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Trial record 41 of 7496 for:    Area Under Curve

NVA237 Versus Placebo 12-week Efficacy Study

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ClinicalTrials.gov Identifier: NCT01709864
Recruitment Status : Completed
First Posted : October 18, 2012
Results First Posted : February 12, 2015
Last Update Posted : March 4, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease
Interventions Drug: NVA237
Drug: Placebo
Enrollment 440
Recruitment Details  
Pre-assignment Details  
Arm/Group Title NVA237 Placebo
Hide Arm/Group 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.
Period Title: Overall Study
Started 222 219
Full Analysis Set (FAS) 222 [1] 216 [1]
Per Protocol Set (PPS) 204 [2] 201 [2]
Completed 215 208
Not Completed 7 11
Reason Not Completed
Physician Decision             0             1
subject/guardian decision             5             6
Lost to Follow-up             1             0
non-compliance with study treatment             1             1
Adverse Event             0             2
Death             0             1
[1]
FAS included all randomized patients who received at least one dose of trial drug.
[2]
PPS included all patients in the FAS who did not have any major protocol deviations.
Arm/Group Title NVA237 Placebo Total
Hide Arm/Group 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. Total of all reporting groups
Overall Number of Baseline Participants 222 219 441
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 222 participants 219 participants 441 participants
62.7  (8.36) 62.1  (8.34) 62.4  (8.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 222 participants 219 participants 441 participants
Female
98
  44.1%
87
  39.7%
185
  42.0%
Male
124
  55.9%
132
  60.3%
256
  58.0%
1.Primary Outcome
Title Change From Baseline of Standardized Area Under the Curve (AUC) for Forced Expiratory Volume in One Second (FEV1) Post Dosing
Hide Description The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) post dosing (FEV1 AUC) at week 12 of treatment. Serial lung function measurements are taken at various time points following dosing at week 12 to calculate the AUC.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title NVA237 Placebo
Hide Arm/Group 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.
Overall Number of Participants Analyzed 222 216
Least Squares Mean (Standard Error)
Unit of Measure: liters*hr
0.125  (0.0162) -0.014  (0.0165)
2.Secondary Outcome
Title Change From Baseline in Trough FEV1 and Pre-dose Trough FEV1 by Visit
Hide Description Trough Forced Expiratory Volume in one second (FEV1) is the mean of FEV1 at 23h 15min and 23h 45min after the morning dose of the previous day. Pre-dose trough FEV1 is the mean of FEV1 at -45min and -15min before morning dose
Time Frame Day 2, 86 (trough) Day 15, 29, 57, 85 (pre-dose trough)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title NVA237 Placebo
Hide Arm/Group 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.
Overall Number of Participants Analyzed 222 216
Least Squares Mean (Standard Error)
Unit of Measure: liters
Trough FEV1 Day 2 (n=218, n=214) 0.141  (0.0124) 0.025  (0.0122)
Trough FEV1 Day 86 (n=218, n=214) 0.123  (0.0171) 0.007  (0.0173)
Pre-dose Trough FEV1 Day 15 (n=217, n=208) 0.112  (0.0135) -0.002  (0.0135)
Pre-dose Trough FEV1 Day 29 (n=217, n=208) 0.0105  (0.0137) -0.005  (0.0136)
Pre-dose Trough FEV1 Day 57 (n=217, n=208) 0.0106  (0.0156) -0.006  (0.0157)
Pre-dose Trough FEV1 Day 85 (n=217, n=208) 0.090  (0.0155) -0.029  (0.0157)
3.Secondary Outcome
Title Change From Baseline in FEV1 AUC (0-12H) at Day 1 and FEV1 AUC (0-4h), AUC (4-8h), AUC (8-12h) at Day 1 and Week 12 (Day 85)
Hide Description The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) is assessed for different time spans 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 time points post dosing on day 1 and at week 12 to calculate the AUC for these different time spans.
Time Frame Day 1 and Week 12 (Day 85)
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title NVA237 Placebo
Hide Arm/Group 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.
Overall Number of Participants Analyzed 222 216
Least Squares Mean (Standard Error)
Unit of Measure: liters*hr
FEV1, AUC 0-12h Day 1 (n=222, n=216) 0.140  (0.0108) -0.001  (0.0106)
FEV1, AUC 0-4h Day 1 (n=222, n=216) 0.174  (0.0103) 0.021  (0.0101)
FEV1, AUC 0-4h Day 85 (n=222, n=216) 0.171  (0.0163) 0.001  (0.0167)
FEV1, AUC 4-8h Day 1 (n=222, n=215) 0.138  (0.0123) 0.001  (0.0121)
FEV1, AUC 4-8h Day 85 (n=222, n=215) 0.115  (0.0172) -0.017  (0.0174)
FEV1, AUC 8-12h Day 1 (n=222, n=215) 0.102  (0.0122) -0.037  (0.0120)
FEV1, AUC 8-12h Day 85 (n=222, n=215) 0.074  (0.0166) -0.034  (0.0168)
4.Secondary Outcome
Title Change From Baseline in the Health Status Assessed by St. George’s Respiratory Questionnaire
Hide Description 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).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title NVA237 Placebo
Hide Arm/Group 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.
Overall Number of Participants Analyzed 210 192
Least Squares Mean (Standard Error)
Unit of Measure: score
-4.4  (0.96) -1.7  (0.96)
5.Secondary Outcome
Title Percentage of Participants With a Clinically Important Improvement of >=4units in the SGRQ Total Score at Week 12
Hide Description The health status, as reported by the patients, is assessed using the St. George’s Respiratory Questionnaire (SGRQ). 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 significant improvement in SGRQ is defined as less than or equal to -4 change from baseline.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title NVA237 Placebo
Hide Arm/Group 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.
Overall Number of Participants Analyzed 210 192
Measure Type: Number
Unit of Measure: percentage of participants
49.0 40.6
6.Secondary Outcome
Title Breathlessness Assessed by Transition Dyspnea Index (TDI) Focal Score at Week 12
Hide Description Breathlessness at week 12 is measured using the Transition Dyspnea Index (TDI). On day 1, breathlessness is assessed by the Baseline Dyspnea Index (BDI). Patients are considered to have clinically significant improvement with the TDI score change versus BDI being equal to or greater than 1. TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title NVA237 Placebo
Hide Arm/Group 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.
Overall Number of Participants Analyzed 200 188
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
1.46  (0.289) 0.54  (0.286)
7.Secondary Outcome
Title Change From Baseline of Daily Symptom Scores
Hide Description Patients reported symptoms using an electronic diary.The diary has 9 symptom questions each am and each pm. Each question can be answered w/1 of 4 pre-defined answers, with a unit value of 0-3, 0 is least & 3 is most severe symptom.Symptom scores are calculated as the mean of combined daily symptom scores(combined from am & pm)for each patient over 12 weeks. The baseline is calculated from the run-in epoch prior to randomization.The change from baseline is in LS mean daily symptom scores over the 12 weeks. If the mean score over the 12 weeks is lower than the baseline, result is (-).A neg. result indicates an improvement in COPD symptom severity. Patients may have met the min. response requirements for the night scores(am questions),but not for the day scores(pm questions)or vice versa, the # of patients analyzed can vary between both day & night scores. Therefore, the # of patients analyzed for the combined daily symptom score can vary from the #s for individual day & night scores.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title NVA237 Placebo
Hide Arm/Group 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.
Overall Number of Participants Analyzed 211 204
Least Squares Mean (Standard Error)
Unit of Measure: Score
-1.39  (0.139) -1.01  (0.135)
8.Secondary Outcome
Title Change From Baseline of Morning and Nighttime Symptom Scores at Week 12
Hide Description Patients reported symptoms using an electronic diary.The diary has 9 symptom questions each am & each pm.Each question can be answered w/1 of 4 pre-defined answers,with a unit value of 0-3, 0 is least & 3 is most severe symptom.Symptom scores are calculated as the mean of the symptom scores(either the score assessed in am for the previous 12 hrs-referred to as nighttime scores,or the score assessed in pm for the previous 12 hrs-referred to as the daytime symptom score) for each patient over 12 weeks.The baseline is calculated from the run-in epoch prior to randomization.The change from baseline is in LS mean daily symptom scores over the 12 weeks. If the mean score over the 12 weeks is lower than the baseline, result is (-).A neg. result indicates an improvement in COPD symptom severity. the # of patients analyzed can vary between both day & night scores. Therefore, the # of patients analyzed for the combined daily symptom score can vary from the #s for individual day & night scores.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the full analysis set (FAS), who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed only and included all randomized patients who received at least one dose of study drug.
Arm/Group Title NVA237 Placebo
Hide Arm/Group 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.
Overall Number of Participants Analyzed 222 216
Least Squares Mean (Standard Error)
Unit of Measure: score
Daytime total symptom score (n=208,202) -1.14  (0.133) -0.73  (0.130)
nighttime total symptom score (n=207,202) -1.22  (0.143) -0.95  (0.139)
9.Secondary Outcome
Title Percentage of Nights With "no Nighttime Awakenings"
Hide Description Patients are reporting symptoms by using an electronic diary. A night with "no nighttime awakening" is defined from diary data as any night where the patient did not wake up due to symptoms. Percentage of no nighttime awakenings from Baseline up to 12 weeks.
Time Frame from Baseline up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title NVA237 Placebo
Hide Arm/Group 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.
Overall Number of Participants Analyzed 207 202
Least Squares Mean (Standard Error)
Unit of Measure: percentage of nights
13.3  (2.00) 11.3  (1.97)
10.Secondary Outcome
Title Percentage of Days With "no Daytime Symptoms"
Hide Description Patients are reporting symptoms by using an electronic diary. 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. The percentage of days is calculated by the number of days with no daytime symptoms/total number of days with evaluable data X 100.
Time Frame from Baseline up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title NVA237 Placebo
Hide Arm/Group 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.
Overall Number of Participants Analyzed 208 202
Least Squares Mean (Standard Error)
Unit of Measure: percentage of days
5.1  (1.65) 2.5  (1.62)
11.Secondary Outcome
Title Percentage of "Days Able to Perform Usual Daily Activities"
Hide Description Patients are reporting symptoms by using an electronic diary. 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.
Time Frame from Baseline up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title NVA237 Placebo
Hide Arm/Group 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.
Overall Number of Participants Analyzed 208 202
Least Squares Mean (Standard Error)
Unit of Measure: pecentage of days
8.6  (2.20) 1.8  (2.15)
12.Secondary Outcome
Title The Average Number of Puffs of Rescue Medication Per Day
Hide 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 mean daily number of puffs used per patient over the 12 weeks treatment period.
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title NVA237 Placebo
Hide Arm/Group 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.
Overall Number of Participants Analyzed 211 204
Least Squares Mean (Standard Error)
Unit of Measure: number of puffs
-1.63  (0.180) -0.86  (0.177)
13.Secondary Outcome
Title Percentage of Days Without Rescue Medication Use
Hide 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 percentage of days without usage of rescue medication over the 12 weeks treatment period. The baseline is calculated from the run-in epoch prior to randomization.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title NVA237 Placebo
Hide Arm/Group 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.
Overall Number of Participants Analyzed 209 202
Least Squares Mean (Standard Error)
Unit of Measure: percentage of days
16.6  (2.37) 10.5  (2.31)
14.Secondary Outcome
Title Change From Baseline of Forced Vital Capacity (FVC) at All Individual Timepoints at Day 1 and at Week 12 (Day 85)
Hide Description The Forced Vital Capacity (FVC) assessments for all individual time points of the serial measurements on day 1 and at week 12 are analyzed.
Time Frame Baseline, Day 1 and Week 12 (Day 85)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title NVA237 Placebo
Hide Arm/Group 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.
Overall Number of Participants Analyzed 222 216
Least Squares Mean (Standard Error)
Unit of Measure: liters
DAY 1/ 5 min (n=221, 214) 0.175  (0.0152) 0.037  (0.0152)
DAY 1/ 15 min (n=222, 216) 0.265  (0.0181) 0.044  (0.0180)
DAY 1/ 1h (n=222, 216) 0.318  (0.0207) 0.032  (0.0205)
DAY 1/ 2h (n=221, 216) 0.351  (0.0216) 0.071  (0.0213)
DAY 1/ 4h (n=220, 213) 0.290  (0.0235) 0.067  (0.0231)
DAY 1/ 6h (n=221, 214) 0.252  (0.0235) 0.022  (0.0234)
DAY 1/ 8h (n=220, 214) 0.192  (0.0221) -0.009  (0.0220)
DAY 1/ 11h 55min (n=216, 207) 0.152  (0.0234) -0.030  (0.0235)
DAY 85/ -45 min (n=217, 208) 0.162  (0.0289) -0.043  (0.0296)
DAY 85/ -15 min (n=216, 208) 0.156  (0.0283) -0.017  (0.0287)
DAY 85/ 5 min (n=221, 214) 0.184  (0.0282) -0.007  (0.0287)
DAY 85/ 15 min (n=222, 216) 0.263  (0.0288) -0.003  (0.0294)
DAY 85/ 1h (n=222, 216) 0.258  (0.0297) 0.004  (0.0302)
DAY 85/ 2h (n=221, 216) 0.277  (0.0299) 0.033  (0.0307)
DAY 85/ 4h (n=220, 213) 0.215  (0.0317) 0.076  (0.0321)
DAY 85/ 6h (n=221, 214) 0.199  (0.0304) -0.015  (0.0305)
DAY 85/ 8h (n=220, 214) 0.128  (0.0303) -0.023  (0.0305)
DAY 85/ 11h 55min (n=216, 207) 0.110  (0.0286) -0.006  (0.0288)
15.Secondary Outcome
Title Change From Baseline of Forced Expiratory Volume in One Second (FEV1) at All Individual Timepoints at Day 1 and at Week 12 (Day 85)
Hide Description 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 Frame Baseline, Day 1 and Week 12 (Day 85)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title NVA237 Placebo
Hide Arm/Group 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.
Overall Number of Participants Analyzed 222 216
Least Squares Mean (Standard Error)
Unit of Measure: liters
DAY 1/ 5 min (n=221, 214) 0.074  (0.0075) 0.015  (0.0074)
DAY 1/ 15 min (n=222, 216) 0.129  (0.0085) 0.015  (0.0084)
DAY 1/ 1h (n=222, 216) 0.176  (0.0108) 0.008  (0.0106)
DAY 1/ 2h (n=221, 216) 0.198  (0.0120) 0.031  (0.0118)
DAY 1/ 4h (n=220, 213) 0.168  (0.0132) 0.028  (0.0129)
DAY 1/ 6h (n=221, 214) 0.132  (0.0135) 0.000  (0.0134)
DAY 1/ 8h (n=220, 214) 0.113  (0.0129) -0.022  (0.0128)
DAY 1/ 11h 55min (n=216, 207) 0.083  (0.0131) -0.046  (0.0131)
DAY 85/ -45 min (n=217, 208) 0.092  (0.0154) -0.040  (0.0158)
DAY 85/ -15 min (n=216, 208) 0.090  (0.0160) -0.022  (0.0162)
DAY 85/ 5 min (n=221, 214) 0.118  (0.0161) -0.018  (0.0163)
DAY 85/ 15 min (n=222, 216) 0.171  (0.0164) -0.016  (0.0168)
DAY 85/ 1h (n=222, 216) 0.178  (0.0166) -0.014  (0.0169)
DAY 85/ 2h (n=221, 216) 0.186  (0.0178) 0.006  (0.0183)
DAY 85/ 4h (n=220, 213) 0.147  (0.0180) 0.014  (0.0182)
DAY 85/ 6h (n=221, 214) 0.120  (0.0183) -0.026  (0.0183)
DAY 85/ 8h (n=220, 214) 0.080  (0.0180) -0.036  (0.0181)
DAY 85/ 11h 55min (n=216, 207) 0.072  (0.0165) -0.043  (0.0165)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NVA237 Placebo
Hide Arm/Group 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.
All-Cause Mortality
NVA237 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
NVA237 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   11/222 (4.95%)   12/216 (5.56%) 
Cardiac disorders     
ACUTE CORONARY SYNDROME  1  1/222 (0.45%)  0/216 (0.00%) 
ACUTE MYOCARDIAL INFARCTION  1  1/222 (0.45%)  1/216 (0.46%) 
ANGINA PECTORIS  1  0/222 (0.00%)  2/216 (0.93%) 
ATRIAL FIBRILLATION  1  2/222 (0.90%)  1/216 (0.46%) 
CARDIAC ARREST  1  0/222 (0.00%)  1/216 (0.46%) 
CARDIAC FAILURE CONGESTIVE  1  0/222 (0.00%)  1/216 (0.46%) 
CORONARY ARTERY DISEASE  1  0/222 (0.00%)  2/216 (0.93%) 
VENTRICULAR TACHYCARDIA  1  0/222 (0.00%)  1/216 (0.46%) 
Gastrointestinal disorders     
PANCREATITIS  1  0/222 (0.00%)  1/216 (0.46%) 
General disorders     
NON-CARDIAC CHEST PAIN  1  1/222 (0.45%)  0/216 (0.00%) 
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME  1  1/222 (0.45%)  0/216 (0.00%) 
Infections and infestations     
BRONCHITIS  1  0/222 (0.00%)  1/216 (0.46%) 
PNEUMONIA  1  1/222 (0.45%)  0/216 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION BACTERIAL  1  0/222 (0.00%)  1/216 (0.46%) 
WOUND INFECTION  1  0/222 (0.00%)  1/216 (0.46%) 
Injury, poisoning and procedural complications     
GUN SHOT WOUND  1  1/222 (0.45%)  0/216 (0.00%) 
HEAT STROKE  1  1/222 (0.45%)  0/216 (0.00%) 
LUMBAR VERTEBRAL FRACTURE  1  0/222 (0.00%)  1/216 (0.46%) 
Investigations     
VOLUME BLOOD DECREASED  1  0/222 (0.00%)  1/216 (0.46%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
LUNG NEOPLASM MALIGNANT  1  1/222 (0.45%)  0/216 (0.00%) 
Nervous system disorders     
SUBARACHNOID HAEMORRHAGE  1  0/222 (0.00%)  1/216 (0.46%) 
Renal and urinary disorders     
RENAL FAILURE ACUTE  1  1/222 (0.45%)  0/216 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
ACUTE RESPIRATORY FAILURE  1  0/222 (0.00%)  1/216 (0.46%) 
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  2/222 (0.90%)  3/216 (1.39%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.9%
NVA237 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   72/222 (32.43%)   66/216 (30.56%) 
Ear and labyrinth disorders     
VERTIGO  1  3/222 (1.35%)  0/216 (0.00%) 
Eye disorders     
VISION BLURRED  1  2/222 (0.90%)  1/216 (0.46%) 
Gastrointestinal disorders     
ABDOMINAL PAIN  1  0/222 (0.00%)  3/216 (1.39%) 
DIARRHOEA  1  2/222 (0.90%)  2/216 (0.93%) 
DRY MOUTH  1  1/222 (0.45%)  2/216 (0.93%) 
NAUSEA  1  1/222 (0.45%)  2/216 (0.93%) 
General disorders     
FATIGUE  1  0/222 (0.00%)  2/216 (0.93%) 
OEDEMA PERIPHERAL  1  2/222 (0.90%)  2/216 (0.93%) 
Infections and infestations     
BRONCHITIS  1  3/222 (1.35%)  1/216 (0.46%) 
GASTROENTERITIS VIRAL  1  0/222 (0.00%)  2/216 (0.93%) 
INFLUENZA  1  2/222 (0.90%)  1/216 (0.46%) 
LOWER RESPIRATORY TRACT INFECTION  1  3/222 (1.35%)  0/216 (0.00%) 
NASOPHARYNGITIS  1  3/222 (1.35%)  7/216 (3.24%) 
ORAL CANDIDIASIS  1  2/222 (0.90%)  1/216 (0.46%) 
PNEUMONIA  1  3/222 (1.35%)  0/216 (0.00%) 
SINUSITIS  1  3/222 (1.35%)  2/216 (0.93%) 
TOOTH ABSCESS  1  0/222 (0.00%)  2/216 (0.93%) 
UPPER RESPIRATORY TRACT INFECTION  1  8/222 (3.60%)  6/216 (2.78%) 
UPPER RESPIRATORY TRACT INFECTION BACTERIAL  1  2/222 (0.90%)  4/216 (1.85%) 
URINARY TRACT INFECTION  1  3/222 (1.35%)  3/216 (1.39%) 
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  2/222 (0.90%)  3/216 (1.39%) 
Injury, poisoning and procedural complications     
EXCORIATION  1  2/222 (0.90%)  0/216 (0.00%) 
Investigations     
ASPARTATE AMINOTRANSFERASE INCREASED  1  0/222 (0.00%)  2/216 (0.93%) 
Metabolism and nutrition disorders     
HYPERKALAEMIA  1  1/222 (0.45%)  3/216 (1.39%) 
HYPOKALAEMIA  1  2/222 (0.90%)  0/216 (0.00%) 
Musculoskeletal and connective tissue disorders     
ARTHROPATHY  1  0/222 (0.00%)  2/216 (0.93%) 
BACK PAIN  1  2/222 (0.90%)  1/216 (0.46%) 
Nervous system disorders     
DIZZINESS  1  0/222 (0.00%)  2/216 (0.93%) 
HEADACHE  1  8/222 (3.60%)  6/216 (2.78%) 
Respiratory, thoracic and mediastinal disorders     
ACUTE RESPIRATORY FAILURE  1  0/222 (0.00%)  2/216 (0.93%) 
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  22/222 (9.91%)  26/216 (12.04%) 
COUGH  1  7/222 (3.15%)  5/216 (2.31%) 
DYSPNOEA  1  0/222 (0.00%)  2/216 (0.93%) 
NASAL CONGESTION  1  4/222 (1.80%)  4/216 (1.85%) 
OROPHARYNGEAL PAIN  1  4/222 (1.80%)  4/216 (1.85%) 
RHINORRHOEA  1  0/222 (0.00%)  2/216 (0.93%) 
Vascular disorders     
HYPERTENSION  1  2/222 (0.90%)  0/216 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
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Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01709864     History of Changes
Other Study ID Numbers: CNVA237A2317
First Submitted: October 16, 2012
First Posted: October 18, 2012
Results First Submitted: October 12, 2014
Results First Posted: February 12, 2015
Last Update Posted: March 4, 2015