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Trial record 82 of 10795 for:    Placebo AND once

Safety and Tolerability of 28 Days Treatment With Glycopyrronium Bromide (NVA237) (100 or 200 µg Once a Day) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00510510
Recruitment Status : Completed
First Posted : August 2, 2007
Results First Posted : January 21, 2011
Last Update Posted : May 21, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease (COPD)
Interventions Drug: NVA237 100 µg
Drug: Placebo
Drug: NVA237 200 µg
Enrollment 281
Recruitment Details  
Pre-assignment Details  
Arm/Group Title NVA237 100 µg NVA237 200 µg Placebo
Hide Arm/Group Description NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days. NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days. Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
Period Title: Overall Study
Started 92 98 91
Completed 87 89 74
Not Completed 5 9 17
Reason Not Completed
Adverse Event             4             3             6
Lack of Efficacy             0             1             1
Subjects no longer requires study drug             0             0             2
Withdrawal by Subject             1             2             3
Lost to Follow-up             0             0             1
Protocol Violation             0             3             4
Arm/Group Title NVA237 100 µg NVA237 200 µg Placebo Total
Hide Arm/Group Description NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.. NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days. Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days. Total of all reporting groups
Overall Number of Baseline Participants 92 98 91 281
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 92 participants 98 participants 91 participants 281 participants
64.2  (7.93) 62.6  (9.04) 63.4  (9.44) 63.4  (8.82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 98 participants 91 participants 281 participants
Female
35
  38.0%
29
  29.6%
27
  29.7%
91
  32.4%
Male
57
  62.0%
69
  70.4%
64
  70.3%
190
  67.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 98 participants 91 participants 281 participants
Hispanic or Latino
17
  18.5%
15
  15.3%
11
  12.1%
43
  15.3%
Not Hispanic or Latino
72
  78.3%
79
  80.6%
76
  83.5%
227
  80.8%
Unknown or Not Reported
3
   3.3%
4
   4.1%
4
   4.4%
11
   3.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 98 participants 91 participants 281 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   1.0%
0
   0.0%
1
   0.4%
Black or African American
0
   0.0%
3
   3.1%
3
   3.3%
6
   2.1%
White
90
  97.8%
94
  95.9%
88
  96.7%
272
  96.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   2.2%
0
   0.0%
0
   0.0%
2
   0.7%
1.Primary Outcome
Title Safety of Treatment With NVA237 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Hide Description The assessment of safety was based on adverse events, particularly those adverse events known to be associated to treatment with muscarinic antagonists. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Sections.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NVA237 100 µg NVA237 200 µg Placebo
Hide Arm/Group Description:
NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days..
NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
Overall Number of Participants Analyzed 92 98 91
Measure Type: Number
Unit of Measure: Participants
Total number of patients with any AE 26 26 24
Total number with any significant AE 3 4 6
2.Secondary Outcome
Title Least Squares Means of Trough Forced Expiratory Volume in One Second (FEV1), by Day
Hide Description Forced expiratory volume maneuvers recorded using a calibrated spirometer. Trough forced expiratory volume in one second (FEV1) on Days 1 & 28 defined as the mean of the FEV1 values measured at 23 hours 15 minutes and 23 hours 45 minutes post-dose.
Time Frame 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NVA237 100 µg NVA237 200 µg Placebo
Hide Arm/Group Description:
NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days..
NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
Overall Number of Participants Analyzed 92 98 91
Least Squares Mean (Standard Error)
Unit of Measure: Liters
Trough FEV1 Day 1 1.465  (0.0152) 1.480  (0.0149) 1.334  (0.0154)
Trough FEV1 Day 28 1.502  (0.0182) 1.492  (0.0180) 1.341  (0.0200)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NVA237 100 µg NVA237 200 µg Placebo
Hide Arm/Group Description NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.. NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days. Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
All-Cause Mortality
NVA237 100 µg NVA237 200 µg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
NVA237 100 µg NVA237 200 µg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/92 (0.00%)   1/98 (1.02%)   1/91 (1.10%) 
Infections and infestations       
Pneumonia  1  0/92 (0.00%)  1/98 (1.02%)  0/91 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1 [1]  0/92 (0.00%)  0/98 (0.00%)  1/91 (1.10%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
[1]
Chronic obstructive pulmonary disease exacerbation
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NVA237 100 µg NVA237 200 µg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/92 (7.61%)   10/98 (10.20%)   4/91 (4.40%) 
Gastrointestinal disorders       
Dry mouth  1  3/92 (3.26%)  7/98 (7.14%)  0/91 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  5/92 (5.43%)  3/98 (3.06%)  4/91 (4.40%) 
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.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00510510     History of Changes
Other Study ID Numbers: CNVA237A2206
First Submitted: August 1, 2007
First Posted: August 2, 2007
Results First Submitted: December 23, 2010
Results First Posted: January 21, 2011
Last Update Posted: May 21, 2012