of NVA237 Doses on Forced Vital Capacity at Day 28 of Treatment [ Time Frame: day 28 ]
Percentage of the maximal response of NVA237 within different doses/regimens of NVA237 on Forced Vital Capacity (FVC) was measured at day 28 of treatment. FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
FVC at day 28 of treatment was measured via spirometry (see Outcome Measure #24). All FVC responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebocorrected data, and extrapolated to estimate the maximal response. All FVC data are reported as a percentage of the theoretical maximal response.
 Percentage of the Maximal Response of NVA237 Doses on Trough Forced Expiratory Volume in One Second at Days 1, 7 and 14 [ Time Frame: Days 1, 7 and 14 ]
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses on Trough FEV1 was measured on Days 1, 7 and 14.
Through FEV1 was measured in response to all doses administered (see Outcome Measure #25). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebocorrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response.
Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute postdose values.
 Percentage of the Maximal Effect of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve 024 Hours on Days 1 and 14 of Treatment [ Time Frame: 5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on days 1 and 14 ]
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.
Percentage of the maximal response of NVA237 doses on FEV1 Area Under the Curve (AUC) 024 hours, was calculated from measurements taken at 5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on days 1 and 14.
FEV1 AUC 024 hours was measured on days 1 and 14 of treatment in response to all doses administered (see Outcome Measure #26). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebocorrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response.
 Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve 04 Hours on Days 1, 7 and 14 of Treatment [ Time Frame: 5 min,15 min, 1,2,3,4 hours (postdose) on Days 1, 7 and 14 ]
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.
Percentage of the maximal response of NVA237 doses on FEV1 Area Under the Curve (AUC) 04 hours was calculated from measurements taken at 5 min,15 min, 1,2,3,4 hours (postdose) on Days 1, 7 and 14, in response to all doses administered (see Outcome Measure #27).
All AUC FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebocorrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response.
 Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second of Area Under the Curve 08 Hours Days 1, 7, and 14 [ Time Frame: at 5 min,15 min, 1,2,3,4,6,8 hours (postdose) on days 1, 7 and 14 ]
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses on FEV1 Area Under the Curve (AUC) 08 was calculated from measurements taken at 5 min,15 min, 1,2,3,4,6,8 hours (postdose) on days 1, 7, and 14.
AUC FEV1 was measured in response to all doses administered (see Outcome Measure #28). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebocorrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response.
 Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve 012 Hours at Day 1 and 14 of Treatment [ Time Frame: 5 min,15 min, 1,2,3,4,6,8,10 hours, 11h 55 min (postdose) on days 1 and 14 ]
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses was calculated on FEV1 Area Under the Curve (AUC) 012 hours from measurements taken at at 5 min,15 min, 1,2,3,4,6,8,10 hours, 11h 55 min (postdose) on days 1 and 14 in response to all doses administered (see Outcome Measure #29).
All AUC FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebocorrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response.
 Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second of Area Under the Curve 1224 Hours Over Days 1, and 14 of Treatment [ Time Frame: 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on Days 1 and 14 ]
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 on FEV1 Area under the curve (AUC) 1224 hours was calculated from measurements taken at 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on Days 1 and 14.
AUC FEV1 was measured in response to all doses administered (see Outcome Measure #30). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebocorrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response.
 Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second at 12 Hours on Days 1 and 14 of Treatment [ Time Frame: Days 1 and 14 ]
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses on FEV1 at 12 hours was measured on days 1 and 14.
FEV1 was measured in response to all doses administered (see Outcome Measure #31). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebocorrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response.
 Percentage of the Maximal Response of NVA237 Doses on Peak Forced Expiratory Volume in One Second on Days 1, 7 and 14 of Treatment [ Time Frame: Days 1, 7, and 14 ]
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Peak FEV1 is the maximum FEV1 recorded in a predetermined period of time.
Percentage of the maximal response of NVA237 doses on Peak FEV1 was measured on days 1, 7 and 14 of treatment.
Peak FEV1 was measured in response to all doses administered (see Outcome Measure #32). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebocorrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response.
 Percentage of the Maximal Response of NVA237 Doses on Trough Forced Vital Capacity on Days 1, 7 and 14 [ Time Frame: Days 1, 7 and 14 ]
Percentage of the maximal response of NVA237 Doses on Trough Forced Vital Capacity (FVC) on Days 1, 7 and 14. FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was assessed via spirometry. (see Outcome Measure #33).
Trough FVC is defined as the mean of the FVC values measured at 23 hours 15 mins and 23 hours 45 mins postdose.
 Mean Daily Use of Rescue Medication by Treatment at Different Time Points [ Time Frame: Baseline, Weeks 1, 2, 3 and 4 ]Mean daily use of rescue medication by treatment and time points. Baseline was defined as the average of the total number of puffs of rescue medication during the week prior to treatment start, divided by the total number of days with nonmissing rescue data during that week, then puffs were counted during weeks 1, 2, 3 and 4 postdose.
 Trough Forced Expiratory Volume in One Second by Treatment at Day 28 [ Time Frame: Day 28 ]
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.
Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute postdose values.
 Forced Expiratory Volume in One Second Area Under the Curve 024 Hours at Day 28 of Treatment [ Time Frame: 5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28 ]
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.
FEV1 Area Under the Curve (AUC) measurements were taken at 5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28. FEV1 AUC was calculated as the sum of trapezoids divided by the length of time.
 Forced Expiratory Volume in One Second Area Under the Curve at Different Time Points (04 Hours, 08 Hours, 012 Hours, 1224 Hours) [ Time Frame: 5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28 ]
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.
FEV1 Area Under the Curve (AUC) measurements were taken at: 5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose). FEV1 AUC was calculated as the sum of trapezoids divided by the length of time.
 Forced Expiratory Volume in One Second at 12 Hours on Day 28 of Treatment [ Time Frame: 12 hours on day 28 ]Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.
 Peak Forced Expiratory Volume in One Second at Day 28 of Treatment [ Time Frame: 25 min , 15 min predose, 5 min, 15 min, 1 , 2 ,3 , 4 , 6 , 8 , 10 hours , 11 hour 55 min and 14 hour postdose on day 28 ]
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.
Peak FEV1 is the maximum FEV1 recorded in a predetermined period of time. Measurements were taken at 25 min , 15 min predose, 5 min, 15 min, 1 , 2 ,3 , 4 , 6 , 8 , 10 hours , 11 hour 55 min and 14 hour postdose on day 28.
 Trough Forced Vital Capacity After 28 Days of Treatment [ Time Frame: 23 hours 15 mins and 23 hours 45 mins postdose on Day 28 ]Forced Vital Capacity (FVC) after 28 days of treatment. FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. Trough FVC was defined as the mean of the FVC values measured at 23 hours 15 mins and 23 hours 45 mins postdose.
 Trough Forced Expiratory Volume in One Second at Days 1, 7 and 14 [ Time Frame: 23 hours 15 mins and 23 hours 45 mins postdose on Days 1, 7 and 14 ]
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.
Trough FEV1 was measured on Days 1, 7 and 14 of treatment. Trough FEV1 was defined as the mean of the FEV1 values measured at 23 hours 15 mins and 23 hours 45 mins postdose.
 Forced Expiratory Volume in One Second Area Under the Curve 024 Hours on Days 1 and 14 of Treatment [ Time Frame: 5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on days 1 and 14 ]
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.
FEV1 Area Under the Curve (AUC) measurements were taken at 5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on days 1 and 14 of treatment. FEV1 AUC was calculated as the sum of trapezoids divided by the length of time.
 Forced Expiratory Volume in One Second Area Under the Curve 04 Hours on Days 1, 7 and 14 of Treatment [ Time Frame: 5 min,15 min, 1,2,3,4 hours (postdose) on Days 1, 7 and 14 ]
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.
FEV1 Area Under the Curve (AUC) measurements were taken at 5 min, 15 min, 1,2,3,4 hours (postdose) on days 1, 7 and 14 of treatment. FEV1 AUC was calculated as the sum of trapezoids divided by the length of time.
 Forced Expiratory Volume in One Second of Area Under the Curve 08 Hours Days 1, 7, and 14 [ Time Frame: at 5 min,15 min, 1,2,3,4,6,8 hours (postdose) on days 1, 7 and 14 ]Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses on FEV1 Area Under the Curve (AUC) 08 was calculated from measurements taken at 5 min,15 min, 1,2,3,4,6,8 hours (postdose) on days 1, 7, and 14. FEV1 AUC was calculated as the sum of trapezoids divided by the length of time.
 Forced Expiratory Volume in One Second Area Under the Curve 012 Hours at Day 1 and 14 of Treatment [ Time Frame: 5 min,15 min, 1,2,3,4,6,8,10 hours, 11h 55 min (postdose) on days 1 and 14 ]Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses was calculated on FEV1 Area Under the Curve (AUC) 012 hours from measurements taken at at 5 min,15 min, 1,2,3,4,6,8,10 hours, 11h 55 min (postdose) on days 1 and 14. FEV1 AUC was calculated as the sum of trapezoids divided by the length of time.
 Forced Expiratory Volume in One Second of Area Under the Curve 1224 Hours Over Days 1, and 14 of Treatment [ Time Frame: 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on Days 1 and 14 ]Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 on FEV1 Area under the curve (AUC) 1224 hours was calculated from measurements taken at 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on Days 1 and 14. FEV1 AUC was calculated as the sum of trapezoids divided by the length of time.
 Forced Expiratory Volume in One Second at 12 Hours on Days 1 and 14 of Treatment [ Time Frame: Days 1 and 14 ]Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses on FEV1 at 12 hours was measured on days 1 and 14.
 Peak Forced Expiratory Volume in One Second on Days 1, 7 and 14 of Treatment [ Time Frame: Days 1, 7, and 14 ]
Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Peak FEV1 is the maximum FEV1 recorded in a predetermined period of time.
Percentage of the maximal response of NVA237 doses on Peak FEV1 was measured on days 1, 7 and 14 of treatment.
 Trough Forced Vital Capacity on Days 1, 7 and 14 [ Time Frame: Days 1, 7 and 14 ]
Trough Forced Vital Capacity (FVC) on Days 1, 7 and 14. FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. (see Outcome Measure #23).
Trough FVC was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute postdose values.
Enrollment:  388 
Study Start Date:  April 2010 
Study Completion Date:  December 2010 
Primary Completion Date:  December 2010 (Final data collection date for primary outcome measure) 
Arms  Assigned Interventions 

Experimental: NVA237 12.5 µg q.d.
NVA237 12.5 µg once daily

Drug: NVA237 12.5 µg once daily
NVA237 12.5 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2.

Experimental: NVA237 25.0 µg q.d.
NVA237 25.0 µg once daily

Drug: NVA237 25.0 µg once daily
NVA237 25.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2.

Experimental: NVA237 12.5 µg b.i.d.
NVA237 12.5 µg twice daily

Drug: NVA237 12.5 µg twice daily
NVA237 12.5 µg via dry powder inhaler twice daily for 28 days during either period 1 or during period 2.

Experimental: NVA237 50.0 µg q.d.
NVA237 50.0 µg once daily

Drug: NVA237 50.0 µg once daily
NVA237 50.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2.

Experimental: NVA237 25.0 µg b.i.d.
NVA237 25.0 µg twice daily

Drug: NVA237 25.0 µg twice daily
NVA237 25.0 µg via dry powder inhaler twice daily for 28 days during either period 1 or during period 2.

Experimental: NVA237 100.0 µg q.d.
NVA237 100.0 µg once daily

Drug: NVA237 100.0 µg once daily
NVA237 100.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2.

Experimental: NVA237 50.0 µg b.i.d.
NVA237 50.0 µg twice daily

Drug: NVA237 50.0 µg twice daily
NVA237 50.0 µg via dry powder inhaler twice daily for 28 days during either period 1 or during period 2.

Placebo Comparator: Placebo
Placebo to NVA237 once daily

Drug: Placebo to NVA237 once daily
Placebo to NVA237 via dry powder inhaler once daily for 28 days during either period 1 or during period 2.

Ages Eligible for Study:  40 Years and older (Adult, Senior) 
Sexes Eligible for Study:  All 
Accepts Healthy Volunteers:  No 
Inclusion Criteria:
 Male and female patients age 40 years or more
 Diagnosis of Chronic Obstructive Lung Disease (COPD) (moderate to severe as classified by the Global Initiative for COPD (GOLD) Guidelines, 2008
 Smoking history of at least 10 packyears
 Postbronchodilator Forced Expiratory Volume in 1 second (FEV1) <80% and ≥30% of the predicted normal value
 Postbronchodilator FEV1/Forced Vital Capacity (FVC) <0.7
 Symptomatic patients, according to daily electronic diary data between visit 2 (Day 8) and Visit 3 (Day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to visit 3
Exclusion Criteria:
 Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to the first visit
 Patients who have had a respiratory tract infection within 4 weeks prior to the first visit
 Patients with concomitant pulmonary disease
 Patients with diabetes Type I or uncontrolled diabetes Type II
 Any patient with lung cancer or a history of lung cancer
 Patients with a history of certain cardiovascular comorbid conditions
 Patients with a history of asthma or a blood eosinophil count >600/mm3 or onset of symptoms prior to 40 years
 Patients with eczema, known high IgE levels or a known positive skin prick test
 Patients participating in the active phase of a pulmonary rehabilitation programme
 Patients contraindicated for the treatment with anticholinergics, long and shortacting beta2 agonists or sympathomimetic amines
 Patients with a history of alpha1 antitrypsin deficiency
 Patients on long term oxygen therapy (>15hr per day)
 Other protocoldefined inclusion/exclusion criteria may apply
Please refer to this study by its ClinicalTrials.gov identifier: NCT01119950
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Study Director:  Novartis Pharmaceuticals  Novartis Pharmaceuticals 
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party:  Novartis Pharmaceuticals 
ClinicalTrials.gov Identifier:  NCT01119950 History of Changes 
Other Study ID Numbers:  CNVA237A2208 200901403811 
Study First Received:  May 5, 2010 
Results First Received:  January 23, 2013 
Last Updated:  March 3, 2015 
Keywords provided by Novartis:
COPD 
Additional relevant MeSH terms:
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Glycopyrrolate Adjuvants, Anesthesia 
Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs 
ClinicalTrials.gov processed this record on January 19, 2017